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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
Training Courses
   
Regulatory Affairs Paediatric Investigation Plans (PIP)
13-14 May 2014 | London, UK
Regulatory Affairs New Course! Essentials of European Regulatory Affairs
23-24 June 2014 | Amsterdam, the Netherlands
   

 
Resources
   
eLearning
View complete catalogue of eLearning Modules. 




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.