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EU Clinical Trials Directive

Course Objectives

The practical effects of the Clinical Trial Directive 2001/20/EC regulations are widespread and on-going. What impact is the Directive having on your clinical trials? Are you losing valuable time seeking clarification? This intensive 2-day interactive training course has been designed to help you meet the challenges of the EU Clinical Trials Directive head-on.

Performance & Knowledge Objectives of this Course:

• Gain a clear overview of the objectives of the EU Clinical Trials Directive

• Clarify how the Directive works in practice: Understanding the impact on your business

• Devise practical strategies for compliance

• Pinpoint where the Directive is open to interpretation by national agencies

• Prepare for site inspections under the new Directive

Who Should Attend

• Clinical Trials Manager

• GMP Inspector

• Clinical Development Manager

• Clinical Process Manager

• Medical Advisor

• Quality Control/Assurance Manager

• Clinical Research Manager

• Scientific Affairs Manager

• GCP manager

• QC Associate

• Drug Safety Manager

• Clinical Operations Manager

• Clinical Project Leader

• Pharmacovigilance

• Statistician

• Biostatistician

• Data Manager

• Clinical Pharmacologist

• Clinical Pharmacology

• Drug Evaluation Manager

• Medical Director

• Regulatory Affairs Manager/Director/Executive

• International/Global Regulatory Affairs Manager

Reviews

"A very useful course"
Regulatory Affairs Manager
Medochemie Ltd

Download Latest Information Now

(updated 30 July 2010)

Dates and Venues

15 Apr 2010 - 16 Apr 2010

Regus Poultry, London, UK

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