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Global Drug Development Workshop

posted Sep 10, 2010, 1:41 PM by Dennis Harris

Hosted by the Hopkins Biotech Network (website)


CRB2 room 111, behind Me Latte
1550 Orleans St, Baltimore, MD
Saturday Oct 2nd, 2010 | 9:30 AM - 3:30 PM
Map | Register
Whether you are writing a business plan or would like to consider a career in private industry after graduation, this workshop will get you off to a great start! Join Haroon Hashmi from Biogen Idec and Dr. Barbara Slusher from Johns Hopkins University to learn about the latest global drug development strategies. 

AGENDA
9:30-10AM
  Breakfast and Introductions
10-12PM  Overview of Drug Development
Pre-Clinical Phase: Defining the product, Assessing commercial value, non-clinical testing, Manufacturing, Agency interactions

12-1PM  Lunch
1:00-3PM 
Clinical Trial Phases: Investigational New Drug applications, Sponsor obligations, Investigators and IRBs, Research ethics, Safety reporting, Objectives and phases of clinical trials
Product designations: Orphan drugs, FDA Fast Track, Pediatric studies initiative
The Approval Process: Marketing application, FDA meetings, Labeling negotiations
Post Approval: Marketing, Monitoring, and Life cycle management
3-3:30 PM  Career opportunities for Life-scientists in the Biotech industry

** Please note that there may be a small amount of pre-work or reading associated with this workshop.** 
Each registrant will receive an e-mail during the week prior to the workshop with any updates. 
Sponsors: HBN; Carey Business School; JHU Brain Sciences Institute; The JHMI Postdoc Association
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