RAPS Convergence is a cornerstone of education and networking for regulatory affairs professionals. After two years of virtual conferences, the premier regulatory affairs gathering is once again a live event.  Regulatory professionals are taking over Phoenix, AZ. from Sept. 11-13 for RAPS Convergence 2022 . We’ll descend on the Phoenix Convention Center for three days of connection, education and inspiration. It’s time to reunite. The Convergence 2022 Planning Committe...

The Regulatory Affairs Professionals Society (RAPS) is pleased to announce that US Food and Drug Administration (FDA) Commissioner Robert Califf, MD will speak at RAPS Convergence 2022, 11-13 September, in Phoenix, AZ at the Phoenix Convention Center.   After holding two years of virtual conferences, Convergence will commence its return to an in-person meeting with an opening plenary session where Califf will present on 11 September at 4:30 pm MDT. The commissioner w...

Euro Convergence, RAPS’ annual gathering of medical device, in vitro diagnostic (IVD) and pharmaceutical regulatory professionals, returned in person to Amsterdam on 11-13 May 2022 . More than 500 participants, including 120 industry expert speakers from more than 30 health authorities and notified bodies, made it an event to remember in Amsterdam after two years of virtual conferences. Delegates submitted a record-breaking 20 posters for Euro Convergence 2022. Raque...

This article gives a personal reflection on the development of ICH since its inception in 1990 and during which time the author was involved both as a regulator and, more recently, an industry participant. The evolution of ICH is discussed as it has moved from an international organization involving three regions to a truly global body. The successes and the challenges are discussed, and consideration is given to future development.   Keywords – international harmo...

RAPS today wrapped up the final day of Euro Convergence 2022, which took place live and in-person in Amsterdam after being held virtually the previous two years. Euro Convergence is the premier annual event for European regulatory professionals. This year’s event drew more than 500 participants from six continents and 33 countries. Attendees gathered for three days of education sessions, expert presentations and panel discussions curated exclusively by European regulato...

AMSTERDAM – European healthcare product regulators should begin to focus on harmonizing guidance on artificial intelligence/machine learning (AI/ML) across regulatory regimes, according to a panel of health authority representatives at a townhall meeting at the 2022 RAPS Euro Convergence.   On 11 May, a high-level group of representatives from health authorities, notified bodies, and regulatory agencies opened themselves up for questions from delegates who asked them a...

Prominent officials from the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), Swiss, Austrian and UK national health authorities, and several notified bodies will speak at the upcoming RAPS Euro Convergence . The annual three-day conference devoted to European healthcare product regulations and regulatory issues will take place, 10–12 May in Amsterdam. More than 120 expert speakers will provide updates and insights on important European regul...

Welcome to the December issue of RF Quarterly which focuses on key takeaways from RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.   Patient perspective and global harmonization There is increasing recognition of the importance of patients...

This article examines the transition from convergence to harmonization for global pharmaceutical regulatory requirements. It outlines the roles of International Council for Harmonisation (ICH) and World Health Organization (WHO) in the implementation of ICH guidances and provides definitions for convergence and harmonization to reflect their distinctive roles. The authors also address ongoing harmonization initiatives, the current degree to which implementation has or has ...

Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...

RAPS today wrapped up its annual RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. The event drew more than 1,500 participants again this year—from 37 countries around the globe—in the second year it was held virtually. Convergence 2021 attendees heard from more than 300 expert speakers, including more than 50 from national and regional health authorities and notified bodies from around the world. More t...

The lack of consistent testing in measuring product quality for cell and gene therapies is a major deficiency found by US Food and Drug Administration (FDA) reviewers in its information requests (IRs) to manufacturers in their submission of biologics license applications (BLAs).   This observation was made by Kedest Tadesse, senior research manager for Agency IQ, which recently compiled a survey of deficiencies identified in IR letters in FDA’s review of five approved ...