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The Investigational Medicinal Product Dossier (IMPD): EU's CTA vs. FDA's IND

 
  June 05, 2012  
     
 
ComplianceOnline, Online Event
2012-06-15


Why Should You Attend:

All sponsors, CROs, Sites and auditors of Clinical Research who are involved in pharmaceutical or biological development need to possess the knowledge and be efficient in completing successful applications for their studies. Knowing what is expected of you and “getting-it-right” the first time, will allow faster development of innovative products.

This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.

Agenda: (All time in EDT):

  • 12:45 pm EDT Sign into Webinar
  • 1:00 pm to 2:30 pm Course Delivery
  • 2:30 to 2:45 pm (Break)
  • 2:45 pm Q&A Session
 
 
Organized by: ComplianceOnline
Invited Speakers: Robert J. Russell , is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.
 
Deadline for Abstracts: 2012-06-15
 
Registration:
For Registration:
 
E-mail: referral@complianceonline.com
 
   
 
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