Regulatory Affairs Professionals Society | RAPS
WEBRegulatory Affairs Professionals Society | RAPS. 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.
Join RAPS
WEBRAPS 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.
RAC | RAPS
WEBThe Regulatory Affairs Certification (RAC) is the leading credential for regulatory professionals in the healthcare sector. There are two RAC designations. There is one for Pharmaceuticals (RAC-Drugs) and one for Medical Devices (RAC-Devices). Candidates may take one exam or both exams.
Regulatory Affairs Certificate: Pharmaceuticals - RAPS
WEBMember: $2545.00 Nonmember: $3190.00. Add to Cart. The Regulatory Affairs Certificate: Pharmaceuticals provides a cost-effective, convenient option that will equip you or your organizational team with the tools and knowledge needed to progress as a regulatory professional and stay ahead of the competition. Whether you are new to the regulatory ...
Regulatory Focus™ | RAPS
WEBDiscover more of what matters to you. 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.
FDA issues new unit-dose repackaging guidance - RAPS
WEBThe agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products ...
Member Dashboard - RAPS
WEBMember Dashboard | RAPS. 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.
FDA updates guidance on expanded access for investigational
WEBNov 2, 2022 · The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now includes new frequently asked questions about how expanded access should be implemented given new regulatory access and statutory requirements through the 21st Century Cures Act (Cures Act) and FDA ...
FDA drafts safety reporting guidance for drug and device ... - RAPS
WEBOct 1, 2021 · The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices. The draft, published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on ...
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WEBWe're happy to welcome you as a guest and can help you become a member later if you change your mind. Create an Account. Regulatory Affairs Professionals Society (RAPS) 5635 Fishers Lane, Suite 400. Rockville, Maryland 20852. P +1 301 770 2920 F +1 301 841 7956. Email: [email protected].