최고 Fda Regulation 팟캐스트 (2024)

1
Patient Advocates Could Cost You Millions 2:42

1d ago2:42

2:42

Patient Advocates play a crucial role in the pharmaceutical industry, especially in clinical research. They serve as the voice of patients, ensuring their needs and concerns are addressed throughout the drug development process. Here's a simple breakdown of their contributions and when their involvement might not be ideal. Why Are Patient Advocates…

1
Medical Device News, October 2024 Regulatory Update

4d ago

—

Medboard: https://www.medboard.com/ EUROPE TEAM NB – Code of Conduct for NB – Version 5: https://www.team-nb.org/wp-content/uploads/2024/09/PressRelease-CoC-20240916.pdf TEAM NB – IVDR Transition – Transition to the implementation of Class D oversight by EURLs: https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-ClassD-20241001.pdf MDCG…

1
Managing Risks in Life Sciences Mergers and Acquisitions 5:55

4d ago5:55

5:55

In this episode, we discuss key risks a life sciences company should consider during an acquisition with Kenneth White. We also explore the role of insurers in managing these risks. Support the show저자 Darshan Kulkarni

1
How do pharmacists’ read doctors’ cursive letters? 1:30

6d ago1:30

1:30

Pharmacists often use a process of elimination to decipher doctors' handwritten prescriptions. Pharmacists rely on clues like drug names and doses, this method isn’t foolproof. If the handwriting is unclear, identifying the correct medication can be challenging, leading to potential errors. The shift to electronic prescribing has improved accuracy …

1
🔒 AI Data Ownership in Pharma 4:59

9d ago4:59

4:59

Subscriber-only episode we explore how AI is transforming content generation in the pharmaceutical industry, particularly in marketing, sales, and medical engagements. While AI presents groundbreaking opportunities, it also raises critical challenges, notably concerning data ownership and compliance. A significant issue is the lack of clarity aroun…

1
How to select the best plastic for your Medical Device?

11d ago

—

In this episode, Lucas Pianegonda will help us to select the right material for your medical device and also answer questions that you maybe would love to hear his answer. We will also talk about sustainability for plastics. So check this. Who is Lucas Pianegonda? Lucas Pianegonda is an expert for medical grade plastics, material testing and materi…

1
Food Safety Culture and Sustainability: Insights from Steven Foster 21:39

12d ago21:39

21:39

Join Lydia Adams on Food Tech Talk as she interviews Steven Foster, a seasoned expert in food safety and quality assurance with over 30 years of experience in the food industry. Currently serving as the VP of Food Safety and Quality at Wholesale Produce Supply, Steven shares his journey and the defining moments that shaped his approach to food safe…

1
🔒 Role of Tech Transfer in Clinical trial agreements 7:30

13d ago7:30

7:30

Subscriber-only episode In this episode, we are joined by Istvan Fekete to have a discussion over tech transfer offices, IP, and more. The video explains what tech transfer offices are, their significance in the research ecosystem, and why they might be the best place to negotiate equity stakes in intellectual property (IP) created by investigators…

1
Pharma – The Last Word – Breaking Barriers: The FDA’s Evolving Approach to Biosimilars and Interchangeability 22:28

17d ago22:28

22:28

In this episode, host Phil Katz sits down with Deborah Cho, to discuss the evolving landscape of biosimilarity and interchangeability. They dive into the FDA's changing approach, highlighting the shift towards treating biosimilars and interchangeable biosimilars as a single category. Deborah explains how advancements in technology and experience ha…

1
UK vs EU vs US – How to switch to another region easily?

20d ago

—

In this episode, Claire Dyson will give us the recipe to launch correctly your Medical Device when you go abroad and for that we will take the example of EU and US. Who is Claire Dyson? Who is Claire Dyson? Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery …

