ComplianceOnline

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. In addition, there are unique challenges in monitoring these studies and maintaining regulatory compliance during their conduct phase. Despite these challenges, there are unique opportunities for a virtual (or any) company in this setting; There is a wide pool of talent available to supplement the knowledge base and capabilities of the company as well as the opportunity of including in the study a diverse population of 27 different nations, accelerating enrollment and meeting aggressive deadlines.

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.

Learning Objectives:

Understanding the process required for initiating and conducting a clinical study in the countries of the European Union.

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.

For Registration:

 http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702287?channel=hummolgen