CMC Analytical, Comparability and Stability Studies

PTI's CMC training course will provide a comprehensive overview of the phase-specific requirements for CMC analytical characterization, comparability.

Pharmaceuticals/Drug Discovery, Health & Fitness

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To provide attendees with a clear, concise, but comprehensive overview of all relevant regulatory, technical and quality elements necessary to assure successful design, implementation and documentation of the required CMC analytical and stability studies for biotechnology products, including emerging biosimilar products. Key deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented.

Attendees will be given a CD containing a complete set of all regulatory documents and industry white papers currently applicable to biotechnology product analytical CMC requirements that covers the entire product development lifecycle.

Category: Conferences | Science, Health & Medicine | Pharmaceuticals

Book before 12th March 2014: £1395 + 20% VAT = £1674
Book after 12th March 2014: £1495 + 20% VAT = £1794