The print version of Fundamentals of Pharmaceutical and Biologics Regulations: A Global Perspective is out of stock. Stay tuned for a brand new edition arriving April 2026. You can still purchase an e ...

A new RAPS digital experience is coming! Parts of our website will be inaccessible between Saturday, 28 March and Wednesday, 1 April during the migration. These services include: the RAPS Marketplace, ...

Postapproval Changes for Drugs was developed for regulatory professionals of all levels of RAPS Regulatory Competency Framework, including newcomers and seasoned professionals as well as academics and ...

Comprised of 25 chapters from 30 experts from seven different countries, this edition incorporates a global overview of regulatory intelligence.

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.

Show the world that you have the foundational knowledge regulatory affairs professionals need. The new Foundation in Regulatory Affairs (FRA) assessment-based certificate is designed to help you build ...

Finding your way through the regulations, state-of-the-art standards, and interpretations applicable to health software, and, in particular, software as a medical device (SaMD), can be challenging.

Quality Management Systems for Drugs and Devices presents a comprehensive overview of quality management systems (QMS), with a focus on quality assurance, good manufacturing practice, good clinical ...

A new RAPS digital experience is coming! Parts of our website will be inaccessible between Saturday, 28 March and Wednesday, 1 April during the migration. These services include: the RAPS Marketplace, ...

Regulation of Regenerative Medicines: A Global Perspective takes a look inside the rapidly evolving cell therapy, gene therapy, and tissue engineering landscape in the US and other key world markets.

BALTIMORE @ While it@s important for regulatory professionals to translate regulatory intelligence to company leadership, it@s also important to focus on providing essential information for their ...

RAPS Regulatory Intelligence Conference is designed to explore key topics more in-depth, creating a collaborative environment for engaging education and professional development.