DIA Workshop on Benefit-Risk Strategy


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.

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