1
Why are medicine names so complicated? 2:09

21d ago2:09

2:09

Darshan was asked to explain why drug names can be so complicated, and the answer lies in the fact that each drug typically has at least three distinct names. First, there’s the chemical name, which is a technical identifier describing the drug’s molecular structure—these names are often long and complex, like “acetylsalicylic acid,” and are more f…

1
Fixing Congruency Reviews in 8 Minutes 8:36

22d ago8:36

8:36

In this episode, Istvan Fekete joins us to discuss the intricacies of Congruency Reviews. We will explore the common mistakes individuals may encounter during these reviews and examine effective strategies for handling these errors. Additionally, we will delve into the processes that can be implemented to mitigate risks associated with congruency r…

1
The Dark Side of Med Device Kickbacks 4:45

26d ago4:45

4:45

Today, we're discussing a critical issue for pharmaceutical and medical device marketers – promotional compliance. Overview of the Innovasis Settlement: Innovasis Inc. recently settled a $12 million case for alleged kickback schemes to doctors. This highlights the importance of promotional compliance. Allegations Against Innovasis: From Jan. 1, 201…

1
Chemistry to Quality: From Dr. Stephen Sims' Journey in Food Safety 27:43

27d ago27:43

27:43

In this episode of Food Tech Talk, Lydia Adams sits down with Dr. Stephen Sims, a distinguished food safety and quality assurance expert. With a background in chemistry and extensive experience in the food industry, Dr. Sims offers unique insights into the world of food safety auditing and quality management. Dr. Sims takes us through his journey f…

1
How to do a PMCF Literature Search for Medical Devices?

27d ago

—

In this episode, Cesare Magri will try to improve our skills on PMCF literature search. We will investigate on the misconceptions and what people should make to do it right. Who is Cesare Magri? Cesare Magri is the founder and CEO of 4BetterDevices GmbH. He and his team of medical doctors and biostatisticians assist medical device and in-vitro diag…

1
Which Hair Loss Treatment Is Right for You? 2:29

29d ago2:29

2:29

Darshan addresses common questions about potential treatments for hair loss. He provides insights based on his expertise as both a pharmacist and an FDA regulatory lawyer. Darshan explains that FDA-approved treatments for hair loss include minoxidil and finasteride. Minoxidil, originally a blood pressure medication, can lower blood pressure and has…

1
Medical Device News, Septembre 2024 Regulatory Update

1M ago

—

EU e-IFU for medical devices – Consultation ongoing: https://ec.europa.eu/eusurvey/runner/Survey_eIFUs_medicaldevices_2024?surveylanguage=EN MDR Transition period – Visual timeline: https://health.ec.europa.eu/document/download/06bb3982-dc01-46aa-95af-d8833c9fcb21_en?filename=timeline_mdr_en.pdf Implementing Act IVDR Common specifiaction – Consulta…

1
Analyzing the Publication Rights Clause in CTAs 1:49

1M ago1:49

1:49

Today's discussion revolves around the legal clauses found in clinical trials, with a focus on Article 8, the Publication Rights Clause. The following points are discussed: Unrestricted Rights: The clause prov ides the Site with unrestricted rights to publish all trial data. This is excessive and could jeopardize the Sponsor's control over the inte…

1
What Really Starts Pharmacy Investigations? 1:52

1M ago1:52

1:52

We discuss the seven ways pharmacy investigations can begin: 1. Data Analysis: Agencies like the DEA and DOJ monitor prescription data for unusual patterns, such as excessive dispensing of certain drugs. 2. Tips: Anonymous reports from the public or industry insiders alert authorities to suspicious activities. 3. Whistleblowers: Individuals within …

1
How to use AI GPT for your Quality and Regulatory work?

1M ago

—

In this episode, Martin King will share with us his practice of AI in the context of Quality and Regulatory affairs for medical devices. This will explain to you some best practices to maintain to avoid some pitfalls. Who is Martin King? Martin Cranston King, a Swiss consultant working with medical devices, in vitro diagnostics (IVD), and pharmaceu…

