Podcasts about cder

Pink Sheet editors consider ex-FDA officials' advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53). More On These Topics From The Pink Sheet Trump's US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA's Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible': https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/exit-interview-us-fdas-patrizia-cavazzoni-says-cder-staff-in-best-place-possible-IN6GTBFEJZDSNOI4T23CRYK7OY/ Innovation Drives Divergence: US FDA Drugs and Biologics Centers Follow Own Trajectories: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/innovation-drives-divergence-us-fda-drugs-and-biologics-centers-follow-own-trajectories-MDZ5DSCKKNEYPF6PVTXAMFHGF4/ US FDA's Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/us-fdas-median-review-time-remains-less-than-one-year-despite-swell-of-missed-goal-dates-VIEE6AVOQRGMZNKB53B52GPQG4/ Clocking The Speed Of US FDA 2024 Novel Approvals: https://insights.citeline.com/pink-sheet/pink-sheet-perspectives/clocking-the-speed-of-us-fda-2024-novel-approvals-3HT7CAIO4VBJDIJZVGBHLAUCSY/

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni's surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA's decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway': https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/

Did team members in your practice have to have any hard conversations this year? Maybe about dress code or drug testing? Did that new PTO policy work? Were there uncomfortable topics with patients? Tiff and Dana give advice on how to go about updating your handbook as 2024 comes to an end, so you can be more ready than ever when 2025 begins. Episode resources: Subscribe to The Dental A-Team podcast Join Dental A-Team Consulting Leave us a review Transcript: The Dental A Team (00:01.422) Hello, Dental A Team listeners. We are so excited to be here with you today. I have Dana. You guys know I love podcasting with Dana. She's my girl. Dana, thank you so much for being here with me. know we have, it's Friday, and so we're super excited about that. We have fun things in our lives coming up and we have so many podcasts to get recorded today for all of these people and I'm so excited because it means I get extra time with you. Dana, how are you today?   Dana (00:27.746) Doing good, doing good. I'm just as excited to be here. I love this time too.   The Dental A Team (00:32.202) Awesome. Awesome. And we just sprung on you guys, only asked for your permission, but we sprung on you a little meetup for the consultants here in a few weeks. And I am so excited. You guys, you listeners, I know you guys know we are all kind of like super close by. Some of us are further away in other states, but we're a fully remote company. And so we don't get to see each other a lot. And so the culture that we're able to build with our company, in my opinion, is freaking incredible because we're rarely ever   together but we are going to do a consultant meetup in a couple of weeks and we do a Live To Give every single year where Dental A Team just kind of goes back to the the communities as best we can and we do angel tree shopping or one year we dropped off coats for   homeless shelters and women's shelters and kids shelters and all these different things. We just really love to give back and so we do a live to give shopping spree basically. So in a couple weeks Dana, I'm so excited. You're gonna be here. Kristy's gonna be here. Britt is here already, but I actually will see her. Kiera's flying in. It's gonna be such a huge event and I'm just so excited to get some time to crunch some things, figure some things out for the future for us.   and do the Live To Give and get some shopping done for some kiddos. anyways, how excited are you for it though? We sprung that on you like yesterday.   Dana (01:57.814) You did. I'm truly so pumped. Anytime I can, and I say this from the bottom of my heart, get time with my consultant crew. It's some of my favorite time and they're some of my favorite people. So I would have moved heaven and earth to make that work.   The Dental A Team (02:14.302) No, thank you. I agree. It's so much fun getting all of us together and   Just getting some fun out there and getting some brainstorming. I feel like we brainstorm the best when we're side by side and I'm excited for it. Well, on that note, it's kind of our end of year wrap up is what our meeting is about. Like what is next you're going to look like and part of those this is HR Britt is what I like to call her. in our company, she handles our HR pieces and part of what I want to talk to you guys about today is really the employee manual and towards the end of the year making sure that it's wrapped up and ready to   Dana (02:28.972) Yeah.   The Dental A Team (02:50.132) to go for next year. So Dana, you had some really great ideas, you always do, on updating the employee manual and where to go about those things. And one caveat I have, number one, I love talking about companies like CEDR.   They're fantastic. C-E-D-R, you guys. If you need an employee manual, if you don't know what needs to be in there, like we have options, we have ideas, we can definitely help you through with that. But CEDR does a really great job at pulling all of your state's laws, all of those little pieces that we don't necessarily always know you might not know. So I'll always say that. Reach out to CEDR if you use them or if you need one from scratch. Updates wise, same thing. Like what does CEDR have for your state? Right now towards the end of the   year, we pretty much know what the new laws are going to be coming into effect for the next year, this next year, I know what year you're listening to this in right now. But this next year is 2025. So most of those state laws have already been passed or any federal changes or laws to employee sanctions and different pieces have already been passed. So they're already there, you just got to find them. And you've got to make sure that they're all encompassing that you've grabbed all of them. So CEDR does that for you any employment lawyer,   Most of the lawyers you guys retain for most of your business pieces can usually snag that information for you too. So just double check. know, states like California and New York have really strict employee policies, so you just want to make sure you're always on part of there. So that's like the first layer of updates for me and the easiest space to really tackle and hit. But Dana, I loved your idea and really like looking back on the year to project for the future. Will you walk us through kind of   your thoughts on that and what you used to do when you were in practice.   Dana (04:37.142) Yeah, sure. I think the end of the year is a great time to just kind of reevaluate. Did I have everything in my handbook or did situations come up throughout the year that man, I really wish I had had something in writing for that. So, you know, I had a couple instances and practices this year where like they had to like have some hard conversations around like drugs or dress code, right? And they didn't have those things defined or they didn't really know what to do because it's like, well, can I ask them to take a test? Can I ask them to wear something specific because I don't have it   in writing. So if you happen to have to have some of those hard conversations or make some uncomfortable decisions and you don't have it in writing, now is the great time as you are updating for laws or you're getting your handbook in place to begin with. Just considering throughout this year, was there anything? Did my PTO policy work? Did raises come up at times I wasn't expecting them? So maybe I put in my handbook like when I evaluate for raises or that raises are based on performance or that I follow a tier raise structure.   The Dental A Team (05:26.414) I'm stop.   Dana (05:37.664) you know, maybe we had some team members who they asked for some last-minute PTO, so like maybe we need to get in writing a little bit stronger of what the process is for getting it approved and what kind of notice they need to give. So just looking back through the year and did anything happen that man I wish I had had something in writing or this was uncomfortable because I didn't.   The Dental A Team (06:00.686) think that's fantastic, I love that whole structure there. I love that you pointed out like drug policies, things like that. Those are things I think we forget to think about often times when we initially make it because...   I mean, we're all here with the mindset that people are naturally good human beings and that things are, which not to say that they're not naturally good human beings, but sometimes what we feel like is intuitive or known or like just natural thought process just isn't the case. And we find that in literally every aspect of life. So not forgetting that when it comes to the employee manual is true as well. And making sure I think Dana, as you're talking, I'm thinking like getting so granular with it that it can't be confused or misconstrued.   that it's insanely clear that from the smallest level possible and the biggest level possible, we can understand this entire makeup of whatever this rule or whatever you want to call it is.   It made me think too about smoking breaks and where are they allowed to indulge in a cigarette if that's something that you may have a team member on your team who does that or vapes or these are all the real things. These are all common factors of everyday life. Where are those things able to be handled, be done? I know for me, my practice I worked out for years, we had that it could not be on the premises at all because we didn't want patients walking into it.   advocate it for our patients for their health and their overall you know teeth so we had to make sure that they weren't walking into it and they weren't seeing any team members who may be on the team that did partake in those so it had to be off-site completely on their lunch breaks or what have you so I think though that's something that we tend to miss until like you said we get to the situation and we're like great awesome I actually don't have something for this so carry on and we'll fix this later making sure though I   The Dental A Team (07:56.116) think too, we're having those conversations with those people. Because I can say that maybe, you know, when updates come around, and they're like, pointed, right? And then you're sitting there like, is that because of me? Did that? You don't want to make your team members feel like you're attacking them or a situation either. So I think making sure to have those conversations with them like, hey, we know that this happened. We know that this was a situation. It wasn't something I was prepped to handle. We handled it together and we did our best. We handled it beautifully.   Moving forward just so you know, there will be a policy in place for it. Thank you for bringing it to my attention. It was obviously something that I had not known I needed to put into place, but I'm really glad that it was you and we could have this conversation and get through this. I think it's better, and Dana correct me if you think I'm wrong, then like, guess what? It kind of feels underhanded, like slighted, and that's just that space of not having the ability to have what might be deemed as a difficult   conversation and it doesn't have to be difficult. Dana, how do you feel that you advise your clients because you do have a ton of clients and it is time to update those employee manuals and you just said you know you had a couple of these things come up for some of your clients this year. How did you handle that? How did you have them handle those situations as they arose and how are they going to put those into place next year?   Dana (09:17.038) Yeah, and it did come down to just like a hard conversation and hey, I don't have anything in writing and we're navigating this fresh and new together. And I'm going to set some expectations on the spot.   and you know we're going to come to an agreement and how we're going to handle this and what solutions we're going to come to and then I'm going to make sure that I have it in writing because having it in writing doesn't mean we don't have the conversation just like you said it just makes the structure of the conversation a little bit easier and there are written out measures that you can default to so I love how you said like just go ahead and have the conversation anyway it's much more awkward than just like here it is and everybody kind of knows so it is just we got to admit we don't have anything in writing we really   are going to handle it together. It is a new thing. We're just going to communicate and we're going to get through it and move on from it and make sure we've got it documented so that if that ever happens again there is that structure put in place.   The Dental A Team (10:10.092) So how did those conversations go for your clients that you worked with? one you mentioned is a pretty, that's a pretty strong policy to have to put into place. And I do understand like there are some, you know, recreational things that are out there that have been passed as laws for that it's okay for a lot of the state. So it makes it kind of difficult to navigate those pieces, but it's still considered a drug. But how did that, how did those conversations go for those clients?   Dana (10:16.238) you   Dana (10:37.154) They went well. think that they were just open and honest and that the bottom line is I have to protect my patients and I have to make sure that things that happen on the premises don't affect the way that we care for patients, the way that we speak to patients, the way that we handle patients. At the end of the day, that's what I have to protect. So these are the things that we're gonna put in place. We're going to make sure that those things don't happen again and we're gonna move forward. But at the end of the day, we're gonna protect the practice and the patients that sit in our chairs.   The Dental A Team (10:42.507) Mm-hmm.   The Dental A Team (11:02.87) Awesome. that. I love that. And I think that's a space too, where we have to not only protect our patients, but we're protecting each other and our business too. Because if you guys don't, if you guys don't put these policies in place and protect your business, where are your patients going to go? And if we're not protecting our team, meaning, you know, we can't, we can't deviate from what is considered acceptable for someone. It's got to be fair across the board. It's got to be the same structure for everyone. Because if someone gets that special treatment, the rest of   the team feel slighted or confused and then guess what is really really hard to hold accountability in any other aspect. So I really want to switch a little bit, continue this conversation but within that really talk about how important it is to make sure that we're sticking to the standards and upholding the standards that we set into place and set into motion. And from a leadership standpoint doctors, practice owners, you guys are the ones that need to make sure that this is a hundred percent accurate. Your office manager   or business administrators may be putting this together for you. They may be communicating with CEDR or your lawyers or whomever, but you guys need to make sure that it's accurate. And then from there, from a leadership standpoint, you, your leadership team, your whole team really needs to be abiding by these. I think the spaces that I see the most frequently misused, like you said Dana, was like the PTO situation or vacation time that's not paid, unpaid vacation time, sick leave, getting   to use the benefits or getting paid out the benefits at the end of the year or not. One thing that I saw a lot of clients come up against is expectations of payout when they were let go, when a team member was let go or when they quit, they didn't have it explicitly written at termination. You know, they said at termination you would be paid out, but they didn't have it explicitly written that it was if you decided to leave, I'm not paying you out, but if I decide you're leaving, I will pay it out. And so they ended up having to pay it out.   out. But from that leadership standpoint, Dana really like pushing on them to understand we've all got to follow the same rules. And this means your office manager too. And if we have different structures laid out by different positions, that is totally fine. But that needs to be clearly defined as well. I think one of the worst things we can do from a leadership standpoint is put a leader on a pedestal, make them completely different from the rest of the team. They are   The Dental A Team (13:32.23) in many ways, but make it so different that they're looked at as though they're untouchable. That there's no accountability being held in place, that they get to free for all, do whatever they want, but the team over here has to abide by these rules in this employee manual and they're like told they can't have time off and you don't even know when your manager's off. Like those pieces I think can really ruffle the team. Dana, what do you suggest to your clients as they're, because I know like I said you're building these out right now, but what are   you suggesting for your clients in respect to that? How do they go about that? And what do you think about all of that?   Dana (14:11.66) Yeah, I completely agree with you. think that there are some instances where leadership is different when I think it comes down to like policies and like procedures for team members and it's it's team members across the board, including leadership. And I think that like having your office manager your leadership team like also   live that and roll that and be active participants in this is exactly what I follow and these are the standards that I hold for myself and these are the policies that you know I'm going to also abide by I think is really super beneficial.   The Dental A Team (14:45.027) Yeah.   The Dental A Team (14:48.398) Yeah, I agree. I agree and making sure I think that they discuss those and they have conversations around them too. Wherever you guys note that people are going to be out, make sure everybody is noted on that same schedule that everything looks the same. Like Dana, like you said, doesn't have to be everyone's clear cut gets the same because I know tenure, I know based on, you know, your position in the practice, especially PTO, things like that might be different, but you want it to be across the   board as similarly spoken as we can get.   One huge note for practice owners, business managers, all of you guys, things like that, PTO, amount of PTO that we get, payroll, our pay, bonuses, payouts, anything like that needs to be a no-go. We do suggest that this is in your employee manual, that there's no discussions around what I make. I should not be talking to Dana in a practice about, as my position, this is what I make.   my bonus looks like. I actually had a practice recently. The whole hygiene department is turned upside down right now because we had an issue where this was discussed and   We worked really hard to make it hygienist very happy and meet all of the needs and requirements that were asked for that went above and beyond as not by a lot, but above and beyond where some other team members may have been in an effort to keep this person on staff. We know how difficult it is right now to find team members, but especially hygienists and that information was asked to be.   The Dental A Team (16:37.474) been kept quiet, it was not kept quiet and there's an entire team very upset, understandably, and now a doctor who's, you know, overhead is about to be pretty upside down for the next couple of months due to the fact. So I want to make it really clear and the team members that are listening, I don't say that so that you guys are slighted, so that you guys don't know what's going on, so you guys don't have the information. I say it because I truly feel with everything that I have, I always have   believed this and I believe this about myself. If you are worth more than what you're paying, what you're paid, you believe you are worth more than what you are paid, you need to advocate for that and you need to not expect other people to just show you how they feel you should be paid. Like they, a lot of us, think, I don't know how to say this, a lot of us feel as though our worth is shown to us by other people based off what they think we should be paid.   That's not always the case. My worth is from inside. My worth is what I think I am worthy of, what I think I can do, how I can show up. I want team members to understand that. I want team members to understand that it's not always equal and fair. Tenure makes a huge difference. The amount of time that you've been in the industry, how long you've been doing the specific position that you've been doing, what do you add to the bottom line of the practice for that position?   to add more value, ask how you can. Those are really great ways to be compensated more, to be shown your worth and your value in compensation. But on the flip side of that, as business owners and doctors and leaders, we need to make sure that it's very clear that those things are kept under wraps because it just makes really good employees feel really bad sometimes. So make sure things like that are in there. You know, just spitballing things, Dana and I have seen this here.   and making sure you guys are set. So I think the biggest piece is Dana, I loved your like take a look backwards on the year of what has happened, what's popped up, what's spiked that you think needs attention or you didn't have a policy and you wished you did. I love that. Making sure you communicate with somebody about the laws of your area. So whether it's CEDR, whether it's an employee, an employment lawyer or your lawyer that you have.   The Dental A Team (19:02.014) deemed as your practice. Again, there's states that are heavier in employee laws than other states. If you're in a heavy state, you typically know that. Please be careful. Please make sure you follow all of the guidelines. I implore that upon you. Dana and I live, luckily for us, it's very easy or it was very easy when we were in practice to do these and it didn't take much from CDER to like update the employee manuals because it was very easy, but I know there are some states, especially on each of our borders there.   that are a little tighter around that coastline. So state updates and laws, holidays, PTO, etc. Anything weird that you've come up against that you were like, this is so weird and I didn't even think about this. I don't want you to...   think about everything. I don't want you to think that it's going to happen every single year, you're going to have something new. So write it down, brainstorm it and have a space, would say, Dana, you'll probably do this too. Have a space in your active drive where it's like, hey, these are things I'm going to update next year. Last piece, I will say, have everyone sign an employee update every year, whether you do updates or not. The employee manual should be gone through. It should be something that's just like open and honest, spoken about all the time so that there's no questions. know you still have   I always get confused about my PTO when I was in practice. like, I don't know how many years I've been here. I don't know how much I have. My manager was like, I don't know why this is so hard. And I was like, I don't know.   This is where we're at. So I think just talking about it constantly, making sure everybody understands it and making those updates and then making those changes solid with a good signature is always best. Dana, I love that idea. I love that you had some talking points today. Those were fantastic. Thank you so much for this. guys, Dana's going to help me with an operations manual update one as well. We know she's my ops queen. So Dana, thank you so much and I hope you...   The Dental A Team (20:53.674) enjoy recording the rest of the podcasts with me today. Awesome. Thank you guys so much, and we'll catch you next time.

