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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:

  1. Overview of benefit-risk assessments
  2. Examples of challenges and solutions across different departments
  3. 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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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
    Martin Huber PRAC Member
    Federal Institute for Drugs and Medical Devices (BfArM), Germany
  • Steve  Mayall, PhD
    Steve Mayall, PhD Principal Consultant
    Pope Woodhead & Associates Ltd, United Kingdom
  • Jan  Petracek
    Jan Petracek CEO
    PrimeVigilance and PharmInvent, Czech Republic
  • Steffen  Thirstrup, MD, PhD
    Steffen Thirstrup, MD, PhD Director
    NDA Advisory Services Ltd, United Kingdom
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