Overview

Are you aware of the key developments on the benefit-risk guidelines?

Benefit-risk guidelines continue to evolve with the EMA publishing guidance revisions as recently as this March. This workshop provides you the tools to address these changes by giving you:

Overview of benefit-risk assessments
Examples of challenges and solutions across different departments
Impacts and interpretations of the new guidelines

EMA experts join this workshop to give you tangible insights and tips to navigate the evolving benefit-risk guidelines. The hands-on workshop structure provides you with real-world examples from regulatory and industry perspectives, and explores tangible ways to improve your best practices.

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Exhibits

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Exhibits

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Who should attend?

Professionals involved in benefit-risk strategy from various departments, e.g. pharmacovigilance, regulatory, clinical, drug safety, medical affairs, or medical writing.

Program leads who oversee the clinical development, dossier preparation, and post-marketing phases of the medicines life cycle.

Learning objectives

What will you gain?

New benefit-risk regulations call for a more structured and formalised process. This workshop will:

Increase your understanding of the current benefit and risk landscape
Empower you to perform benefit-risk management more effectively within your organisation
Create a toolkit for you to address tactical components of risk assessments, including data collection and digital innovation

Program Committee

Martin Huber, MPH, MPharm Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
Federal Institute for Drugs and Medical Devices (BfArM), Germany
Steve Mayall, PhD Director
Huron Consulting Group, United Kingdom
Jan Petracek, MD, MSc CEO
Ivigee, Czech Republic
Steffen Thirstrup, MD, PhD Chief Medical Officer
European Medicines Agency, Netherlands