Attestato di partecipazione
Introduzione
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 PSURs and other pharmacovigilance documents in the life cycle and how to address selected challenges of document preparation.
MODULE 1: A never ending story (life cycle management in pharmacovigilance)
- Introduction of participants
- Objectives of the modules
- Fine-tuning according to the participants’ needs (“deep dive” topics)
- The life cycle of a medicinal product from the pharmacovigilance perspective
- Benefit-risk analysis
- Breakout sessions and interactive discussion of the results
- “Deep dive”: see list of topics below
- Assessment and review of key concepts
MODULE 2: The main actors
- Basic concepts and definitions for pharmacovigilance writing
- Breakout sessions and interactive discussion of the results
- Interaction of the main pharmacovigilance documents through the life cycle of medicinal products:
– 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) - Focus on DSURs
- Breakout sessions and interactive discussion of the results
- Focus on RMPs
- Breakout sessions and interactive discussion of the results
- “Deep dive”: see list of topics below
- Assessment and review of key concepts
MODULE 3: The life beyond submission
- Life cycle of the safety concerns in RMPs: not all risks are created equal
- Breakout sessions and interactive discussion of the results
- Assessment reports on RMPs and impact on PSURs
- Focus on PSURs: requirements, structure and contents
- Breakout sessions and interactive discussion of the results
- “Deep dive”: see list of topics below
- Assessment and review of key concepts
MODULE 4: Focus on PSUR
- PSUR writing: challenges and pitfalls
- Document assessment
- Preparation for the role playing: plan, plan, plan
- Role play: design your own PSUR
- “Deep dive”: see list of topics below
- Assessment and review of key concepts
“Deep dives” topics: additional topics that could be addressed in detail according to the attendees’ interest:
- Be your own documentalist and statistician:
– Signal management and data collection
– Evaluation of sources and data - Causality judgment: experience vs automation
- Safety concerns in RMP and PSUR: from theory to practice
– Review of the list of safety concerns according to the GVP V Rev.2 module
– Examples from renewal assessment reports
– Review of safety concerns: alignment of RMP and PSUR - RMP and PSUR: global planning and management
- Experience from PSUR authority assessment reports: what really matters
- Referrals: the worst pharmacovigilance challenge
- Social network in Pharmacovigilance: a bubble that has burst
- New technologies in pharmacovigilance (artificial intelligence etc.)
Professionals involved in the planning, preparation and review of consolidated Safety reports.
In particular: 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 and medical evaluators/advisors, document quality and compliance managers).
Participant experience
Basic knowledge of drug development and pharmacovigilance.
Presentation, hands-on exercises, group, and class discussions with a limited number of attendees.
Docente/i
Marco Anelli
Marco 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, plus formal training in Data Science and Artificial Intelligence.
In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment.
Marco has been a free-lance consultant in Medical Affairs and Pharmacovigilance/ Drug Safety since 2022.
Before that, he has been “Head of Pharmacovigilance and Medical Affairs Advisory Services” at ProductLife Group (PLG).
As “Deputy Chief Scientific Officer”, always at PLG, Marco has also coordinated 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 consultancy company (later acquired by PLG), where was responsible for the oversight 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 more than 30 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities.
Marco has participated in and supervised 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.
Tiziana von Bruchhausen
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 principal 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.
Online Training – 4 modules
MODULE 1 | 16 November 2021 from 09:30 am to 1:00 pm CET
MODULE 2 | 18 November 2021 from 09:30 am to 1:00 pm CET
MODULE 3 | 23 November 2021 from 09:30 am to 1:00 pm CET
MODULE 4 | 25 November 2021 from 09:30 am to 1:00 pm CET
After the registration, you will receive all details about the connection.
The course admits maximum 12 attendees.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 1.420,00* (until 31 October 2021)
Ordinary: € 1.620,00*
Freelance – Academy – Public Administration**: € 920,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Registrati
Versione Stampabile
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.