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The call will explain the many benefits of participating in a RAPS chapter and will highlight opportunities for you to get involved as we seek new volunteers and a leadership team. As a Chapter leader ...
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 ...
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 ...
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.
Join us for a dynamic, credit-eligible workshop, co-sponsored by Network Partners Group and Loftware, focused on 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 agency recommended not placing a UDI on the label of a single-entity combination product and placing a UDI on a device-led co-packaged combination product, but not on each device constituent part ...
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 ...
Biosimilars – Development Complexities and Global Regulatory Strategies This presentation aims to build a foundational level of regulatory science around development of biosimilar drug products. We ...
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.