Regulatory Affairs Professionals Society
The Regulatory Affairs Professionals Society (RAPS) is the largest global community dedicated to individuals involved in the regulation of healthcare and related products, such as medical devices, pharmaceuticals, biologics, and nutritional items. Established in 1976, RAPS played a significant role in shaping the regulatory profession and continues to provide support as a neutral, non-lobbying nonprofit organization. RAPS offers a variety of resources, including education and training, professional standards, publications, research, knowledge sharing, networking opportunities, and career development. It also provides the Regulatory Affairs Certification (RAC), which is the only post-academic professional credential that acknowledges excellence in the regulatory field. RAPS is based in the suburbs of Washington, DC, and has chapters and affiliates around the globe.
Outlet metrics
Global
#206696
United States
#75952
Health/Biotechnology and Pharmaceuticals
#55
Articles
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1 month ago |
raps.org
The European Commission is asking for stakeholder input on a plan to allow electronic medical device instructions for use (eIFU) 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. @
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1 month ago |
raps.org
The staffing cuts at the US Food and Drug Administration (FDA) have created a climate of uncertainty surrounding clinical trials. As a result, many companies are considering the possibility of developing drugs in other countries. This situation is perceived by some as a @gift to China,@ which has been intensifying its efforts in the pharmaceutical space, according to Jeremy Levin, CEO of Ovid Therapeutics. @
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Jan 20, 2025 |
raps.org
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance to help medtech manufacturers comply with its updated postmarket surveillance (PMS) regulation, which goes into effect this summer. The guidance was published alongside other guidances that sponsors should refer to ensure their specific product complies with the upcoming regulation.
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Jan 16, 2025 |
raps.org
Legislation passed late last year introduces clearer, more stringent PMS requirements proportionate to each device@s risks. The new law improves regulatory oversight, increases the scope of devices subject to PMS requirements, and requires manufacturers to have a postmarket surveillance plan and system. It comes into force on 16 June. @
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Jan 7, 2025 |
raps.org
The US Food and Drug Administration (FDA) has finalized a guidance to assist sponsors interested in participating in the Advanced Manufacturing Technology (AMT) designation program. @
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