Whitepapers / Publications

Whitepapers

• Pediatric Exclusivity and Drug Development Requirements in the Overall Pediatric Population
  32 Kb
• The Regulatory Paradox of Laboratory Developed Tests
  39 Kb
• Outsourcing: A Rapid, Cost-Effective Option for Electronic (eCTD) Submissions
  47 Kb
• Preparing for Mandatory Electronic Submission of Drug Establishment Registration and Drug Listing Information
  39 Kb
• The U.S. FDA Orphan Drug Product Program
  36 Kb
• Evaluating the Electronic Submissions Challenge in the Pharma and Biotech Industries
  36 Kb
• Risk Evaluation and Mitigation Strategies (REMS) under FDAAA
  31 Kb

Publications

• Meeting Report – DIA Conference on EDM and eCTD – February 2009
  147 Kb
• Meeting Report – 7th Annual DIA Conference on eCTD – November 2008
  145 Kb

Audio Conference Slides

• Electronic (eCTD) Submission Myths – September 2009
  471 Kb
• API Drug Development – August 2009
  330 Kb
• Optimizing Your CMC Program – June 2009
  324 Kb
• Lifecycle Management of the eCTD and NeeS in Europe – April 2009
  878 Kb
• Electronic Submissions in Europe – eCTD and NeeS – January 2009
  406 Kb