Oh, the unexpected journey that is a career in regulatory affairs ??. We asked RAPS members to share the path that led them to a career in regulatory. Your answers did not disappoint. Join the discussion in Regulatory Exchange, our RAPS members-only community: https://hubs.la/Q038H8x50
Regulatory Affairs Professionals Society (RAPS)
非盈利组织
Rockville，MD 183,272 位关注者
Driving Regulatory Excellence
关于我们
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.
- 网站
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https://www.raps.org
Regulatory Affairs Professionals Society (RAPS)的外部链接
- 所属行业
- 非盈利组织
- 规模
- 51-200 人
- 总部
- Rockville，MD
- 类型
- 非营利机构
- 创立
- 1976
- 领域
- regulatory profession、regulatory affairs、professional association、medical devices、pharmaceuticals和biotechnology
地点
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主要
获取路线
5635 Fishers Lane
Suite 400
US，MD，Rockville，20852
Regulatory Affairs Professionals Society (RAPS)员工
动态
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FDA is exploring a new regulatory framework for human cells, tissues, and cellular and tissue products in response to the growing variety and complexity of these products, which can no longer easily be categorized into broad classifications. Joanne Eglovitch reports in Regulatory Focus: https://hubs.la/Q038zqHc0
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SGS is attending the RAPS Global Regulatory Strategy Conference on March 11-12. As a world leader in assessment, auditing and certification, SGS offers comprehensive support for regulatory compliance. SGS medical device services include EU MDR, UKCA, ISO 13485, MDSAP, Software as a Medical Device certification, orthopedic and dental MDR/UKCA, supply chain services and training. Visit SGS at Table 10 to discuss your regulatory compliance needs! Learn more: https://hubs.ly/Q038mNrv0 Sponsored content from SGS.
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The European Medicines Agency has published work plans for its Infectious Disease Working Party and Oncology Working Party, outlining the actions these groups will undertake over the next three years. Joanne Eglovitch reports in Regulatory Focus: https://hubs.la/Q038nkCL0
EMA publishes work plans for infectious diseases and oncology
raps.org
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Stakeholders want more clarity, detail, and flexibility in a recent guidance proposed by FDA for sponsors developing cell and gene therapies. Some specific areas the commenters addressed include alignment with past policies, the use of surrogate endpoints, and expanding and updating the guidance as FDA gains more experience in this field. Ferdous Al-Faruque reports in Regulatory Focus: https://hubs.la/Q038m-ZG0
Stakeholders seek clarification, flexibility, expansion of CGT guidance
raps.org
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We are thrilled to announce that PTC is a Gold Sponsor at the RAPS 2025 Regulatory Intelligence Conference on March 13-14th! Join PTC at their Solutions Circle and tabletop exhibit to discover how their solutions reduce costs, improve re-use, create auditable records, and minimize regulatory overhead. See how PTC's patented design control capabilities and regulatory submissions help medical device manufacturers achieve efficiency gains and better patient outcomes. Don't miss this opportunity to see how PTC is propelling medical device manufacturers forward. Learn more: https://hubs.la/Q0380Ss60 Sponsored content from PTC.
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Explore courses that focus on the key challenges of global regulations in both pharma and medical devices. Whether it’s clinical research trials or the regulations of IVDs outside of the US, we know the importance of building your knowledge in international regulations in 2025 and beyond. Learn more about courses that focus on international regulations: https://hubs.la/Q0380fW70
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The European Commission is asking for stakeholder input on a plan to allow electronic medical device instructions for use be provided to healthcare providers for all devices, not just high-risk products. The consultation was released on 21 February and stakeholders have a month to provide feedback. Joanne Eglovitch reports in Regulatory Focus: https://hubs.la/Q0389W0X0
European Commission launches consultation on electronic instructions for use
raps.org
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A week after firing hundreds of its probationary workers, FDA has pulled an about-face and is asking some of those it laid off to return to their jobs. FDA’s human resources department called and emailed an undisclosed number of recently laid-off staff and asked them to return to their jobs over the weekend. Despite the partial reversal, sources who spoke to Regulatory Focus said that the damage has already been done in terms of trust and morale. Ferdous Al-Faruque reports in Regulatory Focus: https://hubs.la/Q038cC3h0
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Dr.Evidence is the AI-enabled landscape intelligence platform for life sciences, transforming the way an organization works to drive regulatory submission and commercialization success. Accelerate the speed and quality of your strategic regulatory deliverables by tapping into the platform built on 20 years of domain expertise, the most contemporary, comprehensive set of landscape content available with drug labels from 9 major health authorities, regulatory approval packages, guidance documents, clinical trials, published literature and beyond, and AI that delivers both efficiency and accuracy. Learn more and request a demo: https://hubs.la/Q03802wt0 Sponsored content from Dr.Evidence.
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