Advanced CMC - US edition MasterClass

This Masterclass will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC, and also this training covers general requirements for small molecules and biologics.

25-26 September, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

Technical and regulatory requirements for developing a medicinal product are becoming stricter every day, the products themselves become more and more complex. This course will go through the key scientific points for the development and registration of your medicine, and provide a focus on US FDA and Europe expectations for CMC.

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 managers (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