Advanced CMC - EU edition MasterClass

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

05-07 September, 2023, Virtual

Time Zone: UTC/GMT+1 /CET

Overview

Advanced CMC Online training will present Technical and regulatory requirements for developing a medicinal product which are becoming stricter every day, the products themselves become 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 a successful developement, 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

• Project managers with CMC

• Chemistry, Manufacturing & Controls (CMC) regulatory

• Product scientists and test method technical experts (R&D and QC)

• Process analytical chemists and process development scientists