CRED: CMC – Drug Substance and Medicinal Product

The Evolving Pharmaceutical Dossier

Day 1 – Drug Substance

Course content

• Information on the latest scientific and technical updates and/or requirements
• An insight into the data requirements and common regulatory issues for Drug Substances including an overview of the Drug Master File (DMF) and EU Certificate of Suitability procedures; use of pharmacopoeial monographs; issues often faced at different phases of development concerning specifications, production, validation, stability; ICH regional requirements; Active ingredient manufacturer inspections: other current issues
• A Regulatory Authority’s perspective on “how to get it right first time” including potential pitfall areas; what makes a good quality summary; practical issues in the presentation of Marketing Authorisation applications.

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

Day 2 – Drug Product

Course content

• An insight into the data requirements and common regulatory issues for Drug Products including an outline of the issues often faced at different phases of development such as specifications, production, validation, stability; specific data requirements for and issues associated with different dosage forms; ICH regional requirements, other current issues
• A Regulatory Authority’s perspective on “how to get it right first time” including potential pitfall areas; what makes a good quality summary; practical issues in the presentation of Marketing Authorisation applications.

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