Digitalisation is a hot topic in consumer health, and “digital health” covers a broad spectrum of applications, from wellness apps to virtual reality therapeutics. In this episode, HBW Insight speaks to regulatory expert Jamie Hatzel to get some clarity on “software as a medical device” – a subset of medical device regulatory frameworks within which many digital health applications are classified. In the first part of a two-part podcast, Hatzel briefly outlines the UK and EU regulatory approaches to SaMDs, before we discuss specific examples such as symptom trackers, wellness apps and digital therapeutics. In the second part, we talk about artificial intelligence, how incoming AI regulations impact SaMDs and whether OTC firms should take the plunge into this highly regulated but nevertheless very exciting space.

What's ‘Software As A Medical Device’ And How Is It Regulated In The EU? With Bristows’ Jamie Hatzel

In this podcast, Janelle Hart, Managing Editor at Citeline, teams up with industry experts Mai Yee Mishir, Senior Director of Global Regulatory Affairs, and Sally-Ann McDowell, Senior Director of Clinical Development Strategy at Advanced Clinical, to discuss the vital role of HRQoL in clinical trials. Listen now.

Health-Related Quality of Life Considerations In Clinical Trials

Pink Sheet reporter and editors discuss the potential fallout if the US FDA’s rare pediatric disease priority review voucher program is allowed to sunset on 1 October (:30), as well as an upcoming agency advisory committee meeting on potentially banning compounding of the now withdrawn pre-term birth prevention drug Makena (18:39).

More On These Topics From The Pink Sheet

US FDA’s Rare Pediatric Voucher Program Faces Tight Deadline For Reauthorization: https://pink.citeline.com/PS155196/US-FDAs-Rare-Pediatric-Voucher-Program-Faces-Tight-Deadline-For-Reauthorization 

Ipsen Outpaces Market With Lucrative Priority Review Voucher Deal: https://pink.citeline.com/PS155197/Ipsen-Outpaces-Market-With-Lucrative-Priority-Review-Voucher-Deal

Drug Fix: Pediatric Rare Disease PRV Deadline Approaches, Potential Makena Compounding Ban

Audio roundup of selected biopharma industry content from Scrip over the business week ended 6 September 2024. In this episode: J&J interested in differentiated obesity assets; Kerendia hits in heart failure; strong HERCULES data keep Sanofi’s MS plans alive; WCLC preview; and Mankind sets eyes on 5x growth.
https://scrip.citeline.com/SC150865/Quick-Listen-Scrips-Five-MustKnow-Things

Playlist: soundcloud.com/citelinesounds/sets/scrips-five-must-know-things

Scrip's Five Must-Know Things - 9 September 2024

호아킨 두아토 존슨앤존슨 대표가 모건스탠리 헬스케어 컨퍼런스에서 발표한 내용입니다.
https://scrip.citeline.com/SC150846/JJ-Interested-In-Differentiated-Obesity-Assets

Playlist: https://soundcloud.com/citelinesounds/sets/korean-language-biopharma-mini

J&J, '차별화된' 비만 자산에 관심있어 (Korean-language podcast)

世界の製薬ビジネスを伝える「Scrip」と、各国で変化する製薬関連の規制に特化した「Pink Sheet」。普段は英語で発信する2つのオンラインメディアから、今注目の話題を日本語で短くまとめてお届けします。
今回取り上げた記事はこちら
「Multiple Chinese Firms Expand Global Phase III Trials To Japan（邦訳：中国企業、第三相グローバル治験の地域を続々と日本に拡大）」
 https://scrip.citeline.com/SC150842/Multiple-Chinese-Firms-Expand-Global-Phase-III-Trials-To-Japan

Playlist: https://soundcloud.com/citelinesounds/sets/japanese-language-mini

【3分で解説  世界のファーマ】第21回 中国企業 日本で続々治験開始へ (Japanese-language podcast)

Generics Bulletin's editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events on the calendar over the next few months and beyond.

The Generics Bulletin Podcast: Recent And Upcoming Industry Events

Emma and Summer meet with oncology analyst Flora to discuss the therapeutic potential of exploring the tumor microenvironment.

Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

Spotify Podcasts - https://open.spotify.com/show/3DTc3eIh4xI6pVOd6DdO67​

September 2024 Datamonitor Healthcare Podcast: Diving into the TME

Introduction: Pink Sheet reporter and editor discuss the FDA’s latest advertising enforcement letter, which targeted a migraine treatment TV commercial featuring Serena Williams, and its impact on drug promotion (:36), as well as the now growing list of legal cases targeting agency decisions with Chevron deference overturned (13:32).

More On These Topics From The Pink Sheet

Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie: https://pink.citeline.com/PS155225/Celebs-Bring-Extra-Scrutiny-To-Advertisements-US-FDA-Tells-AbbVie 

Lilly Challenges US FDA Classification Of Obesity Drug Retatrutide, Citing Chevron Overturn: https://pink.citeline.com/PS155205/Lilly-Challenges-US-FDA-Classification-Of-Obesity-Drug-Retatrutide-Citing-Chevron-Overturn 

Life After Chevron: US Supreme Court Ruling Cited In FDA Exclusivity Decision Challenges: https://pink.citeline.com/PS155211/Life-After-Chevron-US-Supreme-Court-Ruling-Cited-In-FDA-Exclusivity-Decision-Challenges 

US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide: https://pink.citeline.com/PS155226/US-FDA-Biologics-Designation-As-Price-Protection-Lilly-Charts-New-Course-With-Retatrutide

Drug Fix: US FDA Worries About Celebs Endorsing Drugs, Post-Chevron Lawsuits Emerging

In this episode, HBW chats with Neil D’Souza, CEO of Makersite GmbH, a Stuttgart, Germany-based data software company that offers product data management tools that enable personal care firms to manage product sustainability, cost and compliance. D’Souza provides his take on what defines sustainable product development and how companies can use technologies such as “digital twin” product models to analyze and improve sustainability, while developing products at a faster pace.

Over the Counter: Data Tech CEO On Digital Tools Driving Faster, More Sustainable Personal Care

Emma Wille chats with oncology team director Dana Gheorghe, PhD, about the resurgence of radiopharmaceutical therapies in oncology.

Other platforms (in addition to SoundCloud):​

Apple Podcasts -   https://podcasts.apple.com/us/podcast/pharma-intelligence-podcasts/id923189836​

Google Podcasts - https://podcasts.google.com/feed/aHR0cHM6Ly9mZWVkcy5zb3VuZGNsb3VkLmNvbS91c2Vycy9zb3VuZGNsb3VkOnVzZXJzOjEwNjU1NDkyOC9zb3VuZHMucnNz​

​TuneIn - https://tunein.com/podcasts/Business--Economics-Podcasts/Pharma-Intelligence-Podcasts-p1140128/​

September 2024 Datamonitor Healthcare Podcast: Radiopharmaceutical Usage is Heating Up

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

What's ‘Software As A Medical Device’ And How Is It Regulated In The EU? With Bristows’ Jamie Hatzel

Citeline

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