1
Integrating Joy and Nutrition: Strategies for Dieticians from Chef Phoebe Lapine 18:25

1M ago18:25

18:25

Join Lydia Adams as she interviews Phoebe Lapine, a chef, wellness advocate, and author of "The Wellness Project" and "Carbivore." Phoebe shares her unique journey from culinary expert to health-conscious cookbook creator, offering a fresh perspective on the intersection of delicious food and nutritious eating. Throughout the discussion, Phoebe del…

1
How to go from Zero to Hero in Medical Devices?

2M ago

—

In this episode, Stephen O’Rourke that was not working within the Medical Device industry will share with us is journey from Zero knowledge in the field to running projects. Listen to his journey in case you are also willing to breakthrough the medical device field. Who is Stephen O’Rourke? Stephen O’Rourke, based in Berlin, Germany, is a seasoned …

1
The Legal Battles Taking Shape in the Clash Over Internet Content 39:52

2M ago39:52

39:52

A federal law known as Section 230 has provided a powerful legal shield for internet companies for nearly three decades. Designed to “promote the internet,” it protects platforms from civil liability for content posted to their sites by third parties. But the measure is inspiring lawsuits from plaintiffs who say it allows internet companies to esca…

1
🔒 Is your clinical trial AI racist? 4:52

2M ago4:52

4:52

Subscriber-only episode We dive into the critical issue of racial bias in AI, highlighted by a recent Yale study focusing on ChatGPT. This has significant implications for clinical research sponsors, sites, and principal investigators. We also explore the FDA's perspective on AI in clinical trials, presented by Dr. Elzarrad. Overview of the Yale St…

1
FSMA 204 and the Future of Food Safety: Insights from Kroger's Catherine Cosby 29:50

2M ago29:50

29:50

In this insightful episode of Food Tech Talk, Lydia Adams interviews Catherine Cosby, Director of Food Safety and Regulatory Compliance at Kroger. With over 15 years of experience in the food industry, Catherine shares her journey and expertise in food safety. The conversation centers on FSMA 204 and its implications for the food industry, with Cat…

1
Manage the Transfer/Renewal/Surveillance/Change of your CE certificate

2M ago

—

In this episode, I have invited Ralf Gansel to help us understand the process for Certification of your product and what is the lifecycle for it. We’ll discuss about Transfer or certificates, or notification of changes or why there is a renewal and not continuous surveillance… Who is Ralf Gansel? With over a decade of experience in the medical heal…

1
Gillian Schauer, Jessice Burgess and an Outlook on Hemp from State Regulators 25:16

2M ago25:16

25:16

Jonathan Miller interviews Gillian Schauer, Executive Director of the Cannabis Regulators Association (CANNRA), and Jessica Burgess, Deputy General Counsel of the Massachusetts Department of Agricultural Resources, about hemp policy from the purview of state regulators. If you have questions about the episode or ideas for Hemp related topics, email…

1
Another Pharmacy owner Jailed in Fraud Case 3:04

2M ago3:04

3:04

Today we're diving into a critical issue that has shaken the pharmacy world. Recently, a pharmacy owner was sentenced for paying illegal kickbacks and engaging in a money laundering conspiracy. This case has significant implications for promotional compliance within the pharmacy industry, and we're here to explore them in detail. In a landmark case…

1
How to use Harmonized Standards for Medical Devices?

2M ago

—

Medical Devices should follow some standards but if these standards are harmonized this brings them to another level. This will be a great discussion with Beat Keller on how to use them correctly. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market …

1
Navigating FDA's clinical trial expectations after approval 3:25

2M ago3:25

3:25

Today, we're diving into the FDA's Fiscal Year 2022 report on postmarketing requirements (PMRs) and postmarketing commitments (PMCs). PMRs are mandatory studies required by the FDA after a drug's approval, focusing on real-world data for long-term safety and effectiveness. Think of them as an extension of the initial research phase, but in a real-w…

