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, ...

Singapore’s Health Sciences Authority (HSA) is running a consultation into plans to exempt more types of artificial intelligence (AI)-software as a medical device (SaMD) products from its license and ...

The European Commission is holding a consultation into joint clinical assessments of medical devices and in vitro diagnostics under the Health Technology Assessment Regulation (HTAR). Last year, the ...

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 ...