An inability to demonstrate product comparability following a process change is a common and serious error, however a well thought-out strategy for process change and the associated comparability exercise can ensure that regulatory pitfalls are avoided. In this audio conference, the speaker discusses the contents of ICH Q5E, using real-life examples to emphasize the main points. In addition, the presentation includes several case studies that illustrate the consequences resulting from a lack of comparability, for example, pure red cell aplasia associated with erythropoietin. Finally, the speaker also outlines procedures for seeking the advice of European regulators in relation to a process change.

This audio conference covers:

• The EU regulatory expectations surrounding manufacturing process changes
• The importance of product comparability pre- and post- authorization
• The consequences of a lack of comparability
• How to seek advice from a National Competent Authority
• How to seek advice from the European Medicines Agency’s CHMP

About the speaker:

Dr. Gavin Edwards earned his PhD in molecular and cellular biology working within the world renowned Tyrrell Research Group based within the Department of Pharmacy and Pharmacology, University of Bath, UK. His PhD studies primarily concerned the elucidation of the regulatory mechanisms surrounding the defense enzyme Heme Oxygenase-1 in human skin cells. After this, he spent time working within the New Product Development Group of a multinational biologics manufacturer; here much of his work involved the commercialization of a CHO cell-line capable of generating afucosyl monoclonal antibodies. Dr. Edwards is currently employed as a Senior Consultant for ERA Consulting (UK). In this role he holds responsibility for numerous multinational clients; his consulting activities are primarily focused on the development and regulation of recombinant proteins.

Who should attend?

• Regulatory Affairs Professionals
• Project Managers
• Research and Development Scientists
• Senior Management
• Biopharmaceutical Investors