Course description
Regulatory Affairs Risk Management
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.
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Suitability - Who should attend?
This course has been specifically designed to address the needs of:
- Regulatory Affairs Managers/ Officers/ Assistants
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Qualified Persons
- Senior level managers who need an overview
Training Course Content
What will you learn?
- Introduction on Pharmaceutical Risk Management
- Identifying and understanding the areas of Pharmaceutical Risk Management
- Road map to Risk Management Report
- Company Preparation of Risk Assessment & Regulator Communication and Control
- Case study: Risk Assessment, Control and communication
- The function and Objective of the Quality Risk Assessment to authorities
- Post Marketing Product Risk Management
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5