Advanced CMC Masterclass - EU edition

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex.

TBA, Virtual
Time Zone: UTC/GMT+1 /CET

Overview

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, and the products themselves are becoming more and more complex. This course will present key points in CMC which are currently the focus of Health Authorities, and which are critical for the successful development, registration, and lifecycle of pharmaceutical products. The course covers general requirements for small molecules and biologics.
 

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RECOMMENDATION

Who should attend?

Quality assurance specialists
Regulatory Affairs CMC authors or reviewers
Analytical and stability laboratory (R&D through GMP)
Project managers with CMC responsibilities
Chemistry, Manufacturing & Controls (CMC) regulatory
Product scientists and test method technical experts (R&D and QC)
Process analytical chemists and process development scientists