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2-day course

Gain a practical insight into everything from simple risk assessment techniques to risk mitigation at an advanced level

Course Overview

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 authority's 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.

What will you learn?

Quality Risk Assessment reports

Learn how to build a robust Quality Risk Assessment report

Risk management

Identify and understand the areas of Pharmaceutical Risk Management to manage risks more effectively

Communication with authorities

Learn how to effectively deal with authorities


Learn how to mitigate risks

Post market product risk management

Understand the post-market procedures you will need to undertake

Who is this course for?

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

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.