Resumen Informativo de Radio Diputados correspondiente a la semana del 16 al 20 de diciembre de 2024, con los testimonios de: ▪️Diputado Bruno Sarubi ▪️Diputado Juan Rossi ▪️Diputada Stefanía Cora ▪️Esteban Sbresso, organizador de la Maratón de Reyes ▪️Gustavo Hein, presidente CDER

A través de un proyecto de Gabriela Lena, la CDER declaró de interés la 22° Fiesta Provincial del Salame, que se realizará el 11 de enero en Chajarí. Al respecto, Radio Diputados conversó con el organizador, Lucho Castro.

Por un proyecto de la diputada Mariana Bentos, la CDER declaró de interés la 50° Fiesta Provincial del Estudiante Secundario, que se llevará a cabo este sábado 2 de noviembre en la ciudad de Villaguay. Al respecto, Radio Diputados conversó con Juan Pablo Lozano, docente de la Escuela Técnica, organizadora de la Fiesta.

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations. Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them. Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.

Pink Sheet reporter and editors discuss new developments in the FDA's plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development. More On These Topics From The Pink Sheet Artificial Intelligence: CDER's New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role

From simple biomarker tests to cutting-edge precision medicine, the diagnostics industry is navigating a complex landscape of regulatory changes and technological advancements. In this episode, Andrew L'Huillier, a leader in the diagnostics industry and Director of Regulatory Affairs Liaison - Diagnostics at Merck, discusses his work on FlowScript and other groundbreaking diagnostic products. Learn about the challenges and opportunities in regulatory compliance, drug discovery, and the implementation of cGMP guidelines. Tune in and discover how precision medicine is revolutionizing healthcare and improving patient care! Resources: Connect with and follow Andrew L'Huillier on LinkedIn. Follow Merck on LinkedIn. Explore the Merck Website! Subscribe to the CDER, CBER, and CDRH newsletters! Discover AgencyIQ and 360Dx!

”Selvom jeg er brun i huden, så har jeg aldrig følt mig udenfor på håndboldbanen. Det fortæller landholdshåndboldspiller Mads Mensah, når snakken falder på racisme i professionel sport. Tvært i mod, så mener Mads Mensah at der er tendens til, at medierne giver for megen opmærksomhed til ”de få idioter” der råber højt. I denne første del af ugens Portrætalbum, kan du høre Mads Mensah fortælle om sin opvækst med håndbold og barndomshjemmet, hvor Bob Marleys ”Legend” opsamlingsalbum, var en af de få CDer der kørte i høj rotation. Udsendelse nr.: 126 Vært: Anders Bøtter Klip og lyddesign: Emil Germod Redaktør: Michelle Mølgaard Andersen Produceret af: Bowie-JettSee omnystudio.com/listener for privacy information.

Send us a Text Message.Dr. Kevin Bugin, Ph.D. is Deputy Director of Operations in the Office of New Drugs ( OND - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs ) in FDA's Center for Drug Evaluation and Research ( CDER - https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ), where among his many responsibilities he serves as lead for the Center for Clinical Trial Innovation ( C3TI - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti ), a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct. Prior to his current role, from May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government's HHS and DOD operation formerly known as Operation Warp Speed. Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development. Dr. Bugin joined the FDA in 2008 in the Office of Business Process Support, then joined the Division of Gastroenterology and Inborn Errors Products within OND as a Regulatory Health Project Manager in 2010, and as the Chief of Project Management from 2015 to 2017. From 2017 until 2020, he served as the Director of Special Programs and the lead of CDER's New Drugs Regulatory Program Modernization. Prior to joining the FDA, Dr. Bugin held roles in multiple areas and phases of drug development, including discovery (molecular biology) at the Virginia Bioinformatics Institute, translational research and technology transfer at the National Institute of Health's Office of Technology Transfer, safety and pharmacovigilance with NIH's National Cancer Institute's Cancer Therapy Evaluation Program, and regulatory affairs and quality assurance at Amarex Clinical Research. Dr. Bugin received a BS in Biology and Chemistry from Virginia Tech in 2005, an MS in Biotechnology from American University in 2006, and a PhD in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in US regulatory affairs (RAC) and participates in numerous policy and regulatory science program working groups across the FDA.Support the Show.

Today Mary is talking to Anna Murphy. Anna moved to Kinvara in 2001 and raised her three children here, and works in the village. Her main passion is environmental activism, and she has been  involved in Plastic Free Kinvara, Kinvara Climate Action, the Ballindereen Kinvara Tree gang and now Rights of Nature Galway. Activism gives me hope and can help with eco anxiety. " We need to re-imagine our relationship with Nature, and protect it  for this and future generations  to head off a looming sixth mass extinction"rightsofnaturegalway@gmail.comwww.ejni.net/rights-of-natureKinvara and Ballindereen tree gangwww.facebook.com/KBtreegang/Recommended book Braiding Sweetgrass by Robin Kimmerer

The rates of alcohol use disorder increased significantly since the onset of COVID-19, making this a major public health issue, though it's not discussed as frequently as opioid overdoses. Over 140,000 Americans die from the effects of alcohol in an average year (more than from drug overdoses). Ten percent of Americans over the age of 12 have Alcohol Use Disorder. And according to the 2023 Alcohol Abuse Statistics, 60% of Americans increased their alcohol consumption during COVID-19 lockdowns. In this podcast, we are joined by Dr. Iilun Murphy, Director of the Office of Generic Drugs in FDA's Center for Drug Evaluation and Research (CDER), and returning is Dr. Marta Sokolowska, CDER's Deputy Center Director for Substance Use and Behavioral Health to discuss the recent first generic approval to Vivitrol, a one-month extended-release injectable naltrexone that is used to help people recovering from opioid or alcohol dependence.

