Date: February 11, 2016, 3:00 p.m. EST
By Christina Vessely, PhD
The biopharmaceutical product development lifecycle often requires the transfer of a manufacturing process from one facility to another. These transfers can occur at any point along the development path, and may be driven by increases in material needs to support clinical studies or the commercial market. Demonstration of analytical product comparability between sites will decrease the likelihood of a regulatory agency (whether it be the FDA, EMA or another entity) requiring clinical and/or DMPK studies to support the transfer of a manufacturing process.
For biopharmaceutical companies of all sizes, a thorough understanding of the regulatory expectations and the development of a plan to address the regulatory requirements involved in facility process transfer is essential to avoid delays, additional studies and unnecessary costs.
This webinar will guide participants through the latest Agency thinking and Industry standards for the following:
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Christina Vessely, Ph.D. is a Senior Consultant at Biologics Consulting with over 18 years of experience in analytical and formulation development within the biotechnology industry. Her experience ranges from early stage research and development for small and start-up firms through late stage development and commercialization for mid-sized and large pharmaceutical companies. She has been involved in priority review and/ fast track programs and has participated in pre-approval inspections (PAI) and PAI-enabling activities including the design and execution of validation studies and evaluation of GMP systems as well as authoring and editing of analytical sections for multiple filings in both the U.S. and in the EU (IND/IMPD, BLA/MAA).
The Expert Edge Webinar Series was created by Biologics Consulting in an effort to share the latest Agency guidance and best practices with leaders throughout the biopharmaceutical and medical device industries. Each interactive, web-based workshop in the series is hosted by an accomplished subject-matter expert and designed to provide participants with a pathway to success through some of the most complex regulatory and product development challenges in the Industry today.