This course gives an overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product. After an introduction on benefit-risk analysis, signal management, and data collection process, the presentations will focus on regulatory, format and content requirements of the main pharmacovigilance documents.
While the course is based on the EU requirements, a few relevant insights about the most relevant local requirements will be provided. The participants will learn how to plan and manage documents in the life cycle and how to address selected challenges of document preparation.
Who is this course for?
This course targets participants coming from Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs e medical evaluators/advisors, document quality and compliance managers).
Basic knowledge of drug development and pharmacovigilance
• The life cycle of a medicinal product from the pharmacovigilance perspective
• Benefit-risk analysis
• Signal management and data collection
• Development Safety Update Report (DSUR)
• Periodic Safety Update Report (PSUR)/ Periodic Benefit-Risk Evaluation Report (PBRER)
• Risk Management Plan (RMP)
• Addendum to Clinical Overview (AddCO)
• Document assessment
• Planning, gap analysis and preparation of PV documents.
Course Language: English
Presentation, hands-on exercises, group and class discussions
At the end of the training, you will be able to:
- Understand the main pharmacovigilance activities in the life cycle of the medicinal product
- Plan and prepare DSURs, PSURs/PBRERs, RMPs, and AddCOs, exploting similarities and synergies among the different documents
- Apply writing skills to the preparation of pharmacovigilance documents
Head of Medical Affairs and Pharmacovigilance Advisory Practice – PLG (Product Life Group)
Marco Anelli has been appointed in January 2016 “Head of Pharmacovigilance and Medical Affairs Advisory Services” at PLG. Previously, Marco has been R&D Director at Keypharma, an Italy-based ProductLife Group company, and was responsible for the coordination of all clinical and preclinical aspects of projects run internally and on behalf of clients. Drawing on a career in the pharmaceutical industry that spans 25 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities. Marco has participated in and coordinated all stages of drug development – from formulation to Phase I-IV and pharmacovigilance. In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries. Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand. In recent years, has worked extensively in the fields of pharmacoeconomics and health technology assessment. He has a medical degree from Milan University, specializations in Medical Statistics and Clinical Pharmacology from Pavia University and an international master’s degree in health economics and pharmacoeconomics from Pompeu Fabra University in Barcelona. As “Deputy Chief Scientific Officer” of PLG, Marco is coordinating all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning.
Tiziana von Bruchhausen
Senior Global Pharmacovigilance Writer – Boehringer Ingelheim
Vice President of the European Medical Writers Association
Dr von Bruchhausen is a senior pharmacovigilance writer with profound knowledge and hands-on experience in various areas of pharmacovigilance ranging from case processing to preparation of regulatory documents, global submissions, and interactions with health authorities. She gained her background in pharmacovigilance while working at a contract research organisation, where she headed teams with tasks of literature safety review, case processing, and pharmacovigilance writing. Before holding her current position, she worked as a freelance pharmacovigilance writer for international middle-sized and big pharmaceutical companies.
Dr von Bruchhausen is a highly engaged member of the European Medical Writers Association (EMWA), regularly presents workshops at EMWA conferences, leads the EMWA pharmacovigilance special interest group, and currently represents the association as vice president 2017 / president 2018.