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Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities
Development Safety Update Report (DSUR), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER), and Addendum to the Clinical Overview
This course gives an overview of the pharmacovigilance activities and the related documents throughout the life cycle of a medicinal product. We will address:
- benefit-risk analysis
- signal management
- data collection process
- regulatory, format and content requirements.
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.
- 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.
Marco Anelli has been appointed in January 2016 “Head of Pharmacovigilance and Medical Affairs Advisory Services” at PLG. As “Deputy Chief Scientific Officer” of PLG, Marco coordinates all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning.
Previously, Marco was R&D Director at Keypharma, an Italy-based ProductLife Group company, where 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 the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment.
He has a medical degree from the University of Milan, specializations in Medical Statistics and Clinical Pharmacology from the University of Pavia and an international master’s degree in health economics and pharmacoeconomics from the University of Pompeu Fabra in Barcelona.
Tiziana von Bruchhausen, PhD specialises in pharmacovigilance writing and has gained over 10 years’ experience while working in various roles for mid-sized and large pharmaceutical companies. She is currently employed as a senior pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on DSURs, RMPs, PSURs, and health authorities’ assessment reports.
Tiziana actively promotes the professional role of medical writers in pharmacovigilance through workshops and lectures Europe-wide and has served as a session chair at international conferences. She is an active volunteer at the European Medical Writers Association (EMWA), where she has been chairing since 2017 the Pharmacovigilance Special Interest Group Committee. She was Vice President of EMWA in 2017-2018 and President in 2018-2019.
Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmaco¬vigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.
Limited number of participants to encourage networking and discussion.
All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.
All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.
Early Bird: € 1.535,00* (until 16 June 2020)
Ordinary: € 1.755,00*
Freelance - Academy - Public Administration**: € 810,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Tuesday, June 16, 2020
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 DSUR, PSUR/PBRER, RMP, and AddCO, exploiting similarities and synergies among the different documents
Apply writing skills to the preparation of pharmacovigilance documents