The European Commission has published the finalized text of the Artificial Intelligence Act which establishes a legal framework to promote the uptake of “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices and other products. The Act also sets harmonized rules for placing products on the market, and is the world’s first comprehensive AI law, according to the European Parliament. Joanne Eglovitch reports in Regulatory Focus ✍️ 📢 https://bit.ly/4f62GGZ
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 172,258 followers
Driving Regulatory Excellence
About us
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Founded in 1976, RAPS helped establish the regulatory profession and continues to actively support the professional and lead the profession as a neutral, non-lobbying nonprofit organization. RAPS offers education and training, professional standards, publications, research, knowledge sharing, networking, career development opportunities and other valuable resources, including Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. RAPS is headquartered in suburban Washington, DC, with offices in Europe and Asia, and chapters and affiliates worldwide.
- Website
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https://www.raps.org
External link for Regulatory Affairs Professionals Society (RAPS)
- Industry
- Non-profit Organizations
- Company size
- 51-200 employees
- Headquarters
- Rockville, MD
- Type
- Nonprofit
- Founded
- 1976
- Specialties
- regulatory profession, regulatory affairs, professional association, medical devices, pharmaceuticals, and biotechnology
Locations
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Primary
Get directions
5635 Fishers Lane
Suite 400
Rockville, MD 20852, US
Employees at Regulatory Affairs Professionals Society (RAPS)
Updates
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Packed with expert insights and actionable strategies, the eBook "Best Practices for Medical Device Label Management Compliance" is perfect for regulatory professionals responsible for updating and maintaining medical device labels. Sponsored content from Schlafender Hase. Download your free copy: https://bit.ly/4cqbQMM
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Share your expertise in regulatory intelligence! We're looking for presenters for the RAPS Regulatory Intelligence Conference. Presenting at this conference is a chance to share your insights with the regulatory community in an environment dedicated to advanced learning. At the RAPS Regulatory Intelligence Conference, presenters contribute insights that lead to interactive discussions with other experienced professionals that ultimately benefit the profession. Learn more: https://bit.ly/3zGVq4i
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Join us in 2 days to get an inside look at the power of automation for clinical labeling! Are you struggling with manual workflows, vendor dependencies, lengthy review and approval processes, translation expenses, and tedious repeat work? This webcast brings together leaders in clinical labeling from Glemser to discuss common challenges and their solutions. Ray Glemser, PhD, Pawan Gandhi, and Geetha Muthuswami will share how the practical integration of traditional practices and modern technologies are accelerating the clinical labeling process. Expand your expertise and sign up today 📆: https://bit.ly/3VSTiz4
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RAPS staff gathered at our HQ to plan, break down silos and ensure that we're providing the best possible resources to help regulatory professionals learn and grow. But we also made a little time to: -Welcome our new staff members -Celebrate our successes -Brainstorm new ideas -Give back to our local community at Nourish Now We've got a great second half of the year planned, and we can't wait to share more with all of you!
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Medical device claims can be challenging for regulatory professionals to navigate, as there is little published to identify the boundaries. At this free webcast, Michelle Lott, RAC will help attendees understand the nuances of FDA and FTC's roles in the oversight of companies making inappropriate claims. You'll explore the available regulations, case studies of warning letters related to claims, and how you can avoid the FDA’s adulterated and misbranded "label." Plus, you'll learn through real-life examples where inappropriate claims resulted in action by the FDA and FTC. 📆 Save your seat today: https://bit.ly/3xPerkt
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Between 1995 and 2014, a majority of new drugs and medicines approved by the FDA recouped the average cost of drug development through net discounted sales within a decade of their approval, according to results from a recent retrospective study. “For these products, patents, data protection, and other regulatory exclusivities appear to provide brand-name drug makers with generous market protection,” Olivier J. Wouters, assistant professor of health policy at the London School of Economics and Political Science, and colleagues wrote. Jeff Craven reports for Regulatory Focus: https://bit.ly/3S8CMsi
Study: Most drug products recouped development costs within a decade of approval
raps.org
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If you work in regulatory, this is an event you won't want to miss. #RAPSConvergence is headed to Long Beach this September. Join us to learn from experts, get inspired, and further your regulatory career: https://bit.ly/3KZV4Is
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The European Commission has published results from a pilot study to understand the challenges to ensuring safe drug supply chains. While the commission said that one of the major challenges was getting information about critical medical products, it also noted the study has many shortcomings, making it hard to interpret the data. Ferdous Al-Faruque reports for Regulatory Focus: https://bit.ly/4bHMWaz
European Commission drug shortage pilot study highlights industry, regulatory challenges
raps.org
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The laboratory-developed test (LDT) industry and infectious disease clinicians called on the FDA to broaden guidance on enforcement discretion during a declared public health emergency and in immediate response to an emerging health threat to encourage the development of more diagnostic testing options. Mary Ellen Schneider reports for Regulatory Focus: https://bit.ly/4cMLlB8
Lab industry seeks more flexibility in FDA emergency enforcement guidance
raps.org