Shannon Clark is the founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy-to-use medical devices. In this episode, Shannon discusses her experience founding her company, the importance of human factors engineering, her love of history, and why she's so happy about her recent "demotion." Guest link: www.UserWiseConsulting.com Charity supported: Equal Justice Initiative Interested in being a guest on the show or have feedback to share? Email us at podcast@velentium.com.  PRODUCTION CREDITS Host: Lindsey Dinneen Editor: Tim Oliphant Producer: Velentium   SHOW TRANSCRIPT Episode 006 - Shannon Clark Lindsey Dinneen: Hi, I'm Lindsey with Velentium and I'm talking with MedTech industry leaders on how they change lives for a better world. Diane Bouis: The inventions and technologies are fascinating and so are the people who work with them. Frank Jaskulke: There was a period of time where I realized, fundamentally, my job was to go hang out with really smart people that are saving lives and then do work that would help them save more lives. Diane Bouis: I got into the business to save lives and it is incredibly motivating to work with people who are in that same business, saving or improving lives. Duane Mancini: What better industry than where I get to wake up every day and just save people's lives. Lindsey Dinneen: These are extraordinary people doing extraordinary work, and this is The Leading Difference. Hello and welcome to the Leading Difference Podcast. I'm your host Lindsay, and I am excited to introduce you to my guest today, Shannon Clark. Shannon is founder and principal of UserWise, a consultancy that helps medical device manufacturers and startups to design safe and easy to use medical devices. Before founding UserWise in 2014, Shannon was a human factors engineer at Intuitive Surgical and Abbott Laboratories. Shannon graduated from UCLA with a BS in Mechanical Engineering and a technical breadth in technology management. Shannon is additionally a certified professional industrial engineer, holds two patents and has written and published three books. Clearly an absolute rockstar, thank you so much for being here, Shannon. Shannon Clark: Yeah, thanks for having me. Lindsey Dinneen: Of course. Well, I would love, if you don't mind just sharing a little bit about your background and maybe how you got to where you are. I know, you've gotten to do some really amazing things. You have an amazing company. I would just love to hear a little bit of that backstory. Shannon Clark: How far back should we go? I think it's interesting that on my application to USC, I ended up going to UCLA, but I did apply and get into USC, just for the record, and on my application. I said that my dream job, I was 17 years old, would be to run a product design firm in Spain. It's pretty interesting that I kind of ended up there and I kind of had that idea so early on, but I didn't really fall in love with human factors or even know about it until I was working at Abbott Laboratories and I had this unique opportunity to apprentice one of the world's leading experts in human factors named Ed Israelski. He was the Director of Human Factors for Abbott for many years, and laid all the groundwork for the international standards and it informed the FDA guidances around human factors, so it was a really unique opportunity to work for him. And from there I was able to really dive into human factors with that practical experience at Abbott. And I knew that I wanted to run my own company basically. And I think I, I finally made it there in 2014 when I saw some great opportunities to help fledgling companies out of Stanford Biodesign and Fogerty Institute for Innovation. And I started out with just myself consulting, and then from there built a practice and pretty soon it was 30 human factors engineers, recruiters, and operational staff as of 2022. Lindsey Dinneen: Wow. That is amazing. Congratulations. That's, that is no small accomplishment. That is amazing. So human factors engineering specifically wasn't necessarily, it sounds like, the first intention that you may have had going into school. So it's awesome to hear that having that experience is what sort of led you into your career path, but I'm kind of curious, were you always very technically minded, kind of interested in user experience growing up or what was, even going back a little further, what was the spark that interested you in that field in general? Shannon Clark: Well, I had actually never heard of engineering. My mom's a lawyer, my dad's an accountant. So I didn't know what engineering was going into college, and so I was gonna, study Latin or Spanish or something. But then I thought I don't really know what I'm gonna do after college if I study that. And I had an uncle who was an engineer who said, "you really should check this out." So I took some coursework and I thought I could probably do this. And to be honest, mechanical engineering was a big struggle for me, having not taken any of the AP courses. I took AP Latin, AP Music Theory, all the APs that you don't need for engineering. So I came into school pretty behind and feeling behind, but I made it through and I kind of had my eye on this goal of making user experiences easier for people. I was going back even further, I was really inspired by my uncle Peter Skillman, who's now with Phillips I think in their Design Center of Excellence. And he worked at IDO at the time and he was 35 years old and contributed to this project that was featured on 60 Minutes to redesign a shopping cart. And it was really inspiring to me at the age of 10 or seven or however old I was, to watch someone take something so mundane as a shopping cart and uncover all these issues that exist with shopping carts everywhere, and then completely rethink the design and improve it. And rewatching that video I can now kind of see with another lens that they even started on the basis of safety and designed for safety, which I believe is so important when prioritizing design efforts to think about, " well, how many injuries are there to toddlers every year in shopping carts and how can we address this and how can we make it better?" And then just a month ago, I actually had my toddler in a shopping cart and she got stuck because the seatbelt wouldn't unlatch. And then it made me think that's interesting, full circle. Lindsey Dinneen: Oh, that is interesting. Oh, the irony. Oh my gosh. Okay. Yeah. So designing for safety first. So I'd love to hear the evolution of you just starting this consultancy by yourself. And I mean, so you were literally doing all the things, you were marketing, you were doing the actual consulting, you were doing the accounting, I'm assuming. How did that all evolve and how did your leadership ability evolve as you've grown your business? Shannon Clark: Well, I started out with no management experience, quite young. I started out with just myself. I hired some contractors here and there in 2015 . 2016, hired my first employee and I gotta tell you, I was the worst manager. And she was like, patient zero, she's now at Intuitive Surgical. But I think overall it was a great step in her career, but good for her for getting through, I think, four years of reporting to me as I was learning to be a manager. And I think over time through trial and error, I became a better manager. That was sort of a learning experience for me. And something that people were always telling me as I was starting my company was, " you should learn on someone else's dime. Don't start a company and then learn these hard lessons on your own dime." But I'm happy that I didn't listen to them and sure there were a lot of really expensive life lessons, like the time we didn't expense $150,000 of expenses because I didn't realize that someone wasn't doing their job for four months. There's all kinds of things that happen as you're start a company. But you just have to learn from them and then embed processes to address any gaps that you uncover along the way. And so at this point, we're just such a strong company with so many internal processes and trainings and rigor, and it's really exciting to see how much it's matured over the past eight years. Lindsey Dinneen: Yeah, absolutely. Well, and correct me if I'm wrong, but it seems like you recently, in fact, had a bit of a transition even for yourself, for your role. Is that correct? Shannon Clark: Yes, we brought in a new CEO. I was able to secure significant private equity investment from a private equity firm called NaviMed. And so we're forming a new umbrella organization called ClariMed. And so that's sort of a broader quality by design thesis where we're bringing together a bunch of like-minded organizations to help support product development, specifically in the medical space. And we're starting that organization with two human factors consultancies. So it started with UserWise, my company, which was acquired in August of 2022. And then in January this year, 2023, we acquired Harvey Medical, which is a seven or eight person human factors consultancy in the UK and the Netherlands. So, that's where we're at today and I'm thrilled. I, I probably put on LinkedIn that I'm thrilled about this quote- unquote "demotion" to Principal Human Factors Engineer, 'cause previously I was Director of Human Resources, CFO, CEO, and Principal Human Factors Engineer, and it was a lot. Yeah. Let's just say I didn't get a maternity leave. But now I'm just really excited for the future and I have a CEO with 17 years experience running and growing a regulatory consultancy. So I, I'm just really excited to report to her and she's an inspiration to me every day, Kelly Kendall. Lindsey Dinneen: Awesome. That's fantastic. How has the transition been for you? Did it take a lot of transition or did it come easily? How was it for you? Shannon Clark: It's been a huge transition, cuz Kelly runs the business based on data and I think when you have investors involved, you have to really present a lot of data to them. Whereas before I didn't have to report to anyone or speak to anyone or ask anyone any questions about what I'm doing, which I think we're a lot better off now cause I'm not just making decisions as I go along. I have a, a whole support system to help me through all the decisions on a day-to-day basis. So, that's been really relaxing to share the responsibility and, and have support. But yeah, it's been a lot of work to try to come up with the data. We're trying to integrate Salesforce. We're just kind of like a small company, quickly growing, so there's a lot there to work on. Lindsey Dinneen: Yeah. Absolutely. I'm curious, is there a particular moment that stands out to you because it kind of clearly confirmed that this was the right career path for you or the correct industry? Shannon Clark: It just immediately clicked. Back when I was working for Ed Israelski at Abbott and contributing to standards committees and submitting feedback to the FDA and draft guidances on behalf of Abbott, all of that work really created a spark within me, I'd say. And I think I would pinpoint it on one project I worked on, which was to review all recalls of medical devices by the FDA over the course of time that were due to human error. So, for example, an automated external defibrillator that was on the market, I think this was 2009, where there was a low battery indicator that would blink and falsely cause individuals to cease use of the device unnecessarily. So the idea that they were confusing this red indicator light to mean, "oh, this is broken, don't use it," versus "it's just low battery. Change the battery when you have a chance, but you could have resuscitated the patient." And I wrote this 80 page internal report. All these events that had happened and it really brought to life the importance of the then new FDA focus on human factors. And the fact that you need to really intentionally bake safety into the design of products from the get-go. It's not something you can just add on post-market or even figure out through human factors validation at the end of the process. It's something that you need to think about constantly throughout design, and again, prioritize those design efforts according to risk and safety and according to patient harm and user harm so that you can, at the end, have a product that doesn't result in a recall like that. So when I saw all that data, it really centered my focus and brought clarity to me that this is something that I wanna do for the rest of my life, 10 years, 20 years. I don't know. I guess I wouldn't say for the rest of my life. But I really was super inspired to do something about it cuz I also read that there were half a million deaths every year due to preventable medical errors in hospitals alone, just in the United States. So we basically have a whole pandemic happening every year in hospitals. And some of that is due to medication errors and hospital processes. But that figure doesn't even capture instances where they amputated the wrong leg. I mean, these are deaths. And so I'm, I'm really dedicating my career to reducing that number of half a million to something lower. Lindsey Dinneen: Wow. Yeah. That's amazing. I'm so thankful for people like you that are doing that research and like you said, safety first, building it into the design from the very get-go. That's fantastic. Yeah. Shannon Clark: And I love what Velentium's doing with regards to cybersecurity. I think that definitely follows the same kind of premise of protecting users and ensuring safety. Lindsey Dinneen: Yeah, absolutely. Yeah. There is so much that goes into it. So any angles that we can take to help protect people is absolutely worth it. So, how would you define leadership or what does leadership mean to you? Shannon Clark: I think leadership to me is inspiring others to be their best selves and fulfill their own missions, whatever it may be. So sometimes I can spark someone to be inspired to follow my footsteps and become a human factors engineer. Or maybe someone wants to pursue something a little bit different and just letting them uncover their own truths and