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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
   
molecules DIA Biosimilars 2014
September 18-19 | Washington, DC
folder EDM and ERS 2014
September 22-24 | Washington, DC
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_14024
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
   
In-Person Instruction
   
Training Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
August 18-20 | Horsham, PA
Training Regulatory Affairs: The IND, NDA, and Postmarketing
August 18-21 | Horsham, PA
Training Clinical Project Management
August 18-19 | Horsham, PA
Training New Drug Product Development and Life Cycle Management
August 18-19 | Horsham, PA
Training European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations
August 18-19 | Horsham, PA
Training Project Risk Management
August 20-21 | Horsham, PA
Training Overview of Drug Development
September 8 | Horsham, PA
Training Key Considerations for the Development and Marketing of Biosimilar Products
September 9-10 | Horsham, PA
Training Development of a Clinical Study Report
September 15 | Rockville, MD
Training Clinical Statistics for Nonstatisticians
September 15-16 | Rockville, MD
Training Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets
September 15-16 | Rockville, MD
Training Regulatory Affairs for Biologics
October 19-20, 2014 | Irvine, CA
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 Seven-Part Pediatric Drug Development Webinar Series - Part 4: Dosing in Children
July 8
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 1: Fundamentals of Clinical Pharmacology: Pharmacokinetics
July 10
Online Training Advanced Clinical Statistics for Nonstatisticians
July 15-17 & 22-23
Online Training Adverse Event Reporting Requirements: IND and Postmarketing
July 22-24
Webinar Pharmacovigilance and Global Harmonization Updates
July 21
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 2: Fundamentals of Clinical Pharmacology: Pharmacodynamics
August 7
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part 5: Technical Development: Pediatric Formulations
August 12
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology For Drug Development - Part 3: Principles of Modeling and Simulation
September 4
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part 6: Pre-clinical Toxicology & Safety
September 9
Online Training Art of Writing a Clinical Overview
September 9-11
Online Training Strategies for Good Clinical Practice Audits
September 23-24 & September 30-October 2
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 4: Determining the Safe First Human Dose
October 9
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part 7: Operational Challenges of Pediatric Clinical Trials
October 14
Webinar Five-Part Series on Fundamentals of Clinical Pharmacology for Drug Development - Part 5: Assessment of QT Prolongation
November 6
   
Resources
   
eLearning
View complete catalogue of eLearning Modules. 
   

Get the Big Picture of DIA’s Training Offerings:

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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.