Spring conference in Munich, 13 May 2016

The pharmacovigilance special interest group (PV-SIG) hosted its inaugural seminar session at the Spring conference in Munich in 2016. The session asked the question: Are we ready for the patient’s voice through social media in the benefit-risk assessment of drugs? And the topic was introduced by Dr Alicia Ptaszynska-Neophytou (special projects officer from the UK’s MHRA) and by Dr Ulrich Vogel (Head of Strategic Data Analysis and Global Pharmacovigilance at Boehringer Ingelheim). Dr Ptaszynska-Neophytou explained the impact of social media and updated the audience on the MHRA’s WebRADR initiative, and Dr Vogel explained how patient support programmes can impact pharmacovigilance. Both presentations were followed by a lively discussion of these new and up-coming topics.


Spring conference in Birmingham, 03 May 2017

The pharmacovigilance (PV) expert seminar session (ESS) in Birmingham was titled ‘PV and Patients’ and discussed the challenges facing the pharmaceutical industry from the perspective of a global thought leader on writing for the lay audience, and the impact of new legislation from a regulatory authority perspective. The session continued to describe patient centricity and how this can be incorporated into clinical development and PV in particular. Prof. Theo Raynor (Professor of Pharmacy Practice at the University of Leeds) described ‘What patients really want and need from PV documents’ and this was supported by Dr. Juan García Burgos (Head for Medical and Health Information at the EMA), who discussed the RMP guidance update and the impact of the new EU Regulation No.536/2014. Following a tea break, Dr Pia Caduff-Janosa (Chief Medical Officer at the Uppsala Medical Centre) explained the difficulties of communicating emerging safety issues to a specialist and a non-specialist audience, and this was followed by Dr Emanuel Lohrmann’s (Lead Safety Physician, Global Pharmacovigilance Group, Boehringer Ingelheim) presentation on ‘How patients perceive and understand risk minimization measures’. The session concluded with an excellent Q&A session.

Spring conference in Barcelona, 02 May 2018

The pharmacovigilance (PV) expert seminar session (ESS) in Barcelona was a great opportunity to learn how to implement in practice the revised guidance on risk management plans from true experts: Val Simmons (EU QPPV at Eli Lilly and member of the EFPIA PV Committee) and Sven Schirp (Head of global PV writing at Boehringer Ingelheim). The speakers were also available at the PV lunch roundtable for further, informal discussions.The session report is available here.