Introduzione
This course introduces the Risk Management Plan (RMP) and the related requirements, structure, content, and activities. Terms such as "safety concern" and "important risk" will be explained according to the GVP V Rev. 2 guidance and compared to definitions and use in other pharmacovigilance documents. In addition, the life cycle of RMPs and the interrelation between the RMP and the Periodic Safety Update Report (PSUR) will be addressed.
Pharmacovigilance Documents – Focus on the Risk Management Plan (RMP)
“The life beyond submission: Risks and Plans”
- Focus on the RMP (Risk Management Plan)
- Who, when, what and how.
- Life cycle of the safety concerns in RMPs: not all risks are created equal
- Review of the list of safety concerns according to the GVP V Rev.2 module
- Examples from renewal assessment reports
- Review of safety concerns: RMP and PSUR, align or not align?
- Safety concerns in RMP and PSUR: from theory to practice
- Breakout sessions and interactive discussion of the results
- Assessment and review of key concepts
Professionals involved in the planning, preparation, coordination and review of aggregated 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:
For the participation in these training courses is required:
- Previous attendance to the “Pharmacovigilance Documents – Basic Concepts and Definitions for Pharmacovigilance Writing” training
- In alternative, a basic knowledge of PV writing
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 in 1 module
26 September 2023 – h.09:00 am / 01:00 pm CEST
The training 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.
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This course is part of the training path “Pharmacovigilance Documents in the Life Cycle of a Medicinal Product”. Click here for the path details.
Early Bird: € 495,00* (until 05 September 2023)
Ordinary: € 625,00*
Freelance – Academy – Public Administration**: € 375,00*
* 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.
