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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_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 15018 DIA Canadian Pharmacovigilance & Risk Management Meeting
May 21 | Toronto, Canada
DIA Annual Meeting DIA 2015 51st Annual Meeting: Develop. Innovate. Advance.
June 14-18 | Washington, DC
DIA/FDA Oligonucleotide-based Therapeutic Conference 2015 DIA/FDA Oligonucleotide-based Therapeutic Conference 2015
September 9-11 | Washington, DC
 	Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products Patient Engagement in Benefit-Risk Assessment throughout the Life Cycle of Medical Products
September 17-18 | North Bthesda, MD
NA 15012 Biosimilars
October 19-20 | Bethesda, MD
   
In-Person Instruction
   
Training Regulatory Affairs for Biologics
April 14-15 | Bethesda, MD
Training Key Considerations for the Development and Marketing of Biosimilar Products
April 27-28 | Washington, DC
Training Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
April 29-May 1 | Washington, DC
Training Electronic Submissions: The Next Era of Electronic Submissions
May 14 | Philadelphia
Training Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets
August 3-4 | Washington, DC
Training Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
August 10-12 | Boston, MA
Training Development of a Clinical Study Report
August 10 | Boston, MA
Training Regulatory Affairs: The IND, NDA, and Postmarketing
August 10-13 | Boston, MA
Training Clinical Project Management
August 24-25 | Washington, DC
Training New Drug Product Development and Life Cycle Management
August 26-27 | Washington, DC
Training Adaptive Design in Clinical Trials: When and How to Apply
September 14-15 | Washington, DC
Training Clinical Statistics for Nonstatisticians
September 28-29 | Washington, DC
Training Risk Management and Safety Communication
October 26-27 | Washington, DC
Training Postmarketing Drug Safety & Pharmacovigilance
November 9-10 | Philadelphia, PA
Training Regulatory Affairs: The IND, NDA, and Postmarketing
November 9-12 | Philadelphia, PA
Training Navigating Chemistry, Manufacturing and Controls Through the Drug Development Process
November 9-10 | Philadelphia, PA
Training Advanced Clinical Statistics for NonStatisticians
November 11-12 | Philadelphia, PA
   
Online Learning
   
Online Training Basics of the IND Phase
May 4-7 | Online
Online Training Basics of the NDA Phase
May 18-21 | Online
Online Training How to Prepare for a Safety Inspection
June 1-3 | Online
Online Training Adverse Event Reporting Requirements: IND and Post-marketing
July 13-15 | Online
Online Training Interactions with the FDA during IND/NDA Phases
July 16 | Online
Online Training Overview of Drug Development in Japan
September 2-3 & 9-10 | Online
   
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.