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Join experts as they demystify EUDAMED’s UDI requirements and offer actionable insights to help MedTech enterprises craft a comprehensive UDI strategy to drive compliance to EUDAMED and future UDI ...

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 ...

This event will share an update to the AI landscape, including challenges to AI development, standards & regulations to address these challenges, and a deeper dive into AI risk and AI cybersecurity.

In this half-day workshop, we will discuss the evolving regulatory landscape shaping global health product labeling and compliance.

The International Council for Harmonisation (ICH) has released its highly anticipated draft guideline that harmonizes principles for the design, analysis, and reporting of adaptive clinical trials in ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, we ...

The US Food and Drug Administration (FDA) has released draft guidance outlining when combination products with device constituent parts are subject to unique device identifier (UDI) requirements. @ ...

Head of Education Programs Location: Rockville, MD (Hybrid or Remote) Key Skills: Program planning, budgeting, managing, and implementing Experience: 4-6 years of experience Reports to: Senior VP of ...

This presentation aims to build a foundational level of regulatory science around development of biosimilar drug products. We will also discuss challenges to biosimilar development and regulatory ...

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid the groundwork for the implementation of new clinical trial regulations in April 2026 by publishing a series of guidelines.