Professional Training
5.0 (5 Reviews)

Introduction to EU Regulatory Affairs

PTI, Online
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Course description

Introduction to EU Regulatory Affairs

This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. After three days you will have a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators.

Through interactive exercises you will gain a practical insight into the European legal and regulatory environment, the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical approach that will enable you to apply what you have learned to your daily work.

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Suitability - Who should attend?

  • Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers
  • Those in other areas of the pharmaceutical industry such as development or manufacturing
  • Project Management who would find knowledge of the regulatory environment useful.

Training Course Content

  • Speed-up the MAA through effective selection of your drug registration procedure
  • Integrate CTD requirements from the start of your submissions
  • Gain faster responsesfrom the regulators through better negotiations
  • Compile and present the key information in your submission dossiers more efficiently
  • Maintain your license by performing post-approval obligations on time
  • Reduce early, or late stage, setbacks in the registration procedure by anticipating questions from regulators
  • Improve your dossier compilation process through a systematic data collection strategy
  • Facilitate your drug’s successful review by preparing a strong clinical profile
  • Take into consideration the patent situation when working on abridged applications

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:



Average rating 5

Based on 5 reviews.
Write a review!
Senior Academic Alliances Counsel, AstraZeneca
23 Jun 2020
Very detailed

This course provided a very detailed overview of the subject matter. I enjoyed the way the course was delivered, the knowledge and the enthusiasm of the trainer. She was a fanta...

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Analytical Operations Manager, Orchard Therapeutics
23 Jun 2020
Very helpful

I enjoyed the practical sessions. There was a clear overview of the EU regulations and it provided me with tools and guidelines to look at - very helpful.

QA Officer (Regulatory Affairs), Phamacare Premium Ltd
23 Jun 2020
Great organisation

The friendly environment and knowledge which was shared along with the resources were very helpful. Great organisation.

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