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May 2008

Editorial - Is Agency Specialisation the Future in the EU?

Improving the Efficiency of the EU Drug Regulatory System
RAJ reports on suggestions from a senior industry official.

How to Develop the Expert's Role in National Authorities
Helena Nandin de Carvalho says national authority experts need more opportunities to play a greater role in the European drug regulatory setting.

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RAJ Pharma welcomes articles from regulatory affairs professionals worldwide

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A US Industry Perspective
Alan Goldhammer and Jeff Trewhitt of PhRMA talk to Karen Finn about new regulatory requirements, DTC advertising and international harmonisation.

The Future of Medical Products Regulation: How Can Pharmaceutical Innovation be Safeguarded?
Jon Lisman suggests there are lessons to be learned from the medical devices sector.

Protocol Design Trends and Clinical Trial Performance
Kenneth Getz reports that changes in protocol design might be adversely affecting clinical trial performance.

Plus:

Swissmedic Organisational Chart
Guidelines for Human and Veterinary Medicinal Products
Meetings/Appointments
Directory of Services
Worldwide Update

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