A Beginners Guide to EU Regulatory Affairs - Online Academy

Salma Michor, PhD, RAC is the founder of Michor Consulting providing services to the pharmaceutical and medical device sectors, specializing in regulatory affairs, regulatory compliance, quality assurance, risk management and interim management. Michor Consulting is an established and licensed entity, and can act as your European Authorised Representative for CE marked medical devices. Dr.Michor serves as an independent expert for the European Commission since 2004, evaluating and reviewing industrial research projects for Small and Medium sized Enterprises(SMEs) and the Marie Curie Fellowships programme for the 6th and 7th Framework programmes.

• 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

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