Introduzione
The EU Directive 2010/84/EU (amending 2001/83/EC) requires each application for Marketing Authorisation (MA) for the EU to have a Pharmacovigilance System Master File (PSMF) in place including the named Qualified Person responsible for Pharmacovigilance within the EEA.
Any company that has at least one pharmaceutical product approved in the European Union is therefore required to have a PSMF in place.
The PSMF gives regulators a complete description and assessment of the full pharmacovigilance system, and the annexes' outputs help them determine how well a company is complying.
To ensure compliance, this training will provide practical guidance to developing, drafting, maintaining, and updating the PSMF.
The sessions will also discuss the PSMF's importance in regulatory inspections, as well as common PSMF inspection findings.
Module 1
- Introduction
- Why the PSMF?
- The regulatory framework (GVPs Modules II and I)
- The PSMF (and its Annexes) as a dynamic document
- The PSMF as the “core” of the Pharmacovigilance System
- The PSMF as the “key reference document” for all PV related operations
- The role of the QPPV
- The PSMF for SOP preparation/maintenance and training
- poll/exercise
- The content of the PSMF (1):
- Details of the qualified person responsible for pharmacovigilance (QPPV)
- Details of the organization structure of the company that actually holds the Marketing Authorisation or applies for the Marketing Authorisation
- poll/exercise
- The content of the PSMF (2):
- Details of all of the sources of the relevant safety data
- Safety Data Exchange Agreements (SDEA)
- Details of all electronic (computerized) systems and databases
- Details of all pharmacovigilance processes
- Details of the performance of all drug safety systems
- Details of all quality control systems
- Details of all of the sources of the relevant safety data
Module 2
- From theory to reality:
- Inspection/audit findings on PSMF
- Good PSMFs, bad PSMFs and “so and so” PSMFs
- PSMF and SOPs
- hands on exercise: evaluate sample PSMFs
- Your company’s PSMF:
- The PSMF as an exercise in (good) project management
- The professionals involved (within and outside the organization)
- Safety Data Exchange Agreements (SDEA)
- Putting all together: tools and aids
- Maintenance
- PSMF: only an EU requirement? Considerations and discussion on non-EU PSMF
- hands on exercise: make your own PSMF
- Wrapping it up:
- What to look for in a PSMF
- Audit/inspection readiness
- After the audit/inspection
- Advice/suggestions on form and content of the PSMF
- final poll and discussion
Professionals involved in the planning, preparation, review, and maintenance of PSMFs.
In particular: Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. pharmacovigilance officers, pharmacovigilance managers, QPPVs, document quality and compliance managers, any functions involved in delivering materials for the PSMF, as well as document managers who are involved in the technical finalization of the document.
Participant’s experience
Basic knowledge of drug development and pharmacovigilance.
Presentations, 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 – 2 modules
MODULE 1 | 13 June 2025 from 9:00 am to 1:30 pm CEST
MODULE 2 | 20 June 2025 from 9:00 am to 1:30 pm CEST
The course admits maximum 12 attendees.
After the registration, you will receive all details about the connection.
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: € 995,00* (until 23 May 2025)
Ordinary: € 1.230,00*
Freelance – Individual – Academy – Public Administration**: € 745,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – 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.
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.
