is being presented by Dr. Gavin Edwards, Senior Consultant, with ERA Consulting (UK) Ltd and airs on Tuesday, October 12th, 2010. For more details or to register, please visit our site at www.fxconferences.com
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.
Showing posts with label CHMP. Show all posts
Showing posts with label CHMP. Show all posts
Monday, September 13, 2010
Monday, January 25, 2010
Achieving Global Registration of Complex Biosimilars
Similar biological medicinal products (biosimilars) became a reality in Europe when the CHMP adopted positive opinions for the two human growth hormones Omnitrope and Valtropin. Since then, more than ten marketing authorization applications for biosimilar products have been approved. However, there have also been failures. Currently, there are biosimilar products being developed for the more complex biopharmaceuticals such as monoclonal antibodies, and soon those will be submitted for registration.
This audio conference details the relevant regulatory procedures, regulations, guidelines and regulatory experience to date with complex biosimilars. The speaker identifies and discusses the challenges (CMC, non-clinical and clinical) concerning the demonstration of biosimilarity for complex biosimilars, and proposes possible global development plans.
Achieving Global Registration of Complex Biosimilars is being presented by Robert Blakie, Director & General Manager, with ERA Consulting (UK) Ltd. and airs on Thursday, February 25, 2010. For more details or to register, please visit our site at www.fxconferences.com
This audio conference details the relevant regulatory procedures, regulations, guidelines and regulatory experience to date with complex biosimilars. The speaker identifies and discusses the challenges (CMC, non-clinical and clinical) concerning the demonstration of biosimilarity for complex biosimilars, and proposes possible global development plans.
Achieving Global Registration of Complex Biosimilars is being presented by Robert Blakie, Director & General Manager, with ERA Consulting (UK) Ltd. and airs on Thursday, February 25, 2010. For more details or to register, please visit our site at www.fxconferences.com
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