Spring Intro 2023

22/03/2023

CONCLUSION: The future is near, FUTURE is HERE Fast advancement of the pharmaceutics field, further catalyzed by COVID pandemic; significant number of initiatives reviewing the EU health legislative framework

Digital technology embedded in drug development e.g., decentralized clinical trials, AI

Next wave of gene and cell therapies gaining rapid ground

Enhanced Patient-Centric Drug Development

Increased transparency requirements

Enhanced innovation in quality and manufacturing

Increasing collaboration between global regulators

Modern regulatory evidence generation eg RWD

Closing the gap between HTA and regulatory bodies assessments

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Further reading

EMA Regulatory Science 2025 - 5 Goals European Commission: A Pharmaceutical Strategy for Europe European Health Data Space (EHDS) DARWIN (Data Analysis and Real-World Interrogation Network) EU Clinical Trial (CT) Regulation (No 536/2014) CT Directive (2001/20/EC) MDR (No 745/2017) Medical Devices Directive (MDD 93/42/EEC) Active Implantable Medical Devices Directive (AIMDD 90/385/EEC) IVDR (No 746/2017) Directive 98/79/EC ACCESS consortium ORBIS

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