pursue their dreams. That's probably the main thing I ask in interviews, " what is your dream job?" Because I wanna make sure that you're in your dream job, whatever that may be. So I guess that's what leadership means to me. Lindsey Dinneen: I love that. Yeah, absolutely. And then what would be your best piece of advice for someone interested in obtaining a leadership role, either within the medtech industry, or very specifically following a similar career path to what you've done? What would you say to someone who that's a goal of theirs? Shannon Clark: Well, my specific path, I believe, can in fact be replicated, in that, I saw an opportunity to uniquely become an expert in a field that was emergent. And there's many emerging fields that result from regulatory shifts. And in this case, UserWise, came out of the 2011 draft guidance about human factors issued by the Food and Drug Administration that was later published as final in 2016. And so there from my position at Abbott in 2010, 2011, I was able to see that coming down the pike and I saw the huge amount of opportunity at hand, and I saw where industry was and where it would be going. And out of that, I was able to found my consultancy. So I worked tirelessly to transform myself into an expert, not only by working 12 hour days at Abbott and giving them everything I had, but also reading all the textbooks on the syllabus for human factors master's degrees at various universities and had a stack of 20 books that I was working through. So it was all sort of self-taught, but ultimately I saw this opportunity due to a shifting regulatory landscape and things like that happen all the time in all industries. And there's all these opportunities that exist that are just a great opportunity to create a new business around it whether it's consulting or software as a service. Yeah, tons of opportunities out there. Lindsey Dinneen: So sort of being open to maybe opportunities that you wouldn't have originally pinpointed for yourself, but being aware of various trends and kind of responding to the situation. Is that part of it? Shannon Clark: Yeah. I mean, ultimately, I guess I'd describe my business model, if it were to be replicated, if you wanted to have success in this manner is to uncover regulatory trends and then find an opportunity, a business opportunity within that. But I guess more generally, if you're looking for a leadership position in the medtech field, I think that expertise certainly is highly valued. And engineering abilities is also highly valued. So, I think you need to go deep before you go broad. I think I do see a lot of like marketing experts, that maybe haven't gone scientifically deep, end up as CEOs of these companies, but I think the best background of all the CEOs that I work with, I always enjoy working with CEOs that have a technical background cuz they can truly understand the ins and outs. And I, I see limitations among some of these CEOs that maybe just have sales backgrounds. Lindsey Dinneen: Sure. Yeah, that, that makes a lot of sense to me. I can understand that. Shannon Clark: I think I'm talking to a salesperson right now, so I hope I haven't offended you. Lindsey Dinneen: Not at all. I am more on the marketing engagement side of things, but I wouldn't be offended regardless, because you're right, you need both to be successful. So, absolutely. Shannon Clark: Go deep first and then go broad. That's kind of the advice that was given to me as well and I followed that advice. Lindsey Dinneen: I like it. I like that a lot. Yeah. Well, so I know from your bio that you are a published author three times. Right? I would love to hear about that and what have you written about and how did that all come about? Shannon Clark: Well, nothing too impressive, and it's quite off topic, but I really enjoy history. So I authored a history of a local neighborhood, which is actually where UserWise is located in San Jose. And so I wrote this 150 page history book and we sold I think 3000 copies. And all the funding went to fund local farmer's markets as well as ultimately the annual 4th of July parade for San Jose. So I wrote that book and then wrote a follow on, a sequel about parades in the Bay Area, California. Have you ever heard of the Pasadena Tournament of Roses? Lindsey Dinneen: I have. Shannon Clark: So, we used to have one of those in Northern California. There's a whole Northern California, Southern California rivalry. That was huge when I went to UCLA. But we used to have our parade and our parade died out with the Great Depression, and we tried to resurrect it in 1960, but it didn't work out. So it was just kind of an interesting forgotten history that I wanted to capture in a book before it got lost forever. Lindsey Dinneen: Yeah. That is awesome. Very cool. Shannon Clark: And then the third book is how to get a job in management consulting. It's called "College2Consulting." It's a silly book, but I think it's pretty helpful if you wanna get a job at LEK or some management consultancy. I didn't come up with all the material for that, but I was the ghost writer. Lindsey Dinneen: Oh, so cool. That's awesome. So what are some interesting industry trends that you are looking forward to as you continue on with UserWise and beyond? Shannon Clark: I guess when I think of industry trends, I immediately think of what's happening with Europe, with MDR, and where's the FDA headed specifically with regards to human factors cuz that's ultimately what's gonna guide where UserWise is going next. With the FDA, there's been a lot of turnover with their human factors review team over the past five years, and it's created a shift towards requiring more and more. I think that's always the story with regulations where before maybe we didn't submit a full 60 page human factors engineering submission report for a lower risk device and just submit a protocol. These days they're just rejecting a protocol if there's no full backup for all the elements found in a human factors engineering submission report. So I think overall, I guess as always there's just more and more regulations. I do hope to make some progress. I'm headed to the International Standards Committee later this month in Germany, and I hope that I can kind of start socializing some ideas around reducing the burden from an international standards standpoint for human factors. So, I guess another industry trend that's a little more specific is that we just finished our multi-year study on training decay, whereas in collaboration with the Food and Drug Administration. And to date for combination products, so drug delivery devices, you're basically required to conduct human factors testing with untrained users. And it's created a context where there's some drug delivery devices where if they were pure medical devices, they would easily get clearance. But since they're a combination product, they have a drug, they're reviewed by DMEPA, CDER, a different human factors team. They're just unapprovable because untrained users are not capable of using them successfully. So I'm hopeful that with our research, we can further promote the concept of trained usability testing and invite more devices to the table instead of requiring perfect use for combination products. That's a hope of mine. But again, with more and more regulations we'll see if that comes to fruition. Lindsey Dinneen: Yeah, of course. Yeah, that sounds like a really good path forward. So it'll be interesting to see, like you said, how the landscape changes over time. So how do you prioritize your own continued learning and growing as a leader these days? I know you mentioned having stacks of textbooks, which I love, but nowadays, how do you continue to develop your own skills and knowledge? Shannon Clark: Well, I think I mentioned earlier that I am thrilled to report to Kelly Kendall, CEO of our company. And so I learned from her every week by watching the way she runs the company, the way she makes decisions. I've just learned a ton. It's been drinking through a fire hose with regards to key performance indicators and everything to do with running a business in a more formal manner. Cuz I ran my business based purely on intuition and not really on data. And when you really get a grasp of all the data associated with a business, like she says, it's about turning knobs up and down and adjusting and fine tuning once you know what the knobs are. And so, I feel like myself professionally, I've grown so much just having a mentor continuously working with me. I have in the past had executive coaching, but that, that, pales in comparison to what I'm now able to experience having a seasoned and experienced CEO to report to. Lindsey Dinneen: Yeah, and it's completely a hundred percent relevant to you and your business, which is awesome that you get that experience. Very cool. Okay, so just for fun, imagine that someone were to offer you a million dollars to teach a masterclass on anything you want, doesn't have to be in your industry. What would you choose to teach and why? Shannon Clark: Well, I think the answer that I might be supposed to say is moderating. So I have a lot of experience moderating usability testing and minimizing bias for participants so that you can extract truth. So basically, as a moderator, you don't wanna get in the way of the truth of what a participant is experiencing or feeling or demonstrating through their interaction with a product. So we just launched a moderator course, which I'm really excited about. But I guess after having done all that work for the past months to launch that course, I need a break. So if I could teach a masterclass, I guess it would be on the history of the Maya, which right now I'm trying to learn Mayan hieroglyphs. And I have an interest in archeology. And to be honest, I know nothing about the Maya, but maybe I have a kind of a crazy overconfidence going on where I feel that I wanna learn everything about it. And I, I feel like I've done this in a couple of areas of my life where I'll learn everything about a subject and then kind of become like an expert. And so that's kinda my next side hobby. I have some ideas there about what I'm gonna do. Lindsey Dinneen: Oh, that's awesome. So what sparked your interest specifically in that? Shannon Clark: I think in part it's because I've been to Mexico a number of times. I speak Spanish. And then I have an aunt who's Mayan who was involved in kind of raising me at an early age. So, that definitely sparked my interest. And then I've been honestly, like watching a lot of TV about Ancient Apocalypse and all those shows. I don't know if you've seen them, but I was just like, oh yeah, this is so cool. Lindsey Dinneen: I love it. Yes. Isn't it great to have something outside of your main, day-to-day job life focus that just kind of brings you this other level of passion and joy-- I'll just put it, put it that way. Shannon Clark: Yeah. This is certainly, it really stems out of being able to share the burden of running a company with others namely my boss Kelly, and it opens up my time to actually think about other things. And that has been a focus for me since the transaction in August. It's something I'm excited about just to have some extra hours in my week to think about things that aren't related to work. Lindsey Dinneen: Yeah. That's fantastic. So what is the one thing you wish to be remembered for after you leave this world? Shannon Clark: I guess being a good mom and that's really all I care about. I have one daughter, her name is Emily, and she is 22 months old. And she's great. So that's definitely my focus to be a great mom. And it'd be cool to be remembered as a good contributor to the industry of human factors, but I think more importantly, I wanna be a good mom. Lindsey Dinneen: Yeah. Yeah. Absolutely. Aww. Oh my gosh. I love it. What is one thing that makes you smile every time you see or think about it? Shannon Clark: Well, my daughter Emily, obviously, lemme try to come up with a different answer. Lindsey Dinneen: Ok, it's a great answer though. Shannon Clark: Yeah, that's gotta be my answer, sorry. Lindsey Dinneen: No, that's fantastic. Well, I just want to say thank you so much for sharing a little bit about your background, about your company, about the industry, where you think things are going, and your advice. I just really appreciate your time today, and I love hearing the why behind how you got into this and what makes you tick. So, thank you. And plus, it's really fun to hear about your hobbies outside of work too. And Emily, and course Emily. So, we are honored to be making a donation on your behalf as a thank you for your time today to the Equal Justice Initiative, which provides legal representation to prisoners who may have been wrongly convicted of crimes, poor prisoners without effective representation, and others who may have been denied a fair trial. So Shannon, thank you so much for picking that organization to support today. Thank you so much for your time. We wish you continued success as you work to change lives for a better world. Shannon Clark: Thanks so much. Thanks for having me. Lindsey Dinneen: Of course. And thank you also to our listeners for tuning in and if you're feeling as inspired as I am right now, I'd love if you'd share this episode with a colleague or two, and we will catch you next time.  The Leading Difference podcast is brought to you by Velentium. Velentium is a contract design and manufacturing firm specializing in the development, production and post-market support of diagnostic and therapeutic active medical devices, including implantables and wearables for neuromodulation and other class three indications. Velentium's core competencies include electrical design, mechanical design, embedded software, mobile apps, contract manufacturing, embedded cybersecurity, OT cybersecurity, systems engineering, human factors and usability, and automated test systems. Velentium works with clients worldwide from startups seeking seed funding to established Fortune 100 companies. Visit velentium.com to explore your next step in medical device development.

