About Euro Convergence RAPS Euro Convergence is the biggest regulatory affairs conference in Europe. It is where the regulatory affairs community comes together to share ideas, make connections, and ...

RAPS has named four regulatory professionals to the distinguished ranks of the RAPS Fellows Program. RAPS welcomes a new class of Fellows each year, honoring them for their noteworthy and sustained ...

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It’s hard to believe that RAPS Convergence 2024 is in the books. After years of preparation and hard work from regulatory professionals around the globe, the biggest regulatory event of the year blew ...

While a regulatory affairs career can take many paths, almost everyone who works in the field will tell you they had someone help them out early in their career. For Angelina Lisandrelli, it was a ...

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under ...

The main body of the new draft guidance runs to 17 pages and is accompanied by two appendices that give examples of component, part, material and software activities that might or might not be ...

In a new effort to boost alignment of scientific and regulatory approaches to generic drug development among global regulators, the US Food and Drug Administration is standing up a Generic Drug ...

The US Food and Drug Administration (FDA) is seeking comments on strategies for the pharmacological assessment of peptides, small polymers made up of 40 or fewer amino acids. “For the purpose of this ...

Patrizia Cavazzoni, MD, has been named director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER). The appointment, announced on Twitter Monday morning, ...

The European Commission earlier this month issued an updated notice detailing how it handles duplicate marketing authorization applications (MAAs) for pharmaceuticals and biologics, three years after ...

In recent years, global clinical trials have become standard, and for a good reason. In broad terms, expanding clinical trials across the world provides a better opportunity for demonstrating the true ...