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Moving from Risk Management to Benefit-Risk Management – Embedding Pharmacovigilance Principles into the Product Life Cycle

Tutorial name:
Moving from Risk Management to Benefit-Risk Management – Embedding Pharmacovigilance Principles into the Product Life Cycle

Day & Time:
April 16, 2:00PM - 5:30PM (Central Europe Standard Time)

Room Number:
Helvetia 5 (Swissotel)

Registration Fees
- Standard Rate€450.00

Gunta Sveke,
Project Manager, Training Courses
DIA, Switzerland

Bill Richardson, MD
Medical Advisor
NDA Group, United Kingdom

Shelley Gandhi, MS
Strategic Advisor
NDA Group, United Kingdom


Pharmacovigilance, or the activity of monitoring the safety of medicines in clinical use and taking appropriate action to minimise risk, is governed by a range of new EU legislation, a new Pharmacovigilance Risk Assessment Committee (PRAC) and guidance. The value that can be gained from adopting a benefit-risk management system not only addresses known and potential risks to support the current regulatory status of products but also will feed into the further development of a product with regards to new indications and potentially moving from prescription only to over the counter.

This short course will discuss how access to robust evidence on emerging risk in post-authorisation phase, good data on how a medicine is used in clinical practice, and data on background rates in the exposed population; gathering evidence throughout the product life cycle will help move companies to a benefit-risk system. The ultimate challenge is working towards an integrated regulatory system, enabling users to query across all information within a company, designing safety studies, monitoring the effectiveness of the risk management systems and gathering robust evidence from clinical practice.

The lessons learned and our experiences so far with post-authorisation commitments (e.g. BRMPs, PASS, PSURs) will be reviewed as will whether these commitments really do support an acceptable benefit-risk profile. This will include the novel approaches to managing benefit-risk to meet the needs of licensing medicines in biotechnology such as advanced therapies. Communicating benefit-risk will also be discussed as the new legislation will push for greater patient involvement within a benefit-risk system. Better methodologies and tools are required to support this integrated approach and adoption of a quality management system across global enterprise could achieve this.


Learning Objective(s):
At the conclusion of this short course, attendees will be able to:
• Learn about effective strategies and the current thinking on risk mitigation in the context of benefit throughout the product life cycle.
• Understand how to access to robust evidence about emerging risk.
• Discover what the principles are for proportionate risk based assessment.
• Conquer those hurdles which get in the way to a systematic approach by reflecting on how these might be tackled

Target Audience:
Professionals in companies or regulatory authorities who are involved in pharmacovigilance operations and with responsibilities for post marketing clinical safety including those who are involved in:
• Pharmacovigilance
• Regulatory
• Clinical research
• Risk management
• Medical product safety assessment
• Data analysis
• Epidemiology
• Labelling
• Quality assurance and compliance
• Qualified Person for Pharmacovigilance (QPPV)