1
Legal Minute: Do dietary supplements interact with drugs? 0:59

2M ago0:59

0:59

Do dietary supplements interact with drugs? Many people think only prescription drugs can cause interactions, but dietary supplements can too. From an FDA perspective, a drug is defined by its claims and indications. Some supplements make drug-like claims and can interact with medications. Common examples include grapefruit juice and vitamin K, whi…

1
How Expert Pharma Marketers Navigate Privacy 1:26

2M ago1:26

1:26

In today's consumer landscape, privacy concerns reign supreme. Pharmaceutical and medical device manufacturers must prioritize meeting the expectations of this privacy-conscious generation. This begins with three key measures: 1. Consent Management: Clear communication about data usage is essential, aligning with regulations like CCPA and GDPR. See…

1
Food Science Insights with Rachel Zemser of A La Carte Connections 32:44

2M ago32:44

32:44

In this episode of Food Tech Talk, Lydia Adams interviews Rachel Zemser, a food science industry consultant with nearly three decades of experience. Rachel, the Founder of A La Carte Connections, shares her journey in the food industry and her passion for food science, which was sparked by her international upbringing and exposure to diverse food c…

1
IVDR Class D – Lesson learned from Notified Bodies

2M ago

—

The EU IVDR is in place and we will focus on this episode on Class D devices. Andreas Stange will explain to us what TÜV SÜD learned from the 100th class D certificates they issued. We will also review the timeline for IVDR and explain the next deadline which is in October. So be aware of it now. Who is Andreas Stange? Dr. Andreas F. Stange is a vi…

1
Robert Hoban and the "War" Between Hemp and Marijuana 16:22

2M ago16:22

16:22

Jonathan Miller interviews Robert Hoban, a leading national attorney in the hemp and cannabis space, about the brewing policy conflict emerging between the hemp industry and its cousins in the cannabis industry. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questi…

1
Hiring New Employees in PharmaTech Companies 22:05

2M ago22:05

22:05

Edye Edens, a consultant and attorney with a background in regulatory affairs, shared insights into her unexpected yet exciting role at Weave, a rapidly growing startup specializing in AI-driven solutions for regulatory content creation. Edye discussed her journey from freelance consultancy to joining Weave, highlighting the unique challenges and o…

1
How Drug and Device Companies Can Tackle Internet Misinformation 18:12

2M ago18:12

18:12

On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices …

1
EU MDR Major update: Interruption or Discontinuation of supply!

3M ago

—

The EU MDR is still not stable. There are still updates ongoing so stay tuned and listen to Erik Vollebregt explaining the Article 10a that will be integrated to the EU MDR where medical device manufacturers have to inform about interruption of supply. So what will be the requirements and what should you do. Listen to it to know more. Who is Erik V…

1
3 Hidden Dangers of Telehealth Marketing 1:51

3M ago1:51

1:51

In this episode, we discuss how drug and device manufacturers may seem to collaborate with telemedicine companies to market products and ensure patient needs are met conveniently. However, there are three major concerns: 1. Ignoring Pharma Laws: Telehealth companies might not adhere to pharma marketing laws and could act as agents for pharma due to…

1
Why a food lawyer would stop your restaurant’s marketing? 1:38

3M ago1:38

1:38

Today, we're tackling a critical issue for restaurants and food marketers: promotional compliance and the risks of misbranding, as highlighted by a recent case in Biloxi. Mary Mahoney's Old French House Restaurant and its co-owner, Anthony Charles Savanovich, recently pled guilty to conspiracy and misbranding seafood. Over six years, they sold over…

1
Legal Minute: Why are there chemo drug shortages? 0:52

3M ago0:52

0:52

We discuss how the shortage of chemotherapy drugs stems from economic challenges faced by generic drug manufacturers. Many cannot afford to produce these drugs due to low profitability. Factors include factory shutdowns for quality issues, a complex global supply chain, and older generic drugs being unprofitable to produce. Government pressure on p…

