Bettine Boltres, Ph.D.
Principal, Scientific Affairs, Packaging & Delivery Systems
European Medicines Agency's (EMA) Strategy on Engaging with Regulatory Science
Where science and technology are evolving quickly, a good networking structure is needed to keep pace of advancements. This is especially relevant for regulatory agencies in the pharmaceutical field. EMA recognizes this and addresses it with the strategic plan: Regulatory Science to 2025 – focused on quality, safety and efficacy of both human and veterinary medicines. The draft of this plan, which was created by the Member States and the European Commission, and comprised input from two workshops with stakeholders, was published in December 2018 for a six-month public consultation.
Regulatory Science to 2025 has five goals:
- Catalyzing the integration of science and technology in medicines development
- Driving collaborative evidence generation – improving the scientific quality of evaluations
- Advancing patient-centered access to medicines in partnership with healthcare systems
- Addressing emerging health threats and availability/therapeutic challenges
- Enabling and leveraging research and innovation in regulatory science
These goals contain core recommendations and actions that address specific topics such as precision medicine, biomarkers, advanced therapy medicinal products, novel manufacturing, and nanotechnology, and also futuristic topics such as artificial intelligence, 3D printing and big data.
West is vigilant of the ever-changing regulatory landscape in order to support customers with the information, products, and services needed in order to comply. For more information, contact and Account Manager or Technical Customer Support (TCS) representative, or visit the West Knowledge Center.