28th Annual EuroMeeting

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Communicating Benefit-Risk Information in Risk Management Plans to Medical Professionals and the General Public

Session Chair(s)

Tiziana Von Bruchhausen, PhD

Senior Global Pharmacovigilance Writer

Boehringer Ingelheim Pharma, Germany

The new pharmacovigilance legislation has brought into focus benefit/risk management and communication in a medicines’ life cycle. The risk management plan (RMP) has become a complex living document that encompasses the pre- and post-authorisation phases and requires a multidisciplinary approach and alignment with other submission documents. In line with the new requirements on transparency, the RMP template mandates to provide a summary of safety and efficacy information for two antipodal audiences - medical professionals and the general public. This session will explore the challenges of communicating benefit/risk information and will discuss some experiences from the industry and the EMA perspective.

Speaker(s)

The Role of Regulators in Providing Information on Medicines to Patients and Healthcare Professionals

Juan Garcia-Burgos, MD, PhD

European Medicines Agency, Netherlands

Head of Public and Stakeholders Engagement Department

Benefit-Risk Communication in the Life Cycle and How It Is Reflected RMPs

Shelley Gandhi, MSc

Independent, United Kingdom

PV trainer

The Role of a Medical Writer in Effective Benefit/Risk Communication

Budhesh Dhamija, MPharm

ITM Oncologics GmbH, Germany

Senior Director, Head of Clinical Regulatory Affairs

Writing the Lay Summary (Section VI) of Risk Management Plans – Why and How?

Lisa Chamberlain-James, PhD

Trilogy Writing & Consulting, United Kingdom

Senior Partner

Panel Discussion

Peter Richard Arlett, MD, FFPM, FRCP