• RF Quarterly

    The ICH over the last 30 years: A personal reflection

    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...
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    500+ gather in Amsterdam for Euro Convergence, RAPS’ largest-ever European event

    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...
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    Euro Convergence: AI, notified body shortage top health authorities session

    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...
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    RAPS Euro Convergence features speakers from EMA, FDA, and Swiss, Austrian and UK health authorities, as well as notified bodies

    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...
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    RF Quarterly, December 2021: Key takeaways from RAPS Convergence 2021

    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...
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    Feature ArticlesFeature Articles

    ICH implementation: The transition from convergence to harmonization

    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 ...
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    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    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...
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    RAPS Convergence 2021 brings regulatory community together virtually to hear from regulators, learn from each other and celebrate the profession

    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...
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    Convergence: Inadequate testing of cell and gene therapies draws FDA concern

    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 ...
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    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...