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CONFERENCES AND TRAINING

Gain unique insight from FDA on Medical Device Submission and Compliance Strategies for US, 12-13 April 2010, Rockville, MD. Find out more »

2010 SCOPE OF PRACTICE SURVEY

Please complete the 2010 RAPS Scope of Practice & Compensation Survey and encourage your colleagues to take it. If we get 4,000 responses, every participant will get a free copy of the resulting report. Find out more »

Health & Regulatory News

FDA Goes on the Road to Promote Orphan Drug Development
In an effort to encourage the development of drugs for rare diseases, FDA has begun a series of workshops to provide regulatory advice for potential drug sponsors. Read more »

German Health Minister to Propose Drug Price Controls
In a move to save on healthcare costs, Germany’s health minister intends to compel drugmakers to negotiate lower prices directly with insurers. Read more »

More Health & Regulatory News »

REGULATORY FOCUS

An update on the harmonization activities of GHTF, ISO, ICH and WHO, plus such regional agreements as NAFTA, ASEAN, MERCOSUR and MRAs for all products types, as well as current labeling initiatives in Europe under Article 30 and the impact of trade agreements on regulatory and import and export.

RAPS BOOKSTORE

Fundamentals of US Regulatory Affairs, Sixth Edition is now available. Comprised of entirely new content from more than 40 renowned experts in the profession, the expanded new editon is the most complete US regulatory reference tool available today.