Episode 7 – LuttJeg heter Astrid Kirschner, og dette er en ny episode av min podkast BAROKKPODDEN! I dagens episode skal jeg fortsette å prate om nerdete temaer fra barokken, og jeg har med meg to spennende gjester: Lars Tørresen, luttmaker i Bergen og luttenist Jadran Duncumb.Vi har en svært interessant og hyggelig prat om luttens historie, om renessanse- og barokklutter, om John Dowland og Silvius Leopold Weiss, om lutt-tabulatur fra Italia, Tyskland, Spania og Frankrike og mye mer.Luttmaker Lars Tørressen er utdannet arkitekt fra NTNU og lærte luttbygging på Birkagården Folkhøgskola i Sverige og av Tom H. Pettersen i Oslo. Lars har samlet seg kunnskap om klang, repertoar og spilleteknikk fra kurs i luttspill med J.Lindberg, H. Smith og R. Lislevand. Instrumentene lages for å imøtekomme profesjonelle musikeres krav og behov. Studier av originalinstrumenter i Europa og oppmåling ved Ringve Museum er en viktig kunnskapskilde. Instrumentene lages av gammelt treverk lagret opp mot 40 år. Siden 2017 er instrumentbygging hovedvirksomhet.Norsk-engelsk-kroatiske Jadran Duncumb er en av Europas ledende luttenister i dag. Han kombinerer en aktiv karriere som solist og kammermusiker på tidlige instrumenter, som har ført ham til konsertsaler som Wigmore Hall i London og Wiener Konzerthaus, med undervisning som førsteamanuensis i lutt ved Civica Scuola di Musica Claudio Abbado i Milano. Han er fast medlem av Barokkanerne – Norwegian Baroque Ensemble (som han også leder iblant), Repicco med Kinga Ujszaszi, Musica Alchemica med Lina Tur Bonet, Ensemble Diderot, og i duoer med Giulia Semenzato, Emil Duncumb og André Lislevand. Jadran har utgitt en rekke solo CDer på det franske plateselskapet Audax Records. Den siste, første volum av Bachs luttverker, ble tildelt den prestisjerike franske prisen Diapason D'Or. Fremtidige slipp inkluderer andre volum av Bach, et duoprogram med sopranen Giulia Semenzato på romantisk gitar for Alpha Classics, og det nyeste samarbeidet for Arcana med André Lislevand og Emil Duncumb, med musikk av Johann Sebastian Bach (1685–1750), Carl Philipp Emanuel Bach (1747–1788) og Carl Friedrich Abel (1723–1787). Denne gangen er det mine to gjester som har laget en fin og fyldig spilleliste for dere til dagens episode nr.7 - LUTT, den ligger allerede ute på Spotify og venter på dere, der kan dere lytte Lars' og Jadrans favorittmusikk for lutt.Søk den opp og kos deg med musikken!Dette er linken til spillelisten til denne episoden om LUTT:https://open.spotify.com/playlist/5dtoObGxsxIoi114JsusUg?si=209c40a8c60c461e&pt=95beca30ca63b3eb2027912b9a57b614(Denne linken virker kun innenfor Spotify! Hvis du lytter på Barokkpodden fra andre platformer enn Spotify, må du søke opp spillelisten separat!)*** Musikkeksemplene brukt i 7.episode av Barokkpodden, om LUTT:Silvius Leopold Weiss: Passacaglia i D-dur, SW 18/6 (Jadran Duncumb, lutt)John Dowland: Can she excuse, P. 42, The Right Honourable Robert, Earl of Essex His Galliard (Bor Zuljan)Johann Sebastian Bach: Works for lute: Fra Partita c-moll BWV 997: Double (Jadran Duncumb) ***Takk til Fond for Lyd og Bilde som støtter prosjektet Barokkpodden!Photo cred: Lars Bryngelsson

