Comparability of Recombinant Proteins Subject to Process Change: A Regulatory Perspective

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.

EU Regulatory and CMC/Quality Requirements for Advanced Therapy Medicinal Products

is being presented by Dr. Elliot Lawrence, Associate Director of Regulatory Affairs , with ERA Consulting (UK) Ltd. and airs on Tuesday, July 13th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Advanced therapy medicinal products (ATMPs) are medicinal products for human use based on gene therapy, somatic cell therapy or tissue engineering. They potentially offer new treatments for diseases and injuries of the human body. The European regulatory framework regarding ATMPs has recently changed to help facilitate free movement of ATMPs within the EU and patient access to these products, and also to foster the competitiveness of European pharmaceutical companies in the field.

This audio conference details the relevant EU regulations, regulatory procedures, and guidelines applicable to ATMPs since the changes in legislation. The speaker also discusses how the changes in the regulatory framework impact the development of an ATMP in terms of the CMC/quality requirements.

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

Regulatory Framework to Support Biomarker Development: EU & the USA

The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.

This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.

Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, please visit our site at www.fxconferences.com