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IIR PTI
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Mon 12 Apr 2010
- Tue 13 Apr 2010
Regus St. James's Park, London, England
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Tue 17 Aug 2010
- Wed 18 Aug 2010
Regus Trafalgar Square, London, England
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Process changes made during the manufacture of recombinant proteins can have profound implications on the quality, safety, efficacy and regulatory approval of your product.
This 2-day course gives you a practical insight into how to manage process change so as to ensure regulatory compliance and product consistency at all times. With more than 20 industry case studies to work on, this course is your ultimate guide to finding the best ways to satisfy the needs of the regulators and understand how various process changes may impact the success of your product.
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Who Will Attend?
Those working in:
Manufacturing
Regulatory
Quality Personnel
Project Management
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Don't Miss
- Discuss the latest regulatory changes and ensure you meet the needs of the regulators
- Gain insight into the inter-relationship between process change, quality, safety and efficacy
- Explain the potential significance of change control, Good Manufacturing Process (GMP) and the potential of Process Analytical Technology (PAT)
- Discuss the potential significance of various process changes and how these may impact the quality of the product
- Explain the physico-chemical and biologicals tools available to monitor the impact of process change
- Outline the non-clinical and clinical testing programs that might be required to support major process change
- Compare and contrast the EU and US regulatory agency position
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Course Leader
CECIL NICK
A regulatory professional with over 20 years experience, Cecil Nick joined PAREXEL in February 2001 and has been involved with drug development and biotech, NCE and orphan drug submissions. He has also authored many articles published in Regulatory Affairs Journal and GCP Journal, which most recently include on Biocomparabilty and Biogenerics.
SIEGFRIED SCHMITT
Dr Siegfried Schmitt is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International. He joined PAREXEL Consulting in July 2007 after 18 years experience in the healthcare industry. In his current position, Dr Schmitt provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems. Dr Schmitt is also an accomplished auditor, covering good practices and compliance for systems, facilities and operations.
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