“It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events,” Teresa Knoop, MSN, RN, AOCN®, nurse consultant in Nashville, TN, told Jaime Weimer, MSN, RN, AGCNS-BC, AOCNS®, oncology clinical specialist at ONS, during a conversation about the latest updates and approvals in oncology pharmacology. You can earn free NCPD contact hours after listening to this episode and completing the evaluation linked below. Music Credit: “Fireflies and Stardust” by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0 Earn 1 contact hour of nursing continuing professional development (NCPD) by listening to the full recording and completing an evaluation at myoutcomes.ons.org by January 13, 2025. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of NCPD by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Participants will report an increase in knowledge related to the latest updates and approvals in oncology pharmacology. Episode Notes Complete this evaluation for free NCPD. Oncology Nursing Podcast Episode 126: Oncology Clinical Trials and Drug Development ONS Voice articles: S. Food and Drug Administration (FDA) updates Drug reference sheets Predictive and Diagnostic Biomarkers: Identifying Variants Helps Providers Tailor Cancer Surveillance Plans and Treatment Selection Help Patients Understand Biomarker Test Results and Clinical Trials Options Use ClinicalTrials.gov to Find the Right Cancer Research Studies for Your Patients ONS Biomarker Database ONS Genomics and Precision Oncology Learning Library ONS Immuno-Oncology Learning Library ONS Oral Anticancer Medication Learning Library ONS Biosimilars Learning Library ONS Seal of Approval Library Oral Chemotherapy Education Sheets Intravenous Cancer Treatment Education Sheets Clinical Journal of Oncology Nursing article: Clinical Trials: Nursing Roles During the Approval Process and Pharmacovigilance of Biosimilars FDA resources: Drug development and approval process Oncology/hematologic malignancies approval notifications Ongoing cancer accelerated approvals Verified clinical benefit cancer accelerated approvals Withdrawn cancer accelerated approvals Project Renewal Biosimilars review and approval Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.) Project Livin' Label Oncology Center of Excellence To discuss the information in this episode with other oncology nurses, visit the ONS Communities. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From Today's Episode “Full approval through the Center for Drug Evaluation and Research (CDER) and FDA means that those drugs have gone through the laboratory testing, human clinical trial testing, and very extensive clinical trials to make sure that they are effective and that the benefits of those drugs outweigh the risks.” TS 02:28 “In 1992, CDER established a new program that would help these drugs get expedited, particularly in life-threatening or serious diseases like cancer. So they established an accelerated approval pathway for these promising therapies. They were hoping to shorten that period of time, and a number of our cancer-fighting drugs have come onto the market through this accelerated approval pathway.” TS 04:29 “When a drug gets an FDA approval, whether it be accelerated or final, then typically they get approved for one, possibly two indications on that first approval. But there are clinical trials ongoing in other diseases and in other indications. So we will then see drugs—after those clinical trials are conducted—taken to CDER for approval for that new indication.” TS 24:02 “The exciting thing for our patients is that new indications often treat more advanced cancers in which you discover a biomarker and could give patients potential treatment options when other options may have been exhausted.” TS 27:43 “It's incumbent on us as nurses to stay informed about these newly approved drugs or new indications in drugs because we're the front line in helping these patients manage adverse events. Many of these drugs are designed so patients have to stay on them for extended periods of time, or at least they get the greatest benefit by staying on it for extended periods of time. Our patient education is key in helping patients do that.” TS 34:50 “In 2023, I think we will continue to see many new drugs that are approved. We will see new indications. I think particularly we will continue to see cellular therapy agents developed—we'll see them gain new indications. I would be willing to forecast that we're going to see more and more of specific immunomodulatory drugs or those antibody drug conjugates—all of those drugs that are designed to treat the cancer in a couple of different ways.” TS 37:29

