Ready to take the next step in your RAC journey? The deadline to apply for a spring RAC exam is 27 February: https://hubs.la/Q033B6P80 Want to validate your knowledge of European regulatory requirements? Apply for an RCC exam here: https://hubs.la/Q033zSMV0
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 182,887 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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The medtech lobby group AdvaMed has asked the Trump Administration to reverse its recent firing of probationary staff at FDA's Center for Devices and Radiological Health. AdvaMed CEO Scott Whitaker said the administration's broad strokes approach to cutting probationary staff is inconsistent with its stated goals. Ferdous Al-Faruque reports in Regulatory Focus: https://hubs.la/Q037Yxjt0
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The Trump Administration’s move to defend the FDA's rule regulating laboratory-developed tests has caught some experts off guard, including Philip Desjardins, a partner at Arnold & Porter, who told to Focus he expected the government to walk back the rule. Ferdous Al-Faruque reports in Regulatory Focus: https://hubs.la/Q037YxqX0
Trump administration’s defense of LDT rule catches legal expert by surprise
raps.org
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Regulatory Affairs Professionals Society (RAPS) reposted this
Hearing new perspectives. Making new connections. #RAPSEuroConvergence is where we gather for in-depth discussions with industry and health authorities, all for the advancement of healthcare regulation in Europe and beyond. Get your ticket today to save before rates increase: https://hubs.la/Q037NRK90
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Know someone who goes above and beyond in building networks and supporting regulatory professionals in your community? They might be a good fit for our Community Leadership Award. Know an early-career professional making a significant difference in regulatory affairs? Nominating them for our Rising Star Award is a fantastic opportunity to honor their hard work and passion. All applications and nominations are due by 25 April 2025. Nominate a deserving colleague today: https://hubs.la/Q036pr8S0
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At this interactive workshop on 27 March, you will learn strategies to craft effective and concise messages that help you get regulatory work done. Learn to write better and influence business outcomes— no matter your writing ability and experience. Join expert speakers Nancy Singer and Robin Crawford as they share how to: ⭐ Create documents that will answer the readers’ questions before they ask them ⭐ Organize most documents in less than 60 seconds ⭐ Recognize when to use the active and when to use the passive voice ⭐ Format documents so they can be read easily on cell phones ⭐ Use online tools to analyze the readability of documents and format documents for eliminating extra spacing ⭐ Use a proofreading tool that will read documents aloud, and more This workshop is part of the RAPS Certificate in Effective Communication. Don't miss this workshop. Register today: https://hubs.la/Q037btG10
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The Trump Administration’s return-to-office mandate for federal employees, which also limits the hiring of remote workers, will restrict FDA's talent pool and weaken the agency, according to Wilson Bryan, who served as the director of FDA’s Office of Tissues and Advanced Therapies from 2016 until his retirement from the agency in 2023. Joanne Eglovitch reports in Regulatory Focus: https://hubs.la/Q037L1Kr0
Wilson Bryan: Return-to-office mandate will weaken FDA, impact hiring
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Recent mass layoffs at FDA will hinder the agency's reviews of new devices and result in the agency failing to meet the user fee goals outlined in the Medical Device User Fee Act (MDUFA), according to legal experts who spoke to Regulatory Focus: https://hubs.ly/Q037x5xS0
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FHIR (Fast Healthcare Interoperability Resources) is revolutionizing data exchange across the healthcare ecosystem. It enables smoother data sharing across platforms. Why it Matters: • Automation & efficiency: reduces manual processes and speeds up workflows. • Scalability: ensures easy data exchange across systems and devices. • Patient empowerment: offer patients direct access to their health records, in apps like Apple Health (using SMART on FHIR). • Regulatory integration: key to future FDA and EMA regulatory frameworks for electronic product labeling. FHIR represents the next leap in healthcare interoperability, building on earlier standards like SPL and enabling a more patient-centric approach. To explore how FHIR is evolving and what it means for product labeling, read the RAPS webinar highlights: https://hubs.la/Q032Tlzr0 Sponsored content from Schlafender Hase.
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FDA has cited several companies for failing to meet its current good manufacturing practices requirements. One company was also cited for refusing to allow inspectors into its facility and another was found to be falsifying documents. Ferdous Al-Faruque reports in Regulatory Focus: https://hubs.la/Q037wBQ70
Warning letters issued for cGMP violations, refusing entry, and falsifying documents
raps.org