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Fundamentals of EU Regulatory Affairs

4-week online academy | 2 hours per week

3 - 31 August 2020

Online Academy

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. Regulatory agencies 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 of regulatory affairs in Europe. Over 4 weeks and 8 modules you will gain a clear understanding of the EU regulatory structure 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.  

If you would like to start the course sooner than advertised simply get in contact with our training consultants by emailing [email protected] and we will arrange this for you as soon as possible.

  • 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

Sophie Nageotte

Sophie has over 20 years of experience in the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, Stragen, PregLem and Laboratoires Galderma. She gained a strong experience in the worldwide regulatory environment for the manufacture and control of the medicines.

She now runs her own consultancy, delivering consultancy and support in writing IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities.

Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.

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

PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Download the digital training guide.

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

Regulatory Publisher, Novo Nordisk


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 the regulatory world, I would recommend this course as it gives a good overview of the full regulatory dossier.

Senior RA Coordinator, Genmab A/S.


What the Online Academy Video

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