Fundamentals of EU Regulatory Affairs

• 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