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 ...

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 ...

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 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 ...

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 ...

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 ...

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 Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US RFK Jr. says U.S. will stop funding global vaccine alliance Gavi (The Washington Post) RFK Jr. Is ...

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 ...

Recon: Lilly to acquire Verve in potential $1.3B deal; RFK Jr. eyes crackdown on drug ads ...

Fostering a company culture that drives widespread adoption is also central to maximizing unified RIM value. For many organizations, this may represent a significant change from a traditional ...