We're honored to present the 2024 RAPS Fellows! These regulatory professionals join the venerated ranks of the RAPS Fellows. Fellows serve as important advisors and mentors for strategic collaboration, implementation of special initiatives, and international development across the regulatory community. Learn more here: https://bit.ly/4bIDOSP
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 172,341 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
-
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
-
Primary
5635 Fishers Lane
Suite 400
Rockville, MD 20852, US
Employees at Regulatory Affairs Professionals Society (RAPS)
Updates
-
China is the world‘s second-largest pharmaceutical market, attracting numerous international pharmaceutical companies seeking marketing authorization for their active pharmaceutical ingredients and finished products. In this article from the latest issue of RF Quarterly, Lixue Zhang, MS, RAC, explores the quality considerations for international generic pharmaceutical products launched in the Chinese market. She also covers the fundamental principles of developing regulatory specifications, focusing on the stringent standards set by the Chinese Pharmacopoeia for residual solvents, heavy metals, and ignition residue. RAPS members get exclusive access to this article: https://bit.ly/4c1WkGv
-
The FDA has issued a draft guidance to spur the development of new treatments for pediatric ulcerative colitis and pediatric Crohn’s disease, two types of inflammatory bowel disease. The guidance addresses study population, study design, efficacy considerations, and safety assessments. The guidance does not address extraintestinal manifestations, stricturing or fistulizing disease, or treatment of long-term complications of pediatric UC or CD. Joanne Eglovitch reports for Regulatory Focus: https://bit.ly/3xQvumo
-
We're hiring for three roles to bolster our books and journals teams to meet the professional development needs of those in the healthcare regulatory field! Know someone who might be interested? Here's where to send them 👉 https://bit.ly/4cSHxhy
-
FDA on Tuesday finalized guidance for sponsors explaining how it assesses user fees for combination products and the different programs available to sponsors for requesting user fee waivers under the Prescription Drug User Fee Act and the Medical Device User Fee Amendments programs. Joanne Eglovitch reports in Regulatory Focus ✍️ 📣 https://bit.ly/3LxhfFW
FDA issues final guidance user fees for combination products
raps.org
-
FDA's Center for Devices and Radiological Health on Monday announced it has elevated its communication office to a new “super office” as part of a move to increase its organizational agility and enable the center to meet its Medical Device User Fee Amendments V goals as well as its strategic priorities for 2022-2025. Joanne Eglovitch reports in Regulatory Focus 📣 https://bit.ly/3Wt5KWF
CDRH announces reorganization, new communication ‘super office'
raps.org
-
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
EU publishes regulation governing use of AI in medical devices and IVDs
raps.org
-
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
-
-
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
-
-
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
-