Vi drar på jentetur med med dagens frokostgjest, Janne Formoe, som er hovedrolleinnehaver av den nye filmen Jentetur. Vi snakker om tiden før Spotify og brente CDer. Hva telles som juks på eksamen? Og kan robotene ta over skoleoppgaven din? Episoden kan inneholde målrettet reklame, basert på din IP-adresse, enhet og posisjon. Se smartpod.no/personvern for informasjon og dine valg om deling av data.

Bonjour et bienvenue sur Wine Challenge,Au programme de ce 71ème épisode, partons direction Avize, à la rencontre de Charlotte De Sousa :1:20' : Le Domaine De Sousa3:20' : Une philosophie de travail en biodynamie5:31' : Travailler entre frère et sœurs 7:10' : Trouver sa place sur le domaine10:45' : Vigneronne : une évidence ?12:47' : Son parcours de formation13:30' : Son expérience à l'OIV 14:47' : Le style De Sousa15:22' : Les vinifications au domaine16:45' : Quelques conseils18:00' : Être une femme en Champagne19:36' : Les Fa'Bulleuses de Champagne21:41' : Souvenirs de dégustations Belle écoute à toutes et à tous ! Crédit Photo : Champagne De SousaMerci au CDER de soutenir cet épisode :) Hébergé par Acast. Visitez acast.com/privacy pour plus d'informations.

Pink Sheet reporter and editors discuss another project to improve clinical trial diversity in the US, the Patent Trial and Appeal Board director review process, and the FDA promoting its head of controlled substance policy to deputy CDER director.

In April 2022, FDA issued new draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Subgroups in Clinical Trials. Because this guidance applies to all medical products, CDER, CBER, and CDRH all contributed, but this draft was led by Project Equity from FDA's Oncology Center of Excellence (OCE). “It is important that we be able to evaluate new therapies in the context of a diverse population that will use these medical products because the diseases for which these products are intended present in variable fashion across the population and because populations respond variably to medical products,” explains OCE Project Equity Lead Lola Fashoyin-Aje. “But we should reconsider the question regarding why diversity in clinical trials is important. Because the question really ought to be: What are we missing when trials are not diverse, when the study population in the clinical trial is not diverse? What are the missed opportunities for advancing science or advancing clinical medicine and, ultimately, for driving improvements in population outcomes?”

On This Episode, I was joined by Marla Phillips of Pathway for Patient Health. Marla and I discuss: Pathway for Patient Health Training the Next Generations - What students can do? Quality for the 21st Century Chief Quality Officer Forum FDA/Industry Collaborations How Xavier Health Came to be and the Future of Xavier Health Supply by Design The importance of doing things with purpose ------------------------------------------------------------- Pathway for Patient Health: Link Pathway for Patient Health Quality Science Program : Link Pathway for Patient Health Hiring Portal: Link Good Supply Practices/Supply by Design: Link 1 & Link 2 USP GOOD DISTRIBUTION PRACTICES—SUPPLY CHAIN INTEGRITY: Link Future of Xavier Health: Link ----------------------------------------------------------------- Marla Phillips PhD founded Pathway for Patient Health in 2018, and leads cultural, quality and supply chain initiatives with regulators and industry professionals for the betterment of patient health around the world. Phillips is a frequently invited speaker for major industry association conferences across the country each year, including the PDA/FDA Joint Regulatory Conference, AdvaMed Medtech Conference, Cold Chain Global Forum, USP, IPEC, and the FDA's own Association of Food and Drug Officials. In 2008, Phillips founded, Xavier Health at Xavier University. In this role, Phillips was asked to co-lead with FDA the CDRH Case for Quality metrics initiative from 2014-2016, which culminated in work that continues to support the Case for Quality program. She led the Good Supply Practices (GSP) initiative with the FDA Office of the Commissioner, CDER, pharmaceutical and medical device professionals, and suppliers, which has been published for global industry adoption. Additionally, Phillips founded the FDA/Xavier PharmaLink Conference, FDA/Xavier MedCon Conference, AI Summit and Combination Products Summit for global regulators and industry professionals. Phillips began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She has expertise in leading FDA inspections and readiness, quality, analytical testing and validation, supply chain, stability program management, process validation, manufacturing, and packaging operations. Phillips holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina – Chapel Hill.

This week we talked to Mari Margil, executive director at the Center for Democratic and Environmental Rights (CDER)! CDER works with governments, tribal nations, indigenous communities, civil society, and grassroots activists to protect the human right to a healthy environment and establish the rights of the environment itself – the rights of nature. This means securing the highest level of legal protection for humans and nature through the recognition of legal rights. Tune in to hear more about Mari's recent work and get an inside scoop on how CDER accomplishes these goals! Action Items: Follow @centerforenvironmentalrights Visit the Center for Democratic and Environmental Rights website: https://www.centerforenvironmentalrights.org/ Volunteer or intern at CDER! https://www.centerforenvironmentalrights.org/volunteer Want more ways to get involved or learn more about Eco Alarm? Follow us on Instagram, Facebook and LinkedIn @ecoalarmpodcast or check out our website: https://ecoalarmpodcast.com/ Interested in being a guest? Fill out our speaker form!

“There are good reasons to explore the use of artificial intelligence in pharmacovigilance. There are an increasing number of sources of drug safety information, and efficient screening, processing, or evaluation of them would benefit from accurate automated methods,” explains Gerald Dal Pan, Director, Office of Surveillance and Epidemiology (OSE), CDER. “First, there's the potential application of AI to the processing of case reports. Second, there's the potential application of AI for assessing causality in a case report. Third, we're exploring the use of AI in real-world data as part of the Sentinel Initiative.”

Etter å ha gitt ut noen album hver har vi blitt konfrontert med et litt tvilsomt fenomen som eksisterer på noen platformer hvis virke er å publisere anmeldelser av CDer. Vi snakker om våre erfaringer og hva man bør være obs på når man leser anmeldelser. Her er et eksempel vi gir på en god platform for å lese anmeldelser: https://acloserlisten.com

Les conditions climatiques de la récolte 2021 et la culture « Betteraves à sucre et ses déboires… » Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Pink Sheet reporters and editors discuss the implications of Aduhelm's updated indication, CDER's new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.

Parlons viticulture et principalement la prochaine récolte et les actions de sortie de crise avec Bertrand Trépo, responsable du marché viticole à CDER.

