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 ...

Lisa brings over 30 years of experien ce working with worldwide regulatory strategies, marketing submissions and applications, FDA submissions, quality system strategies, SOP development and review, ...

The practice of a brand manufacturer delaying the launch of an authorized generic medication has declined over recent years, and its effects on the market can be both positive and negative depending ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Senators Propose Ban on Drug Advertising to Consumers (The Wall Street Journal) Sarepta reports ...

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 ...

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 ...

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 ...

Gene therapies have the potential to revolutionize disease treatment by addressing underlying genetic disorders, offering a beacon of hope in healthcare. However, their complexity and the rapidly ...

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.

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, FDA ...

Former US Food and Drug Administration (FDA) official Peter Marks critiqued the lack of public review in the agency@s recent COVID-19 vaccination policy in a New England Journal of Medicine article ...