Learn and network with your peers at the 2025 MEA MedTech Regulatory Summit, convening 30 January 2025 at the voco Dubai in Dubai UAE. The event programme was curated by experts across the medtech community to ensure you will have access to the highest quality discussions, knowledge exchanges, and collaborative opportunities. Reserve your seat today: https://hubs.la/Q03024kJ0
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 178,638 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
Get directions
5635 Fishers Lane
Suite 400
Rockville, MD 20852, US
Employees at Regulatory Affairs Professionals Society (RAPS)
Updates
-
Thanks to the contributions of our members, RAPS was able to offer all-new benefits in 2024. Thank you to all of the RAPS members who participated in our new RAPS Mentoring Program and Collaborative Communities this year! Learn more about these new RAPS member benefits and much more from 2024: https://hubs.la/Q030nTfv0
-
FDA issued an updated final guidance on Tuesday addressing the submission of unique device identifiers to the Global Medical Device Nomenclature Database. Joanne Eglovitch reports in Regulatory Focus 📝📢https://hubs.la/Q030kyKD0
-
The European Medicines Agency and the Heads of Medicines Agencies on Wednesday announced a revised guidance aimed at creating a consistent approach for identifying commercially confidential information and personal data in marketing authorization applications for human medicines. Joanne Eglovitch reports in Regulatory Focus 📢https://hubs.la/Q030b36d0
EMA, HMA overhaul guidance on data transparency in MAAs
raps.org
-
The FDA’s Electronic Submission Template and Resource, better known as eSTAR, recently marked its one-year anniversary as the mandatory template for medical device manufacturers submitting 510(k) applications to the FDA. In this article from the latest issue of RF Quarterly, PRITHUL BOM, Surina Gulati, and Melissa Hall provide guidance on how to create a 510(k) submission that will have the greatest chance of achieving a substantial equivalence determination. RAPS members get exclusive access to this article: https://hubs.la/Q02_vnD00
-
-
Namandjé Bumpus, FDA's principal deputy commissioner and second in command, will be leaving the agency at the end of the year, according to an internal email reviewed by Focus. Joanne Eglovitch reports in Regulatory Focus 📢https://hubs.la/Q0301dyn0
Deputy Commissioner Bumpus announces departure from FDA
raps.org
-
💙Thank you to all of the regulatory professionals who volunteered their time in ways big and small to make 2024 a year to remember. Join us in looking back on our year in regulatory, then tell about a highlight from your year: https://hubs.la/Q0304gkj0
-
The goal of any submission to a global health authority such as FDA or EMA is to provide information in a clear and organized format. Do your submissions efficiently facilitate review and enable regulators to better understand and approve your product? Speaker Arvilla Trag will share how to provide structure and content to Module 3 of the Common Technical Document (CTD) that will facilitate review and avoid frustrating reviewers. Save your seat today: https://hubs.la/Q02_PMcH0
-
-
The Pharmaceutical Inspection Co-operation Scheme recently released two documents aimed at creating a harmonized approach for planning, conducting, and following up on remote and hybrid inspections among its members. Joanne Eglovitch reports in Regulatory Focus ✔️https://hubs.la/Q03015f20
PIC/S offers guidance on remote inspections
raps.org
-
Both RAPS and DIA are counting the days until we all gather again in Brussels on 28-29 January. We’ll be building upon last year’s highly successful inaugural event. There is no better venue to connect with representatives from EMA, the European Commission, Notified Bodies, National Competent Authorities and Industry. Some of the topics we will cover: ✔️Article 117 of the MDR ✔️Rule 14 of the MDR ✔️Rule 21 of the MDR ✔️New EU General Pharmaceutical Legislation ✔️Updates and the latest EMA guidance ✔️Updates on COMBINE for Combination Products and Diagnostics and much more Meet us in Brussels! Save your seat today: https://hubs.la/Q02_PMcr0
-