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 ...

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).

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 RAPS Marketplace will be under maintenance on 26 June 10 PM to 11 PM ET. RAPS Marketplace may be unavailable during this window. We apologize for any inconvenience caused during this time.

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 presentation will focus on the promise if gene therapies for treating genetic diseases and the complex regulatory challenges they face due to evolving science and varied global standards.