Assessing and controlling risk is essential throughout the product life cycle of a drug, from research and clinical testing to manufacturing and distribution. Organisations must demonstrate to the competent authority that a documented plan is in place to identify, measure, control and monitor the various risks that exist.
Through case studies and examples you will gain a detailed view of risk from a regulatory perspective by examining simple risk assessment techniques and mitigation methods for specific risks including product recalls. Once completed you will better understand 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:
We're looking forward to welcoming our attendees and expert course leaders at Regulatory Affairs Risk Management in London in June.
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