Course description
Getting the CMC Dossier Right
You will be provided with an update on the latest scientific requirements, an insight into the data requirements and common regulatory issues for substance and drug product. You will hear from a Regulatory Authority on 'how to get it right the first time', including potential pitfall areas; what makes a good quality summary and practical issues in the presentation of Module 3 of Marketing Authorisation Applications. You will also have the opportunity to take part in case studies to illustrate lessons learned.
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Suitability - Who should attend?
Suitable for
- Less experienced regulatory professionals who require comprehensive information on CMC (Synthetic molecules)
- Experienced professionals who are newcomers to CMC (Synthetic molecules)
- Anyone who wishes to update their knowledge in CMC(Synthetic molecules)
Outcome / Qualification etc.
Benefits to participants
- Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier
- Participate in case studies and interactive lessons - learn by doing
- Have the opportunity to interact with speakers from Regulatory Agencies in a neutral environment
- Meet and learn from experts in the field
- Build a network to support the rest of your career
- Learn the common pitfalls to avoid
- Take a course developed by professionals for professionals with a proven track record.
Training Course Content
Day 1 Programme: Drug Substance
- Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘S’
- Control of Drug Substances
- Data Requirements and Practical Guidance for Drug Substance Development
- What’s so different about Biotech CMC
- Regulatory Agency’s Perspective on the Drug Substance Section of Marketing Authorisation Applications (MAAs)
Day 2 Programme: Drug Product
- Data Requirements and Practical Guidance for Medicinal Product Development
- Introduction to Preparing the Perfect Common Technical Document (CTD) Module 3 Part ‘P’
- Control of Medicinal Product
- Regulatory Agency’s Perspective on the Medicinal Product Section of Marketing Authorisation Applications (MAAs)
- Introduction and Preparation for the Case Study
Expenses
The full tuition price for Members is 925 GBP. The price for Non-members is 1095 GBP
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