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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_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
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
   
In-Person Instruction
   
Training Regulatory Affairs: The IND, NDA, and Postmarketing
March 15-18 | Irvine, CA
Training Premarketing Clinical Safety and Pharmacovigilance
March 23-23 | Washington, DC
Training Preparing for a FDA Advisory Committee Meeting
March 30 | Washington, DC
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 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 15-16 | 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 Regulatory Aspects of Prescription Drug/Biologics Advertising and Promotional Labeling
February 5
Webinar Clinical Trials Transparency 3 Part Webinar Series - Part 3: Understanding the Legislation Landscape: Regulatory Updates from the FDA, EMA and Health Canada
February 10
Online Training Art of Writing a Clinical Overview
February 25-26
Webinar Pricing, Economic, Reimbursement, Market Share (PERMS) Strategy: An Interactive Holistic Approach in Rare Diseases
March 5
Online Training Preparing a Clinical Trial Budget
March 10
Online Training Basics of the IND Phase
May 4-7
Online Training Basics of the NDA Phase
May 18-21
Online Training How to Prepare for a Safety Inspection
June 1-3
Online Training Adverse Event Reporting Requirements: IND and Post-marketing
July 13-15
Online Training Interactions with the FDA during IND/NDA Phases
July 16
Online Training Overview of Drug Development in Japan
September 2-3 & 9-10
   
Resources
   
eLearning
View complete catalogue of eLearning Modules. 
   

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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.