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ATMP Regulations- Digital Recording (June 17 2013)

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Description
ISCT Webinar: ATMP Regulations
Organized by the EU Regional Leadership Committee 


Date: June 17th, 2013

Time: 6:00 AM Pacific, 9:00 AM Eastern, 4:00 PM CET (Europe)

Chair: Stefan Scheding, MD, Lund University, Sweden

Speakers: Martin Hildebrandt, MD, Technische Universität München, Germany and  Anne Dickinson, PhD, New Castle University, United Kingdom

 About the Webinar:

"Advanced Therapy Medicinal Products (ATMPs) are medicinal products of human use, based on gene therapy, somatic cell therapy or tissue engineering. A repidly growing area in translational research, they represent the "next generation" of complex medicines for complex diseases and pose particular challenges to medicines regulation.

Regulation (EC) No 1394/2007 has been designed to ensure the free movement of ATMPs within the European Union (EU), to facilitate their access to the EU market and to foster the competitiveness of European pharmaceutical companies while guaranteeing the highest level of health protection for patients.

This webinar will provide information on current ATMP regulations with a special focus on ATMPs in academic environments."

Learning Objectives:

1) To learn the basic criteria used to define ATMPs and the challenges inherent in this definition of innovative and complex medicines

2) To become familiar with the classification, certification and marketing authorisation of ATMPs

3) To explore pathways for first-in man applications of ATMPs, including the Hospital Exemption Clause and alternatives

4) To learn about the differences in ATMP regulation implementation in the member states

 

5) To understand what characteristics are linked with "success” in ATMP production and development in academic environments

 

6) To learn about academia’s perception if and how the ATMP Regulation 1394/2007/EC has hindered innovation