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 a 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.
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
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
The content of the PSMF (2):
Details of all of the sources of the relevant safety data
Safety Data Exchange Agreements
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
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
Putting all together: tools and aids
PSMF: only an EU requirement?
hands on exercise: make your own PSMF
Wrapping it up:
What to look for in a PSMF
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.
Basic knowledge of drug development and pharmacovigilance.
Presentations (with “deep dives” on particular subjects), hands-on exercises, group, and class discussions with a limited number of attendees.
Freelance Consultant and Senior Medical Advisor at PLG (Product Life Group)
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 has 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 ProductLife Group company, 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 25 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. 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, plus formal training in Data Science and Artificial Intelligence.
Principal Pharmacovigilance Writer at Boehringer Ingelheim
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.
MODULE 1 | 08 June 2022 from 9.30 am to 1.00 pm CEST
MODULE 2 | 10 June 2022 from 9.30 am to 1.00 pm CEST
MODULE 3 | 13 June 2022 from 9.30 am to 1.00 pm CEST
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:€ 1.100,00* (until 11 May 2022)
Freelance – Academy – Public Administration**:€ 715,00*
* 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.
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