Today's your day to save on regulatory career resources! Save 30% on select RAPS books, Online University certificates and individual courses, and RAC Prep bundles today only! This is our biggest sale of the year 😎 Shop today: https://bit.ly/4cefY2l
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 173,954 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
-
The European Commission has proposed updating common specifications for certain class D in vitro diagnostic devices to consider tests for certain parasites and viruses that are of public health concern. Stakeholders have four weeks to comment on the proposed amendments. Ferdous Al-Faruque has the details in Regulatory Focus: https://bit.ly/4fXUysL
-
Did you know: our research on the regulatory profession with elemed lets you explore data on the regulatory profession in your area, or any area your company wants to learn more about. See how this free report provides a snapshot of the size and health of the regulatory affairs profession: https://bit.ly/4d2i1Yl
-
-
The International Council for Harmonisation on Wednesday announced that its ICH E11A guideline, which establishes a harmonized framework for extrapolating drug development data from adult trials to pediatric populations, has reached Step 4 of the ICH process and is ready for regulators to implement in their local jurisdictions. Joanne Eglovitch reports in Regulatory Focus 📣 https://bit.ly/3Mhdx3U
ICH adopts E11A guideline to spur pediatric drug development
raps.org
-
Where collaboration reigns. At Solutions Circles, #RAPSConvergence attendees talk through regulatory scenarios and apply critical thinking in real time. They're one of our attendee favorites for a reason. 😎 Get your ticket for RAPS Convergence today: https://bit.ly/4fTEvMt P.S.: Registration rates go up on 28 August, so don't wait to get your ticket!
-
We're so glad to see the excitement around our new Collaborative Communities initiative. 💫 These new RAPS member-exclusive groups are here to let you explore the regulatory topics that interest you in an environment with others who share your curiosities. If you're a RAPS member, you can join a group here: https://bit.ly/3Xhy7Yp
-
For regulatory professionals, good communication skills go so much further than just sending emails to coworkers. Regulatory professionals need to: 💡Write concise, clear messages 💡Hold effective meetings 💡Mediate disputes 💡Create documents that do not get them or their organizations into trouble 💡Make the most of their time with company executives So that's what Nancy Singer and Robin Crawford-Kirschner, CMP, DES are teaching in our RAPS Certificate in Effective Communication. Each one of the five courses in this certificate program will focus on a topic mentioned above in an engaging environment that encourages sharing and discussion. These courses are designed for regulatory professionals of all backgrounds and levels of experience, from regulatory newcomers all the way up to the C-suite. Sign up today to get learning: https://bit.ly/3X3sddd
-
Making real connections in our field is so important. 🤝 We can't wait to re-connect with our regulatory community at #RAPSConvergence2024. Get your ticket here by 27 August to save on registration: https://bit.ly/4ckRhAx
-
FDA has issued a draft guidance detailing what modifications the agency considers appropriate for pre-determined change control plans, and what information sponsors should include in their premarket approval, de novo, or 510(k) submissions to support the acceptance of their proposed PCCP. Ferdous Al-Faruque reports in Regulatory Focus 📝 📣 https://bit.ly/3yGtFc7
FDA issues much-anticipated PCCP draft guidance
raps.org
-
Limited use of unique device identifiers in electronic health records and funding shortfalls are key challenges affecting FDA's active postmarket surveillance program for medical devices, according to a recent report by the Government Accountability Office. Joanne Eglovitch reports in Regulatory Focus 📢 https://bit.ly/4dM1Yxu
GAO: UDI, funding shortfalls weaken FDA's active surveillance program for devices