Year: 2025
Type: article
Abstract: regulators, biopharmaceutical companies, and other interested stakeholders to prepare and develop the Global Regulatory Affairs workforce of the future. Trends Shaping Drug DevelopmentWe are entering a pivotal era in drug development where scientific advances are helping bring new therapeutic modalities, personalized medicines, and novel drug-device combination products to patients more efficiently than ever before.Through digital integration we can generate novel types of evidence and enable more efficient regulatory submissions and reviews.Global regulators are also shifting towards increasing acceptance of innovative trial designs and embracing international collaboration.It is an exciting era for drug development with transformation that requires workforce adaptation.As leaders of biopharmaceutical regulatory affairs organizations, we must learn from the past, thrive in the present and strive for an even better future.We understand the strategic role regulatory affairs professionals play in biopharmaceutical companies, one that uniquely spans the entire continuum of drug development.Our professionals must navigate the increasingly complex regulatory environment, strengthening company engagement with global regulators and other stakeholders to successfully deliver innovative products to patients.Our organizations are only as strong as the people on our teams.As the future of therapeutic development changes in response to technological and scientific advances, we have an obligation to develop, recruit and retain top talent, and build a competency framework to not only meet today's demands, but to better equip the workforce of the future to improve patients' access to treatments.There is a great opportunity before us-upskilling our current professionals, attracting individuals with a diversity of expertise into the profession, and setting up the next generation for dynamic and successful careers.This is a call to action for professional societies, academic organizations, Eddie Reilly formerly affiliated with Sanofi.
Authors: Lina AlJuburi, Nicole Mahoney, Eddie Reilly, Amy Bertha, David C. Isom, Fabio Bisordi, Virginia Beakes-Read, Michael Garvin, Donna Boyce, Kevin Carl, Sean P. Curtis, Jennifer Dudinak, Carlos O. Garner, Nahid Latif, Sabine Luik, Michelle Rohrer, Katrin Rupalla, Mark Taisey, Raymond Votzmeyer, Max Wegner, Kathy Williams
Institutions: Sanofi (France), Novartis (United States), Bayer (Germany), Pfizer (United States), Roche (Switzerland), Johnson & Johnson (United States), AstraZeneca (United States), Merck & Co., Inc., Rahway, NJ, USA (United States), Bristol-Myers Squibb (United States), Eli Lilly (United States), GlaxoSmithKline (Germany), Amgen (United States), AbbVie (United States), AstraZeneca (United Kingdom)
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,090
OpenAlex ID: W4417091117