Conducting EU Studies from a US Virtual Biotech Company 2012 is a webinar that covers topics such as:
- European regulations for submitting expedited and periodic safety reports
- Applicable European Regulations for Initiating and conducting clinical studies in the EU
- Regulations (and necessary infrastructure) for importing the test and comparison articles and other clinical supplies in the EU
- Clinical material requirements
- Filing requirements in individual states
- Insurance requirements
- Transport and testing of tissue samples
- Monitoring of clinical trials in the EU
- The role of Institutional and regional Ethics Committees in the EU
Conducting EU Studies from a US Virtual Biotech Company 2012 brings together:
- QA Directors/Managers/Associates
- Senior Management in Operations
- Clinical Research Associates and Coordinators
- Clinical Project Directors and/or Managers
- Regulatory Affairs Managers and Associates
