Applied Clinical Trials Direct
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  October 3, 2013
In This Edition
News Roundup: FDA, CDER Weigh Organizational Changes
Articles: HIPAA/HITECH Omnibus Final Rule
Blog Posts: FDA Report: Have You Considered Patient Diversity?
Marketplace: Marketplace


News Roundup
bullet FDA, CDER Weigh Organizational Changes
bullet EMA Announces Its New Structure
bullet FDA, Research Organizations Seek to Bolster Submissions


Articles
bullet HIPAA/HITECH Omnibus Final Rule
bullet FDA and Orphan Drugs

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Blogs Posts
bullet FDA Intends to Require CDISC Standards
bullet FDA Report: Have You Considered Patient Diversity?

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Implementing a new approach to study design: what can I expect?
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Events
bullet Risk-Based Monitoring Forum

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Marketplace

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Drug Development Strategies in China
Pharma and biotech firms who are relative newcomers to the Chinese market aren't aware that the regulatory climate has changed dramatically in recent years. SFDA approval times for Clinical Trials Approvals have dropped to 7-9 months for small molecules. There are also opportunities in China for sponsors that have not yet completed Phase II trials to create a parallel approval strategy. Even without final details (like final dosing) it’s possible to file a CTA for Phase III based on the most current early phase results. This parallel submission strategy can shave several months off the final approval time in China. Read more.


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Implementing Rare Disease Registries: Unique Challenges & Proactive Solutions
Live Webinar: Wednesday, October 16, 2013 at 11:00 am EDT/ 4:00 BST/ 5:00 CEST
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Implementing Rare Disease Registries: Unique Challenges & Proactive Solutions
Live Webcast: Wednesday, November 6, 2013 at 11:00am EST
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CHINA REPORT
China is the third largest pharmaceutical market in the world and will become the second largest ahead of Japan by 2015. Everything you need to know to do business in the country; key economic sector data and exclusive interviews from regional leaders. Read More.

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Lisa Henderson
Editor in Chief
lhenderson@advanstar.com

 

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