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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)
Juan Garcia-Burgos, MD, PhD
Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
The Role of Regulators in Providing Information on Medicines to Patients and Healthcare Professionals
Shelley Gandhi, MS
Partner & PV trainer, Eliquent Life Sciences, United Kingdom
Benefit-Risk Communication in the Life Cycle and How It Is Reflected RMPs
Budhesh Dhamija, MPharm
Senior Director, Head of Clinical Regulatory Affairs, ITM Oncologics GmbH, Germany
The Role of a Medical Writer in Effective Benefit/Risk Communication
Lisa Chamberlain-James, PhD
Senior Partner, Trilogy Writing & Consulting, United States
Writing the Lay Summary (Section VI) of Risk Management Plans – Why and How?
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Panel Discussion
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