Les marchés agricoles avec Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

This week, Stacey is joined by FDA members Jennifer Maguire, Nandini Rakala, Alex Viehmann, Carla Lundi, and Lyle Canida. Stacey and the team from the FDA discuss the FDA announced innovative Quality Management Maturity Pilot Programs for Manufacturers of Drug Products and Active Pharmaceutical Ingredients. Results of this pilot program are intended to aid in the creation of a future rating system for drug makers, ranking the maturity of their quality management systems. Such a rating system and associated incentives for mature rating could lead to a renewed effort in risk management and provide motivation for companies to invest in their QRMs and the resources surrounding them.   Resources from this episode: Pharmaceutical Quality for the 21st-century report Quality Management Maturity Pilot Program as announced by the FDA   About Our Guests: CDR Lyle Canida CDR Lyle Canida is a PHS officer with 11 years at FDA. He has a Pharm.D., M.S. in Pharmacoepidemiology, and is Certified in Public Health. During his time with FDA, he has worked in various roles including IND and NDA reviews for clinical pharmacology genomics and overseeing post-market safety programs for drugs, foods, cosmetics, and dietary supplements. More recently, he has been with the Office of Pharmaceutical Quality helping to drive quality surveillance programs and other strategic initiatives. Jennifer Maguire, Ph.D. Dr. Jennifer Maguire is the Deputy Director of the Office of Quality Surveillance/OPQ/CDER/FDA. The office assesses intelligence throughout the product lifecycle to inform stakeholders about the state of pharmaceutical quality and uses data analytics to drive surveillance decisions. During her tenure at the agency, Dr. Maguire has contributed to multiple initiatives aimed at modernizing the regulation of pharmaceutical manufacturing and product quality including QbR, QbD, ICH Q12, Site Selection Model, Quality Metrics, and Quality Management Maturity. Dr. Maguire has a BS in Chemical Engineering from the University of Virginia and a Ph.D. in Industrial and Physical Pharmacy from Purdue University. Nandini Rakala, Ph.D. Dr. Nandini Rakala is a Data Scientist and Mathematician by background, currently working as a Visiting Associate within the Center for Drug Evaluation and Research at the U.S. FDA. Dr. Rakala earned her Ph.D. in Operations Research in May 2020, from the Department of Mathematical Sciences at Florida Tech, with her primary research work in Optimization and Machine Learning. She also holds a master's degree in Applied Mathematics and Computing from Manipal University, India; and a bachelor's degree in Mathematics Honors from the Sri Sathya Sai Institute of Higher Learning, India. During her past 2.5 years with the FDA, Dr. Rakala has worked on multidisciplinary regulatory research projects, employing her expertise in operations research, machine learning, natural language processing, programming skills, and knowledge of efficient quality management practices regarding pharmaceutical manufacturing. She is currently leading and/or serving as a subject matter expert on critical OPQ pilot programs such as the Quality Management Maturity, Quality Metrics, predictive modeling of PQS-CAPA effectiveness, prioritization of Field Alert Reports, drug shortage analysis, Report on the State of Pharmaceutical Quality, quality signal detection and topic modeling of post-market surveillance data. Dr. Rakala has had an opportunity to present her research work on several occasions at various conference seminars, and she is a recipient of numerous prestigious awards. In her personal free time, Nandini enjoys volunteering in community service activities, serving as a judge, playing tennis, writing, reading articles, and biographies. Alex Viehmann Alex Viehmann is currently the Director for the Division of Quality Intelligence II within the Office of Pharmaceutical Quality/Office of Quality Surveillance.  The Division performs post-market quality-based assessments of drug sites and products, enhanced by data integration and analytics tools developed in support of monitoring and improving drug quality, to inform congressional inquiries and data calls, future GMP inspections, enforcement decisions, and application assessment.  Alex joined the FDA in May 2008 as an Operations Research Analyst in the Policy and Standards Development staff within the Office of Pharmaceutical Sciences where he collaborated with stakeholders on developing policy and standards on sampling, test method evaluation, and statistical quality control.  He then transitioned to the Science and Research staff where he provided statistical support for CMC review, GMP inspections, and enforcement actions.  Since joining OQS in 2015, Alex has guided the development of OPQ's Quality Metrics program, CDER/ORA's New Inspection Protocol Project (NIPP), and OQS's analytics and modeling program.  He is also actively engaged in implementing Pharmaceutical Quality System (PQS) assessments in support of Established Conditions and the Site Engagement Program (SEP).  He currently serves as the Regulatory Chair for ICH Q9 and as a member of the PIC/S Expert Circle Working Group on Quality Risk Management. Alex received his bachelor's degree in economics from the University of Maryland at College Park.  Carla Lundi Carla J. Lundi has been with the FDA as a Consumer Safety Officer since 2002, working initially with the Office of Regulatory Affairs in the Los Angeles District. While with ORA she was a Drug Specialist, member of the Pharmaceutical Inspectorate, and member of the Drug Foreign Inspection Cadre specializing in sterile drug manufacturing inspections. In 2016 she transferred to CDER's Office of Pharmaceutical Quality, Office of Quality Surveillance working primarily on monitoring drug product and manufacturing site quality-related signals for mitigation of urgent quality issues; evaluation and reporting of data related to pharmaceutical quality and drug availability for internal and external customers; collaborating with business partners to determine data to be collected from sites through onsite inspections or other innovative approaches; and drug training collaboration and development. Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com. 

The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. To expedite the evaluation of new drugs and review of marketing applications for drugs addressing unmet medical needs for patients with serious or life-threatening conditions, the FDA has established four expedited programs: Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval. This episode examines FDA Expedited Programs with CDER's Senior Regulatory Expedited Programs Manager, Miranda Raggio.

Pink Sheet reporters and editors discuss the end of stem cell clinic enforcement discretion, the US FDA’s projection that inspections will return to normal levels in FY 2022, and improved hiring in CDER.

Parlons viticulture et principalement des défis de la Champagne après la crise Covid-19 avec Bertrand Trépo, responsable du marché viticole à CDER.

Dans notre émission de ce jour, nous présenterons les outils et bénéfices du numérique en agriculture avec Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Dr. Dan Rubin, statistician, Division of Biometrics IV in CDER's Office of Biostatistics sharing some thoughts draft guidance Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics

Frøydis Grorud har blitt folkeeie gjennom sine 20 år i Beat for Beat i NRK. Hun turnerer mye med ulike konstellasjoner og har gitt ut en lang rekke CDer. Frøydis er en utrolig positiv og hyggelig person som gir av seg selv gjennom musikken - om det er i Beat for Beat, på et eldrehjem eller på Slottet. I denne samtalen snakker vi om hennes oppvekst i Skien og hvordan musikken veldig tidlig fylte både tid og oppmerksomhet. Musikken er et språk som kan formidle på et nivå der ord kommer til kort. Det er fantastisk å møte folk en ikke kan snakke med, men som føles som gamle kjente når vi begynner å spille sammen, sier Frøydis.Ypsilonsamtaler er en podkast av og med Ivar Flaten fra Kirkelig Dialogsenter Drammen. Ypsilon er den ikoniske gangbroen over Drammenselva. Drammen er elveby og en by for brobyggere. Som daglig leder og dialogprest inviterer Ivar mennesker til samtaler der kulturmøter, brobygging og samfunnsliv er tema. De inviterte har bidratt - og bidrar til at verden blir et bedre sted gjennom arbeidsliv, frivillig innsats og samfunnsengasjement på ulike måter.Drammen kommune har omtrent 100.000 innbyggere med røtter i over 150 nasjoner. Her lever mennesker med veldig mange ulike historier, kulturelle referanser og religiøse tradisjoner. Gjennom 15 års prestetjeneste og like lang dialogpraksis, har Ivar snakket med svært mange mennesker og fått et stort nettverk.Kulturmøtene i internasjonale Drammen er rammen for samtaler med livshistorier, kunnskap om forskjellige tenkemåter og levemåter - og mye materiale til refleksjon. Kort sagt vil Ypsilonsamtaler gi deg muligheten til å bli litt mer kjent med mange fascinerende mennesker.En ny episode av Ypsilonsamtaler kommer hver torsdag. Vi er takknemlige for innspill og forslag! Send oss gjerne en e-post!Vignettmusikk: Ole Jørn MyklebustLogo: Svanhild RohdinTeknisk produksjon: Ivar Flaten See acast.com/privacy for privacy and opt-out information.

Parlons viticulture et principalement du gel et de la réserve individuelle en champagne avec Bertrand Trépo, responsable du marché viticole à CDER.

Parlons viticulture et principalement du gel et de la réserve individuelle en champagne avec Bertrand Trépo, responsable du marché viticole à CDER.

Parlons viticulture et principalement du gel et de la réserve individuelle en champagne avec Bertrand Trépo, responsable du marché viticole à CDER.

Parlons viticulture et principalement du gel et de la réserve individuelle en champagne avec Bertrand Trépo, responsable du marché viticole à CDER.

Réforme de la Politique Agricole Commune (PAC) : quels enjeux pour la France ? Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Réforme de la Politique Agricole Commune (PAC) : quels enjeux pour la France ? Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Réforme de la Politique Agricole Commune (PAC) : quels enjeux pour la France ? Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Réforme de la Politique Agricole Commune (PAC) : quels enjeux pour la France ? Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.

Pink Sheet reporters and editors discuss the response to the rare blood clots seen with Janssen’s COVID-19 vaccine, the US FDA’s new virtual facility inspection guidance, and the new permanent director of the Center for Drug Evaluation and Research.

Vendre son champagne malgré la COVID19 avec Bertrand Trépo, responsable du marché viticole à CDER, et Hubert Cartel.

Vendre son champagne malgré la COVID19 avec Bertrand Trépo, responsable du marché viticole à CDER, et Hubert Cartel.

Vendre son champagne malgré la COVID19 avec Bertrand Trépo, responsable du marché viticole à CDER, et Hubert Cartel.

Vendre son champagne malgré la COVID19 avec Bertrand Trépo, responsable du marché viticole à CDER, et Hubert Cartel.

Le machinisme et son développement avec Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.