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Introduction to EU Regulatory Affairs

Course summary
Online courses
Professional Training

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.

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:


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About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 5 reviews

Senior Academic Alliances Counsel, AstraZeneca
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 fantastic teacher and knowledge sharer.
Analytical Operations Manager, Orchard Therapeutics
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
The friendly environment and knowledge which was shared along with the resources were very helpful. Great organisation.
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Course rating
Based on 5 reviews
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