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Regulatory Panel Discussion: Practical Applications of Current Standards and Regulations in the Context of Digitalization
Date
December 11, 2023
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The Pharma 4.0™ and Annex 1 Regulatory Panel Discussion will bring together regulators from around the world to provide insights on the implementation of Pharma 4.0 concepts to different manufacturing technologies. Panelists will discuss the interpretation and practical application of current standards and regulations in the context of digitalization, and outline opportunities for future harmonization that can facilitate digital transformation including technologies such as the use of Artificial Intelligence.
Speakers
Head of Operations Quality Compliance and External Affairs, AstraZeneca
Yvonne Duckworth, PE
Fellow - Digital Technology, Associate, CRB
Joel Welch, PhD
(OBP), FDA
Head of Quality and Safety of Medicines, EMA
Head of Pharmaceutical Inspection & Enforcement,, Spanish Agency of Medicines and Healthcare Products
Global Head of Group Smart Manufacturing, Merck KGaA Darmstadt, Germany
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