1
Advancing Food Safety and Sustainability: Insights from Leanne Singleton of FoodSure Australia 33:28

3M ago33:28

33:28

In this episode of Food Tech Talk, Lydia Adams interviews Leanne Singleton, a food industry expert with over two decades of experience. Currently the Principal Food Safety, Food Waste Specialist at FoodSure Australia, Leanne discusses the significant changes in food safety systems over the past 20 years, highlighting the shift from reactive inspect…

1
How to register your Medical Device in the UAE?

3M ago

—

Registration of Medical Devices can be complicated. But here we will share with you the process for the United Arab Emirate where the famous city of Dubai is located. Ahmed Hendawy from Registitute is helping us to understand this process and he confirms that it is really simple. So no way that you miss this. Who is Ahmed Hendawy? Ahmed is an estee…

1
Are Pharma Giants Ignoring Clinical Trial Site Issues? 30:10

3M ago30:10

30:10

In this episode, Daniel Fox discusses the key challenges faced by research sites, including trust issues, payment delays, and operational setbacks. He emphasizes initiatives like the "Open Mic" policy for anonymous feedback and the grassroots movement Save Our Sites (SOS). Dr. Fox also explores issues with decentralized clinical trials, advocates f…

1
Rod Kight and Regulation of Adult Cannabinoids 19:06

3M ago19:06

19:06

Jonathan Miller interviews Rod Kight, one of the nation's leading hemp attorneys, on the optimal path forward for the regulation of adult hemp cannabinoid products. If you have questions about the episode or ideas for Hemp related topics, email us at hemplegallyspeaking@fbtlaw.com. Hemp Industry questions covered in the episode: How did the adult c…

1
Why Adverse Events Go Unreported in Clinical Trials 1:51

3M ago1:51

1:51

In clinical trials, reporting adverse events and protocol deviations is crucial for patient safety and trial integrity. However, some sites may hesitate to report due to concerns about trial disruption, revenue loss, and increased scrutiny. This reluctance can lead to serious consequences, as seen in cases where significant events like hives, disru…

1
The Growing Epidemic of Elderly Abuse 12:35

3M ago12:35

12:35

The number of senior citizens is growing rapidly; individuals aged 65 and older increased from 39.6 million in 2009 to 54.1 million in 2019 (a 36% increase) and is projected to reach 94.7 million by 2060. However, over the last few years, the usual respect and care of our aging population is decaying into a growing incidence of neglect and abuse. P…

1
Who are patient advocates? 3:53

3M ago3:53

3:53

In this episode, we delved into the pivotal role of patient advocates within the pharmaceutical industry. Patient advocates are champions who ensure that patients' voices are not only heard but also central to decisions affecting their health. They play a crucial role in various aspects: Firstly, patient advocates are instrumental in representing t…

1
EU Battery Regulation – How to be ready?

3M ago

—

More and more regulations have to be applied parallel to the EU MDR and the one of the EU Battery Regulation is not an exception. Erik Vollebregt from Axon Lawyers will explain these additional requirements to us. He will also confirm that Notified Bodies can ask you questions about it and finally, he will share some key timelines for its implement…

1
Drafting the Future: Unpacking the FDA's Clinical Trial Diversity Action Plan 14:03

3M ago14:03

14:03

In the third part of our clinical trial diversity series, Deborah Cho, Stephanie Agu, and Ashley Grey dissect FDA's new draft guidance on Diversity Action Plans for clinical trials, released on June 28, 2024. Discover what this pivotal document means for clinical trial design and conduct, and its implications for drug and biologic sponsors. Tune in…

들어볼 가치가 있는 팟캐스트

Fda Regulation 팟 캐스트

들어볼 가치가 있는 팟캐스트

빠른 참조 가이드