Professional Training
5.0 (2 Reviews)

Fundamentals of EU Regulatory Affairs

PTI, Online
4 weeks
4 weeks
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Course description

Fundamentals of EU Regulatory Affairs

The pharmaceutical and biotech industries are the most regulated in the world due to the nature of the product. Patient safety is central to all decisions, processes, procedures, guidance and regulations.Regulatoryagencies such as the MHRA and EMA are in place to ensure new and existing products meet stringent safety requirements. As a professional working in the sector it is important for you to fully understand the regulations

This introductory course will provide you with a grounding knowledge ofregulatoryaffairsinEurope. Over 4 weeks and 8 modules you will gain a clear understanding of theEUregulatorystructure and a solid grasp of the submission process including the standards required by the regulators.

This course will give you a practical insight into the European regulatory environment throughout the whole product life cycle including: non-clinical and clinical studies, the various submission procedures, labelling and packaging, post-MAA obligations and activities. and more.

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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

Outcome / Qualification etc.

  • Gain a complete overview of the EMA and the various types of MAAs
  • Understand the regulatory affairs throughout the product development including R&D, manufacturing, clinical trials and PV
  • Learn the procedures for gaining clinical trial approval and appreciate the importance of GCP
  • Gain an insight into the new CT Regulation and to prepare for future changes
  • Discover what goes into a drug dossier application to ensure speedy approvals
  • Examine the CTD with a detailed focus on the CMC/quality module, non-clinical study reports module and clinical study reports module
  • Appreciate the difference between pharmaceutical and biopharmaceutical products and compare the key regulatory differences
  • Understand the requirements of packaging and labelling pharmaceutical products in the EU
  • Learn how to file for variations in your product post approval for efficient life cycle management
  • Gain a solid grounding in pharmacovigilance and understand the importance of building a PV strategy to maintain patient safety

Training Course Content

  1. Overview of EU regulatory framework
  2. Product development: non-clinical studies
  3. Product development: clinical studies
  4. Marketing Authorisation 1/3: the regulatory procedures
  5. Marketing Authorisation Application 2/3: the registration dossier
  6. Marketing Authorisation Application 3/3: labelling and packaging requirements
  7. Post-MAA: filing variations and renewals
  8. Post-MAA: Pharmacovigilance obligations

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 2 reviews.
Reviews are published according to our review policy.
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Regulatory Publisher, Novo Nordisk
23 Jun 2020

The online sessions allowed me flexibility to fit training into my busy work schedule.

Senior RA Coordinator, Genmab A/S.
23 Jun 2020
Good overview

This course suited me perfectly in a busy time period. The possibility of completing each module around my schedule was very appealing. If you have little or no experience of th...

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