Become a speaker or poster presenter in Lisbon The Euro Convergence Programme Committee invites you to propose a preconference workshop, concurrent session, solutions circle, or poster presentation ...

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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We spoke with five RAPS Convergence attendees to get their reactions on what made this event special, from a focus on artificial intelligence (AI) to finding community, and more.

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 ...

At what point does manipulation or repair of a medical device cross the line from @servicing@ to @remanufacturing?@ A new draft guidance from the US Food and Drug Administration (FDA) provides a set ...

A primary goal of the Generic Drug Cluster will be to help international regulators reach a common understanding of requirements for generic approvals, and to share their current thinking on related ...

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. @ ...

The appointment, announced on Twitter Monday morning, comes after Cavazzoni spent the past year as acting director of CDER. A game of musical chairs within FDA has been created by securing the ...

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 ...