This course will provide you with a detailed view of risk from a regulatory perspective. This 2 day course is packed with case studies, providing you with practical insight from simple risk assessment techniques, to how to mitigate specific risks including product recalls.
You will also view risk from the authorities point of view, enabling you to be better prepared for questions from global regulators. It will allow you to create robust risk management reports with advanced strategies for a variety of products.
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.
This course has been specifically designed to address the needs of: