We're looking for regulatory professionals with experience with medical devices and biopharmaceuticals to join the RAPS Education Committee! The RAPS Education Committee evaluates proposal submissions for RAPS education programs and makes sure our offerings are are suited to the needs of our members and the profession. Learn more here: https://bit.ly/4di6lQo
Regulatory Affairs Professionals Society (RAPS)
Non-profit Organizations
Rockville, MD 172,795 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
5635 Fishers Lane
Suite 400
Rockville, MD 20852, US
Employees at Regulatory Affairs Professionals Society (RAPS)
Updates
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We're looking for volunteers to help us with the RAC and RCC programs. The Regulatory Affairs Certification (RAC) and Regulatory Compliance Certification (RCC) are RAPS' industry-leading credentials for regulatory professionals. See how you can get involved: https://bit.ly/3Hp61SN
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The FDA has warned Brassica Pharma for numerous good manufacturing practice violations, including multiple instances of employees falsifying sterility and environmental monitoring data and lax controls to prevent microbiological contamination. https://bit.ly/3A2nj7e
FDA finds data integrity, sterility problems at Indian drugmaker
raps.org
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The FDA has finalized its guidance on evaluating real-world data from electronic health records. The agency's final guidance offers additional clarification on selecting study variables and validation. It alsoincludes recommendations for the use of quantitative approaches to aid in interpreting study results and analyzing potential misclassifications. Ferdous Al-Faruque explains in Regulatory Focus: https://bit.ly/4bW7dsN
FDA finalizes guidance on RWD from electronic health records
raps.org
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Here's what your peers are learning so far in 2024 💡 Browse our catalog of more than 50 courses on regulatory essentials, medical devices, pharmaceuticals, quality, and clinical to find one that fits your goals: https://bit.ly/3y6xIOz
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Show up to #RAPSConvergence in style! Browse our collection of polo shirts, tailored shirts, t-shirts, sweatshirts, tote bags and more: https://bit.ly/3wKoqae
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We're honored to celebrate the achievements of these talented regulatory professionals 👏 Each year, RAPS recognizes deserving individuals for their contributions to the regulatory profession through the RAPS Awards Program. Learn more about this year's recipients here: https://bit.ly/3Wm5fNP
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🔍 NAMSA Blog! 🔍 Understanding the Benefit-Risk Ratio in Clinical Reports: Avoiding 6 Common Mistakes Sponsored content from NAMSA: Navigating the complexities of the EU MDR 2017/745 can be challenging, especially when it comes to benefit-risk determination. Our latest blog dives deep into the importance of this critical analysis and highlights six common mistakes to avoid. 💡 Key Takeaways: 1. Thoroughly consider the state-of-the-art to avoid skewed assessments. 2. Position your device within the medical landscape effectively. 3. Utilize both qualitative and quantitative parameters. 4. Summarize the clinical benefits clearly. 5. Discuss and assess associated risks comprehensively. 6. Conclude with a well-rounded benefit-risk ratio. At NAMSA, our experts provide invaluable insights and recommendations to ensure your Clinical Evaluation Reports (CERs) meet MDR requirements. Don't miss out on these essential tips to enhance your compliance strategy! 👉 Read the full blog here: https://bit.ly/4esCiXO #MedicalDevices #ClinicalReports #MDRCompliance #BenefitRiskAnalysis #NAMSAKnows #RegulatoryAffairs
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We're delighted to confirm our Board of Directors for 2025! To our current and incoming board members, thank you for your commitment to the regulatory profession. Learn more: https://bit.ly/3ya8Wgs
RAPS announces Board of Directors slate for 2025
raps.org