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Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
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Pre-Con Workshop Day (27th April 2026) - CET/CEST (Cent Europe Summer, GMT+2)
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Workshop 1: CMC Roadmap
09:00 - 10:30
Section 1: CMC and the Development Cycle
1.1 Introduction to Drug Regulation
1.2 The Drug Development Cycle
1.3 Quality by Design
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
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Workshop 1: CMC Roadmap
11:00 - 11:30
Section 1: CMC and the Development Cycle
1.4 Guidance
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
11:30 - 12:00
Section 1: Q&A and Quiz
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
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Workshop 1: CMC Roadmap
13:00 - 14:30
Section 2: CMC Activites from Pre-Clinical to Phase 2
2.1 First Overview
2.2 Dealing with Changes
2.3 Control of Adventitious Agents
2.4 Cell Banks and Raw Materials
- Margit Holzer - Scientific Director, Ulysse Consult
- Thomas Chattaway - Senior Life Science Consultant, Independent
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Workshop 1: CMC Roadmap
14:30 - 16:00
Section 2: CMC Activites from Pre-Clinical to Phase 2
2.5 Process Development and Design
2.6 Development of Analytical Methods
2.7 Formulation and Stability
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
16:00 - 16:30
Section 3: Moving Forward and Conclusions
3.1 What happens after Phase 2?
3.2 Q&A and Conclusions
- Thomas Chattaway - Senior Life Science Consultant, Independent
- Margit Holzer - Scientific Director, Ulysse Consult
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