1. MSc Clinical Research Module 8: Assignment

2. “There is no effective regulation of post marketing clinical studies” True of False?

3. Learning Objectives This assignment has been designed to fulfil the following objectives Understanding the important and changing landscape of post marketing studies Determining whether the belief they are unregulated is, or ever has been true Summarising the approaches in Euope and the US Critically evaluating the regulatory approach to these studies in Europe and the US.

4. Post Marketing Studies Post marketing studies are vital to provide information about a drug following marketing approval They provide information about the drug when used un a larger more varied population than can ever be obtained in clinical research They are of value to the industry, the regulator and increasingly payers in the Healthcare sector.

5. FDA The FDA regulatory framework around post marketing studies has recently changed. Information on this can be found at: http://www.fda.gov/downloads/Drugs/GuidanceCompl ianceRegulatoryInformation/Guidances/UCM172001. pdf

6. Europe The European medicines Agency has several documents available to assist users at: http://www.ema.europa.eu/ema/index.jsp?curl=pages /regulation/document_listing/document_listing_00009 0.jsp&murl=menus/regulations/regulations.jsp&mid= WC0b01ac0580023398&jsenabled=true

7. The Assignment You have been asked by your manager who is new to the Post Marketing Arena with no knowledge of its regulation to: Introduce him to the importance and historical development of post marketing studies Evaluate and summarise the current approach in Europe and the US to these studies Identify the difference between and importance of experimental and observational studies Critically evaluate the approaches, highlighting major differences and pointing out the advantages and disadvantages of both.

8. Marking scheme Historical perspective 10% Summary of US approach20% Summary of European Approach20% Importance of Observational and 10% Experimental approaches Critical evaluation of different approaches 30% Presentation and referencing 10% Total100%

9. Submission Submission is in the for of a written briefing to the new manager not exceeding 3000 words Date for final submission is Monday 13 February 2012