Clinical Trials Articles

Responsibility for pharmaceuticals in the European Union is divided between the governments of the 27 member states* and the EU's institutions. The principal EU bodies concerned are the European Commission in Brussels and the European Medicines Agency in London.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office for Human Research Protection

Director

NIH Institutes, Center, and Divisions
Jerry Menikoff (240) 453-6900

Deputy Director and Director, Office of International Activities

Melody Lin (240) 453-8126

Associate Director, Regulatory Affairs

Michael Carome (240) 453-8237

Director, Division of Compliance Oversight

Ravi Pawa

Bringing with her over 15 years of clinical and research experience, Ravi Pawa, MB ChB, is Synexus' (Lancashire, UK) new medical advisor. Pawa previously served as the company's clinical director of the Lancashire Research Center.

David Tousley

Work-Life Notes from a Large CRO
Nov 1, 2008
By: Lisa Henderson
Applied Clinical Trials

Work-Life Notes from the FDA
Nov 1, 2008
By: Marissa Shapiro
Applied Clinical Trials

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The public's misperception of risk is one of the most important places to begin to educate the public and restore trust and confidence. The public believes largely that drugs should be free from side effects. This naïve and misinformed perception crosses over into the public's view of clinical research.

New legislation on the use of animals in experimentation looms ever larger in Europe, as officials in Brussels squabble over the final draft of a proposal to update the rules in place now for more than 20 years. There are strong pressures from animal protection groups in Europe for stricter regulation.

After four years of laying a foundation for new efforts to streamline clinical testing and drug development, leaders of the Food and Drug Administration are poised to move the agency's Critical Path Initiative (CPI) from concept to implementation.

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