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Date: 27th May, 2008

Location: web seminar, USA

Summary:
Clinical, Pharmaceutical - Training, Seminar

As of May 2004, dramatic changes were made to the procedures, requirements and responsibilities for sponsors wanting to conduct Clinical Trials in the current 30 countries of the EU (European Economic Area). It is now essential for potential sponsors, CROs and anyone closely associated with conducting trials on European soil to understand the relatively new legal requirements which continue to undergo modifications. Since the legal instrument is a directive and not a regulation, each country is allowed to use the directive as a set of minimum requirements and also impose other requirements for sponsors running trials in their Member State.

This live course will focus on understanding the country requirements of the new EU Clinical Trial Directive, as well as the issues inherent in any new regulatory process. The course will cover all relevant topics associated with the Directive, the reasons behind its introduction and a review of methods for effective implementation. In addition, understanding the strategy of where to run clinical trials, depending on where you intend to market your product will be covered in detail. The best countries to consider when running clinical trials will also be discussed, along with the reasons why.

Key Discussion Points will include:

• EU Agencies and Competent Authorities Reporting Structure
  
• Overview of Key Areas of the Clinical Trial Directive
  
• Strategy: Linking Clinical Trial Locations with Marketing Authorization Filings
  
• Implementing Trials Under The EUCTD / Guidance Documents Understanding
  
• Importance of EU GMP and GCP
  
• EU Inspections
  
• Trial Sponsor's Responsibilities
  
• Roles / SOPs
  
• Comparing & Contrasting FDA IND Process vs. EUCTD
  

Learning Benefits - Upon completion of this course, participants will:

• have a thorough knowledge of the EU Clinical Trial Directive requirements
  
• understand the regulatory structure in the EU, who reports to whom and where the 'court of appeals" process lies.
  
• be taking a totally different strategy understanding back to trial project teams
  
• bring efficiency in conducting trials in the EU back to project teams
  
• be more comfortable in talking directly with the EU Competent Authorities
  
• understand the guidance documents provided to trial sponsors
  
• have a better understanding on "how" to work with the EU Regulatory Community