Biotech 2012 - Conducting EU Studies from a US Virtual Biotech Company

This webinar will cover the regulatory requirements, challenges and opportunities in extending clinical trials to European Union countries by a virtual pharmaceutical or biotech company.

Why Should You Attend:

There are unique challenges and opportunities in conducting clinical studies in (or extending existing ones to) the EU by a virtual pharmaceutical or biotech company. The challenges are in understanding the mechanism and process of application both centrally and in each individual state and the steps necessary to recruit sites and commence enrollment.

Areas Covered in the Seminar:
- Applicable European Regulations for Initiating and conducting clinical studies in the EU.
- European regulations for submitting expedited and periodic safety reports.
- Clinical material requirements.
- Regulations (and necessary infrastructure) for importing the test and comparison articles and other clinical supplies in the EU.
- Insurance requirements.
- Filing requirements in individual states.
- Monitoring of clinical trials in the EU.
- Transport and testing of tissue samples.
- The role of Institutional and regional Ethics Committees in the EU.