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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
   
14022S Global Labeling 2014: Compliance in a Changing Regulatory Environment
April 9-10
Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline Drug-Induced Injury of Liver, Heart, Kidney, and Skin: Employing Recent Advances to Improve Patient Safety and Speed Up the Pipeline
May 7-9 | Bethesda, MD
Data Monitoring Committees: Best Practices and Future Directions DIA 2014 50th Annual Meeting “Celebrate the Past - Invent the Future”
June 15-19 | San Diego, CA
   
In-Person Instruction
   
Training Regulatory Affairs: The IND, NDA, and Postmarketing
March 16-19 | Irvine, CA
Training Pragmatic Approaches to Drug Safety Across the Premarketing and Postmarketing Continuum
April 2-4 | Horsham, PA
Training Global Considerations for Regulatory Strategy Development
April 15-16 | Horsham, PA
Training Key Considerations for the Development and Marketing of Biosimilar Products
April 24-25 | Horsham, PA
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 Overview of Drug Development
September 15 | 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 | Horsham, PA
Training Clinical Statistics for Nonstatisticians
September 15-16
Training Global Considerations for Regulatory Strategy Development
September 15-16
Training Regulatory Affairs for Biologics
October 19-20, 2014 | Irvine, CA
Training Postmarketing Drug Safety and Pharmacovigilance
October 20-21, 2014| Horsham, PA
Training Risk Management and Safety Communications
November 10-11, 2014
Training Regulatory Affairs: The IND, NDA, and Postmarketing
November 10-13, 2014
   
Online Learning
Online Training Fundamentals of Project Management for Nonproject Managers
March 19-20 & 26-27
Webinar Seven-Part Pediatric Drug Development Webinar Series: Part I: Overall Challenge: The Vision of Better Medicines for Children
April 15
Online Training Basics of the IND
April 29-May 1 & May 6-7
Online Training How to Prepare for a Safety Inspection
May 6-8
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part II: Regulatory Framework
May 20
Online Training Basics of the NDA
May 20-22 & 28-29
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part III: Regulatory Framework EU
June 10
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part IV: Dosing in Children
July 08
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 Seven-Part Pediatric Drug Development Webinar Series - Part V: Technical Development: Pediatric Formulations
August 12
Webinar Seven-Part Pediatric Drug Development Webinar Series - Part VI: 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 Seven-Part Pediatric Drug Development Webinar Series - Part VII: Operational Challenges of Pediatric Clinical Trials
October 14
   
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.