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Regulatory Affairs Portal

This one-stop resource provides you with the comprehensive knowledge resources in regulatory affairs to help you develop skills and learn proven strategies and techniques to help you overcome the challenges you face in your profession.

This resource center addresses all of today’s hottest topics, including:

  • US and European regulatory affairs
  • Preparing for FDA meetings 
  • Post-approval regulatory requirements 
  • Regulatory requirements for product labeling & advertising 
  • Biologic products
  • Regulatory strategy
  • Quality assurance 
Meetings
   
NA_15002 Pharmacovigilance and Risk Management Strategies 2015
January 26-28 | Washington, DC
NA_15009 Joint Adaptive Design and Bayesian Statistics Conference: Drivers of Efficiency in Modern Medical Product Development
February 10-12 | Arlington, VA
NA_15007 Marketing Pharmaceuticals 2015
February 15-19 | Washington, DC
NA_15006 Medical & Scientific Communications 2015 Annual Forum
March 16-18 | Glendale, AZ
NA_CMC CMC Workshop 2015
April 13-15 | Bethesda, MD
NA_15008 DIA/FDA Statistics Forum 2015
April 20-22 | North Bethesda, MD
NA_15003 eRegulatory and Intelligence Annual Conference
May 11-13 | Philadelphia, PA
NA_15002 DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.
June 14-18 | Washington, DC
   
In-Person Instruction
   
Training Stay Tuned for Upcoming Offerings
   
Online Learning
   
Webinar Proarrhythmia
November 19
Webinar Impact on Drug Development of Novel Translational Safety Biomarkers for Improved Detection of Drug-Induced Acute Kidney Injury
November 20
Webinar Target Product Profile
December 2
Webinar Facets of Drug-Induced Kidney Injury and Regulatory Perspective
December 3
Webinar Implementation and Status of Periodic Benefit-Risk Evaluation Reporting (PBRER) in Canada
December 9
Online Training Art of Writing a Clinical Overview
February 25-26
Online Training How to Prepare for a Safety Inspection
June 1-3
   
Resources
   
eLearning
View complete catalogue of eLearning Modules. 
   

Get the Big Picture of DIA’s Training Offerings:



What is Regulatory Science?

Listen to top FDA officials and scientists explain the fields of research that make it possible for FDA to fulfill its mission of protecting public health.