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.

9-10 Apr 2014 at Radisson Blu Edwardian Grafton Hotel, London, GB

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

From: April 09, 2014 09:00
To: April 10, 2014 17:00

Radisson Blu Edwardian Grafton Hotel, 130 Tottenham Court Road, W1T 5AY, London, GB


Pharmaceuticals/Drug Discovery, Health & Fitness

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+44 (0) 20 7017 7481

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