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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
   
magnifying glass DIA’s Annual Canadian Meeting
October 28-29 | Ottawa, ON, Canada
NA_14016 DIA Meeting on Combination Products
October 29 | Washington, DC
NA_14009 Patient Engagement throughout the Full Spectrum of Drug Development: An Interactive Workshop for Life Science Companies and Patient Groups
October 29-30 | Washington, DC
NA_15002 DIA Meeting on Companion Diagnostics
October 30 | Washington, DC
baby Pediatric Research Conference 2014
November 6-7 | Washington, DC
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 Postmarketing Drug Safety and Pharmacovigilance
October 20-21, 2014| Horsham, PA
Training Adaptive Design in Clinical Trials: When and How to Apply
October 21-22 | Philadelphia, PA
Training Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation
November 3-4 | Washington, DC
Training Navigating Chemistry, Manufacturing & Controls Through the Drug Development Process
November 3-4 | Horsham, PA
Training Electronic Submissions: The Next Era of Electronic Submissions
November 9 | Bethesda, MD
Training Risk Management and Safety Communications Strategies
November 10-11 | Bethesda, MD
Training Regulatory Affairs: The IND, NDA, and Postmarketing
November 10-13 | Bethesda, MD
   
Online Learning
   
Webinar Clinical Trials Transparency 3-Part Series: Moving the Debate Forward-Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 2-Connecting the Research Community: Data Sharing–Perspectives from Academia and Patient Advocacy Groups
October 21
Online Training Negotiation and Influence
October 30
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation
November 6
Webinar Clinical Trials Transparency 3-Part Series: Moving the Debate Forward - Realizing the Benefits of Providing Greater Access to Clinical Trial Data: Part 3 - Understanding the Legislation Landscape: Regulatory Updates from the FDA and EMA
November 12
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 Implementation and Status of Periodic Benefit-Risk Evaluation Reporting (PBRER) in Canada
December 9
   
Resources
   
eLearning
View complete catalogue of eLearning Modules. 
   

Get the Big Picture of DIA’s Training Offerings:

"RA Resource Video"

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.