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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
   
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
15005 Clinical Trial Disclosure & Data Transparency – The Expanding Global Environment
September 17-18 | Bethesda, MD
NA 15014 Drug and Device Combination Products 2015: Navigating Regulation, Enhancing Collaboration, and Accelerating Development
September 28-29 | Bethesda, MD
NA 15015 Companion Diagnostics
September 30-October1 | Bethesda, MD
15020 Central Audit Methods for Site Image Interpretation in Clinical Trials
October 1-2 | North Bethesda, MD
15017 Achieving Meaningful Regulatory and Clinical Outcomes for Patients: Strategies in Rare Disease Therapy Development
October 7 | Bethesda, MD
NA 15012 Biosimilars
October 19-20 | Bethesda, MD
15019 DIA Annual Canadian Meeting 2015
October 27-28 | Ottawa, ON, Canada
16002 Pharmacovigilance and Risk Management Strategies 2016
January 25-26 | Washington, DC
16006 Medical and Scientific Communications 2016 Annual Forum
March 21-23 | Kissimmee, FL
   
In-Person Instruction
   
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 European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations
August 11-12 | 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 21-22 | Washington, DC
Training Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
September 28-30 | Toronto, Canada
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 A New Era of Open Dialog and Communication: The Impact of FDASIA, PDUFA V, and Critical Path Innovation Meetings
June 24
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.