CONFERENCES AND TRAINING

Advanced eCTD Submissions

Get hands-on training preparing an eCTD application in the development phase and repurposing the content for submission to multiple regulatory authorities. Also covered will be the challenges and benefits of using document granularity over a drug submission's lifecycle. Find out more »		    

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RAC

Whether you work in pharmaceuticals, medical devices or biotechnology, the RAC credential can help you stand out from the competition. Registration is open for the spring 2010 RAC exam window. Find out more »

 
Health & Regulatory News

EU-India Free Trade Talks Criticized
Free trade talks between the EU and India resumed last week in Mumbai, but critics in India have complained about a lack of transparency and rumored proposed pharmaceutical patent terms. Read more »

  

FDA Moves Authority for Radiology Devices to OIVD
FDA has moved its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety in an effort to effect more cohesive policies on diagnostic device review. Read more »


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REGULATORY FOCUS

February 2010 articles compare and contrast requirements for medical device registration and clinical trials in global markets.

    

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.
 
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