CRED: CMC – Drug Substance and Medicinal Product

The Evolving Pharmaceutical Dossier

14th October 2010: Drug Substance

Programme includes

Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘S’

• Legal framework
• An outline of the different sections within Module 3.2.S and an overview as to content within each section.
• What is a DMF?
• What is the Certificate of Suitability?
• How are these documents incorporated into the CTD Module 3, Part “S”?
• Other sources of information to support 3.2.S.
• ICH Q11 and QBD

Control of Drug Substances

• Sources of drug substances
• The elements of a specification
• New drug substances
• 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
• Variations

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
• An agency perspective on common findings arising during regulatory review
• Current experience and advice on preparation of the drug substance section of the CTD
• Quality Overall Summary –what reviewers want to see
• Inspection issues for drug substance manufacturers

Also available as a one-day course. Ref: CMC-1

15th October 2010: Medicinal Product

Programme includes

Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘P’

• Legal framework
• An outline of the different sections within Module 3.2.P and an overview as to content within each section.
• Key Sources of reference information concerning the CTD and data requirements for the medicinal product
• ICH Q8 and QBD

Control of Medicinal Product

• Who & what controls medicinal products?
• Overview of various types of medicinal products (new/established actives, different formulations) and aspects of their control.
• Construction, contents and justification of specifications for a range of dosage forms
• Analytical Methods and their validation
• Batch analysis and CofAs

Data Requirements and Practical Guidance for Medicinal Product Development

• Issues faced at different phases of development
• The need to agree the specific product type required
• Medicinal product production, scale up from development to production batches
• Process validation requirements for different dosage forms
• Stability programmes and data requirements
• When/how to deal with changes during development to ensure this does not invalidate any of the clinical/other data already generated.
• Specific data requirements for and issues associated with different
• Variations

Regulatory Agency’s Perspective on the Medicinal Product Section of Marketing Authorisation Applications (MAAs)

• Potential pitfalls and practical issues experienced with the medicinal product section of an MAA
• An agency perspective on common findings arising during regulatory review for a range of product formulations
• Current experience and advice on preparation and presentation of the medicinal product section of the CTD
• Quality Overall Summary – what reviewers want to see

Also available as a one-day course. Ref: CMC-2