EU Regulatory Affairs Course Online

About the Course

Our EU regulatory affairs training course provides a grounding knowledge of regulatory frameworks in Europe. After over 5 weeks and 8 modules, you will gain a clear understanding of the EU regulatory structure and have a solid grasp of the submission process and the standards required by the regulators.

This EU regulatory affairs online 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, activities, and more.

Who Will Benefit

Our EU regulatory affairs course benefits 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 managers who would find knowledge of the regulatory environment useful

Key Learning Objectives

• Gain a complete overview of the EMA and the various types of MAAs
• Understand the regulatory affairs throughout 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

Course Information

Instructional Delivery Method: Scheduled Digital
Prerequisite & Advanced Preparation: Reading material will be sent prior to the course

Delivered by 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.

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