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.

This audio conference covers:

• Descriptions of the relevant procedures, regulations, and guidelines
• The incentives for companies to develop ATMPs
• The interaction between the different ATMP legislations
• CMC/quality requirements
• CMC/quality issues

About the speaker:

Dr. Elliot Lawrence is an Associate Director at ERA Consulting (UK) Ltd. ERA is one of the longest established and most experienced consulting groups serving the biopharmaceutical industry. Elliot specializes in quality (CMC) aspects of biological products, particularly advance therapy medicinal products. Before joining ERA Elliot gained eight years of experience in biotech product development and is an Ex-HTA and HFEA Inspector with broad experience of assessing compliance against legislation and good practice standards (GMP & GLP), including the area of human tissue and cells for human application (GTP). Elliot completed a PhD in Molecular Microbiology at the Royal London Hospital, Queen Mary and Westfield College, before moving to the biotech industry and joining ERA in mid-2008.

Who should attend?

• Regulatory Affairs Directors and Managers
• Project and Business Development Managers
• Senior Management
• Development Team Members
• Pharmaceutical Industry Investors