CRED CMC 2017 - Day 2 slides

Chemistry, Manufacturing & Controls: The Evolving Pharmaceutical Dossier 18-19 October 2017, DoubleTree by Hilton London, Victoria

Day 1 Programme: Drug Substance Chair: Vimal Patel, GlaxoSmithKline

Time 09:00 09:30



Registration and Coffee

Vimal Patel GlaxoSmithKline Christopher Carr ERA Consulting

Welcome •

Overview of the day

Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘S’ • Origin of the Common Technical Document • Overview of CTD structure - where drug substance data fits (Module 3.2.S) • Different routes to incorporate drug substance data into 3.2.S: originator data, DMF or CEP • Overview of variations in the EU • Due Diligence Tips • The elements of a specification o New drug substances o Multi-sourced substances (EP and other pharmacopoeial monographs) • Analytical Methods Data Requirements and Practical Guidance for Drug Substance Development • Issues for different phases of development • Specifications and analytical methods • Production (scale-up, validation, starting materials, application of principles of GMP) • Stability programmes and data requirements • ICH Q11 and QBD Regulatory Agency’s Perspective on the Drug Substance Section of Marketing Authorisation Applications (MAAs) • Potential pitfalls and practical issues experienced with the active drug substance section of an MAA o The importance of validated analytical methods • Falsified Medicines Legislation Lunch Tea, coffee break Control of Drug Substances • Sources of drug substances



Alan Watt AstraZeneca, UK


Kate Arnot AstraZeneca, UK


12:00 12:45

Sue Harris MHRA

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