10.00 - 13:00 Workshop A: Ensuring companywide readiness for pharmacovigilance inspections

This interactive workshop will guide you through the procedure of preparing for a regulatory inspection and will provide an opportunity to review your current procedures and identify ways to improve your approach to ensure that you are inspection ready at all times. Delegates will explore issues including:

• Preparing for risk based inspections to meet the regulators’ expectations
• Compiling an inspection readiness plan to ease the regulatory burden
• Improving interaction between the PV team and regulators

Led by:

Dr. Monica Rusu
Director Pharmacovigilance EELA
Abbott Products GmbH

14.00 - 17:00 Workshop B: Writing A Successful Risk Management Plan

This is a practical workshop designed to provide delegates with guidance on developing robust risk management plans that meet regulatory guidelines. The workshop will help you to identify key factors in risk management and incorporating them effectively into your RMP. Delegates will cover:

• The essentials of risk management and minimisation
• Knowing what the regulators want and ensuring RMPs meet expected requirements
• Practical exercise in developing your risk management plan

Led by: