Spring conference in Prague, 2023
- “ Safety Communication: Why it matters to patients and healthcare providers.” This Expert Seminar was developed jointly by the EMWA’s CwP and PV SIG to explore the complex topic of benefit-vs-harm and safety communication for patients, and the role of medical writers to better enable informed decision-making. Different perspectives on the topic have been represented by the speakers (Dr. Lawrence Liberti, former Managing Director of CIRS; Dr. Julia Anna Gindele, Boehringer Ingelheim; Dr. Marilyn Neault, Research Patient Advocate, Parkinson’s Foundation) and panelists.
- Seminar on “ Introduction to benefit-risk assessment for medical writers” (Larry Liberti, former Managing Director of CIRS) . Objective of this seminar: to provide participants with a good understanding of the importance of this concept (e.g. for regulatory submissions to the FDA and EMA, particularly in the context of the Clinical Summaries of Safety and Efficacy, and the Integrated Summaries of Safety and Efficacy) and show which role the medical writer plays in constructing the elements of the benefit-risk sections of regulatory dossiers.
Spring conference in Berlin, 2022
The PV SIG organized a sub-session within the Regulatory Expert Seminar with the title “Accelerated authorisation procedures in the EU: the example of Covid-19 vaccines”. After an introduction on how risks and benefits are defined and assessed for vaccines (Andrew Finlayson, BioNTech), regulatory aspects, opportunities, and experience related to accelerated authorisaton procedures for the Covid-19 vaccines were addressed (Morgane De Verdière; European Medicines Agency; Ruben Rizzi, BioNTech). A medical writing perspective on the preparation of Risk Management Plans for Covid-19 vaccines was given as well (Becky Bartlett, Effective Medical).
Virtual ESS, 07 October 2020
‘Life cycle safety and risk management for medical devices – an integrated approach’ - This Expert Seminar, which was developed jointly by the EMWA’s PV SIG and Medical Devices SIG, took place as a virtual event. After a brief overview on pharmacovigilance writing in the life cycle of a medicinal product from its development to post-marketing surveillance (Dr. Tiziana von Bruchhausen, Boehringer Ingelheim), Dr. Birgit Jorg (Edwards Lifesciences) provided an overview on medical writing activities and clinical safety documents involved in pre- and post-market studies, pointing out key aspects of safety writing for medical devices. Markus Pöttker (Smith & Nephew) discussed how to implement pro-active elements of post-market surveillance according to the new European Medical Device Regulation (EU MDR) 2017/745, and the new standardised terminology corresponding to relevant IMDRF (International Medical Device Regulators Forum) codes. The last speaker, Dr. Jos van Vroonhoven (Philips), presented requirements and processes related to risk management for medical devices according to the new edition of ISO 14971 and guidance in ISO/TR 24971:2020. He provided a detailed overview of responsibilities, aims, and activities involved in the risk management process. Besides very informative presentations, there were excellent Q&A and panel discussions and a lively interaction with the auditorium.
Spring conference in Vienna, 08 May 2019
The PV SIG ESS session at the May conference, entitled ‘RMPs and new format PSURs (PBRERs): what the regulators really want and how to give it to them’ was a great success! It was really well attended, and the feedback from EMWA members was overwhelmingly positive. The session discussed the problems faced by Industry when producing Periodic Benefit Risk Evaluation Reports (PBRERs) and Risk Management Plans (RMPs) in the light of the new legislation from Dr Jean Kilgour-Christie (Novartis), and also gave unique insights from the Regulators’ perspectives, gained from reviewing these documents submitted from companies across the Pharmaceutical Industry. Dr. Stephanie Millican (Unit Manager) and Dr Janet Nooney (Expert Assessor) from the MHRA told EMWA members about the most common mistakes seen from the assessors’ points of view, and the audience made the most of the opportunity to ask questions of the panel in a discussion session that had to be stopped because we ran out of time!
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.
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 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.