The European Commission has determined that there are no viable alternatives to titanium dioxide as an excipient in many pharmaceutical products. They also identified a risk of shortages if a ban were implemented, which could negatively impact patients due to the large number of medicinal products affected. Joanne Eglovitch reports in Regulatory Focus: https://hubs.la/Q03BWqK40
RAPS Europe
Professional Training and Coaching
Sint-Pieters-Woluwe, Brussels Region 12,413 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 chapters and affiliates worldwide.
- Website
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https://www.raps.org/
External link for RAPS Europe
- Industry
- Professional Training and Coaching
- Company size
- 11-50 employees
- Headquarters
- Sint-Pieters-Woluwe, Brussels Region
- Founded
- 1976
- Specialties
- regulatory, regulatory affairs, medical devices, medical technology, pharmaceuticals, medicine, and biotech
Updates
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📝Regulatory due diligence, explained. This expert-backed course can help you prepare for due diligence, so you can make sure your company is ready for any surprises. Learn more about this course: https://hubs.ly/Q03BvYr70
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Our community works all year to make sure #RAPSConvergence serves the entire regulatory affairs community: across sectors, across the globe, and for everyone whose job requires regulatory affairs knowledge. This year’s event in Pittsburgh, PA, is full of expert-led sessions designed to give you access to one-of-a-kind, interactive lessons you cannot get anywhere else. Join us for three days of incredible learning and networking, and leave inspired to perform the important regulatory work that delivers safe and effective healthcare products to the patients who need them. Get your ticket today to save: https://hubs.la/Q03BrqF40
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Postmarket clinical follow-up (PMCF) surveys are a proven method for collecting the data used for EU MDR submissions, but there is limited guidance on survey procedure and use. In this peer-reviewed article, Marcus Torr, Tonika Chester, MSc, Alice Robertson, BSc, and Isabel Bradshaw, MSc explore the challenges in planning and executing high-quality Level 4 and general/usability Level 8 PMCF surveys, as outlined in Appendix III of the Medical Device Coordination Group (MDCG) 2020-6 guidance document. RAPS members get exclusive access here: https://hubs.la/Q03zh4mH0
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The best way to learn these leadership attributes: by practicing with your peers! That’s why we are holding a group training for regulatory affairs leaders this autumn. At our RAPS Advanced Strategic Communication Certificate Program, Nancy Singer, Richard DeRisio, and Rosanne Melikian will lead you through case studies that allow you to address real-life problems, and practice communication techniques you can apply immediately at your job. Secure your space in the program today: https://hubs.la/Q03zKzSf0
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So many chances to learn from experts in regulatory affairs. Get your ticket to one of our interactive live workshops: https://hubs.la/Q03B2WRQ0 And do not miss your chance to save on #RAPSConvergence! Get your ticket for the biggest event in regulatory affairs by 12 August to take advantage of Advance Registration rates: https://hubs.la/Q03B2Wvy0
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𝗦𝘁𝘂𝗱𝗲𝗻𝘁 𝗔𝗺𝗯𝗮𝘀𝘀𝗮𝗱𝗼𝗿 - 𝗥𝗔𝗣𝗦 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 𝗦𝗲𝗿𝗶𝗲𝘀 Are you a university 🎓 student based in Europe? Are you interested in a career opportunity in regulatory affairs? We are looking 👀 for you! Regulatory Affairs Professionals Society (RAPS) seeks student volunteers to serve as ambassadors at our upcoming European Conference series in Rotterdam, NL. If you are looking for opportunities to grow your professional development and network with like-minded regulatory professionals, please apply. Create your RAPS profile and apply today! Link to application portal: https://lnkd.in/eB7sMbVz IPSF - International Pharmaceutical Students' Federation EPSA - European Pharmaceutical Students' Association Biomedical Alliance in Europe #regulatoryaffairs #networking
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RAPS Europe reposted this
The US Food and Drug Administration (FDA) has published its user fee rates for fiscal year 2026 across its prescription drug, generic drug, biosimilar, and medical device programs. The rates are calculated by factoring in the agency’s resources against the number of applications it expects to receive over the next fiscal cycle based on historical trends.
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Registration is now open for our popular online regulatory affairs leadership program with eCornell! Designed by Cornell faculty and experts, this certificate program is designed to help you learn the in-demand business and leadership skills that lead to better outcomes for companies and more effective (and respected) regulatory teams. Over six online courses and one live capstone class, you will navigate challenging and rewarding topics that will prepare you to make tough decisions, lead with credibility, act ethically, and much more. Plus, this flexible program fits into your busy schedule while still helping you build bonds with your peers in regulatory affairs. This program sells out every year, so book your spot today: https://hubs.la/Q03zqV1T0
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The regulation of medical devices is critical to ensuring patient safety and broad access to innovative, state-of-the-art medical technology. However, the US and EU approaches to regulation differ. In this peer-reviewed article, Matthias Fink, MD, Amelia Hufford, PhD, Scott Snyder, PhD, Breda Kearney, MSc, and Susan Partridge, PhD highlight the similarities and differences in the acceptance of real-world evidence as clinical data for medical devices in the US and the EU: https://hubs.la/Q03zh5yt0