2025-07-31 2025-07-31 , online online, 1,290 € plus tax Dr. Petra Lerner-Hiller https://www.forum-institut.com/seminar/25092051-the-pharmacovigilance-system-master-file-psmf-in-a-global-environment/referenten/25/25_09/25092051-course-pharmacovigilance-system-master-file-psmf_lerner-hiller-petra.jpg The Pharmacovigilance System Master File (PSMF) in a Global Environment

This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!

Topics
  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes: Practical hints and common pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight and duties of local PV officers


Who should attend
This course will be conducted in English.

This online seminar is valuable for anyone in the global pharmaceutical industry involved in the preparation and maintenance of the PSMF. It is aimed at both global and local PV functions.

Familiarity with the European PV framework is recommended for participants.
Aims and objectives
The PSMF is widely recognised and used worldwide. However, specific local requirements must be considered separately. In Europe, for example, some countries, such as France, mandate additional documents. Managing a core PSMF alongside local annexes is therefore becoming increasingly important and complex.

This seminar will provide you with the skills to develop, maintain, and optimise a global PSMF while integrating local requirements. You will gain valuable insights into regional regulations in the UK, France, the EAEU (Eurasian Union), and Arab countries. Benefit from the expertise of our Big Pharma professionals.
Your benefit

This online-seminar will make you knowledgeable about

  • the regulatory requirements and the responsibilities for the content and maintenance of a global PSMF .
  • how to structure a core PSMF.
  • the local peculiarities that must be addressed in the PSMF and what the local annexes should contain.
  • how to effectively manage the PSMF lifecycle on a global scale.

Online course - The Pharmacovigilance System Master File (PSMF) in a Global Environment

The Pharmacovigilance System Master File (PSMF) in a Global Environment

Core PSMF vs local annexes

Benefits
  • Create a stable core PSMF
  • Practical, first-hand expertise
  • Includes workshop "Global PSMF"
  • Certified to ISO 9001 and ISO 21001 standards

Webcode 25092051

Book now

JETZT Buchen
Speakers

Dr. Petra Lerner-Hiller

Senior PV Auditor, PV Quality Consultant, Deputy QPPV, and QPPV Relations Lead, Darmstadt, GERMANY

Dr Petra Lerner-Hiller has more than 20 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs word-wide.

Ivana Vukic, MPharm

Senior Pharmacovigilance & Quality Expert, Munich, GERMANY

Senior Pharmacovigilance & Quality Expert

Everything at a glance

Appointment

18/09/2025

18/09/2025

Period

09:00-17:00 CEST
You may dial in 30 min before the course starts

09:00-17:00 CEST
You may dial in 30 min before the course starts
Venue

online

online

Downloads
List of Abbreviations Pharmacovigilance BROCHURE
List of Abbreviations Pharmacovigilance BROCHURE
Fee

Event - 1,290 € plus tax
The fee includes high-quality course material and a certificate for download, access to the Learning Space as well as technical support including a test meeting.

Event - 1,290 € plus tax
The fee includes high-quality course material and a certificate for download, access to the Learning Space as well as technical support including a test meeting.

Inhouse-offers
Request inhouse-offer
Request inhouse-offer

Book now

Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!

Topics

  • Concept of a global PSMF
  • Structure and content of a core PSMF
  • Local annexes: Practical hints and common pitfalls
  • Effective maintenance: Impact assessment, ad-hoc updates and change control
  • QPPV oversight and duties of local PV officers


Who should attend
This course will be conducted in English.

This online seminar is valuable for anyone in the global pharmaceutical industry involved in the preparation and maintenance of the PSMF. It is aimed at both global and local PV functions.

Familiarity with the European PV framework is recommended for participants.

Aims and objectives

The PSMF is widely recognised and used worldwide. However, specific local requirements must be considered separately. In Europe, for example, some countries, such as France, mandate additional documents. Managing a core PSMF alongside local annexes is therefore becoming increasingly important and complex.

This seminar will provide you with the skills to develop, maintain, and optimise a global PSMF while integrating local requirements. You will gain valuable insights into regional regulations in the UK, France, the EAEU (Eurasian Union), and Arab countries. Benefit from the expertise of our Big Pharma professionals.

Your benefit

This online-seminar will make you knowledgeable about

  • the regulatory requirements and the responsibilities for the content and maintenance of a global PSMF .
  • how to structure a core PSMF.
  • the local peculiarities that must be addressed in the PSMF and what the local annexes should contain.
  • how to effectively manage the PSMF lifecycle on a global scale.

Detailed programme

09:00-17:00 CEST
You may dial in 30 min before the course starts

08:45 - 09:00

Technical warm-up
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.

09:00

FORUM Institut

Welcome and Introduction

09:15

Dr Petra Lerner-Hiller

Concept of a global PSMF
  • GVP Module II requirements for the PSMF
  • Seven-day requirements
  • Expectations of competent authorities and PSMF inspection findings

10:30 - 10:45 Coffee break


10:45

Ivana Vukic, MPharm

Core PSMF vs local annexes
  • Structure and content of a core PSMF
  • Local requirements for France, the EAEU (Eurasian Union), the Middle East and the UK
  • Global vs local requirements (overlap and discrepancies)
  • Creation of the PSMF
  • Practical tips and pitfalls

12:30 - 13:30 Lunch break


13:30

Dr Petra Lerner-Hiller

QPPV oversight
  • Which QPPVs and local PV officers need to be involved?
  • Who is responsible overall?
  • Update planning and coordination and collaboration of contributors

14:45 - 15:00 Coffee break


15:00

Ivana Vukic, MPharm

Effective maintenance of a global PSMF
  • Body text vs annexes
  • Impact assessment and quality control
  • Management of ad hoc updates
  • Change control, logbook, versions and archiving

16:00

Both speakers

Workshop: Global PSMF - Dos and don'ts

17:00 End of course


Seminar Extras

Competence Check

Are you ready to challenge your pharmacovigilance knowledge? Our interactive quiz offers an engaging and enjoyable way to assess your expertise.
Simply click on the answers you think are correct!

Further Information

Tailored Training for Your Company: In-House Seminars

  • Online, on-site, and hybrid formats
  • Available in German and English
  • Customised programmes

    Would you like to cost-efficiently train multiple employees in your company on a pharmacovigilance topic? This seminar is an example of our proven in-house training programmes. Whether you need an existing seminar concept, a specialised topic, or a tailored training for your organisation, we are here to support you!

    I would be delighted to plan your in-house training with you. Please feel free to contact me by phone or email. I look forward to your enquiry!

    Nadja Wolff
    Conference Manager Pharma/Healthcare
    n.wolff@forum-institut.de
    Phone: +49 6221 500-696

    • Benefits of a FORUM Institut training course

    FORUM Institut’s all-in-one training platform uses the latest teaching methods.
    All our online training courses take place in the Learning Space, our holistic learning environment with many features that promote effective and sustainable learning.

    • Live and interactive learning on our Learning Space training platform
    • A platform with many features: events rooms, chat, course agendas and documents, surveys, workshop rooms and much more
    • Easy surveys with Slido
    • ‘Deluxe’ chat: group chats, one-to-one chats, one-to-one video chats
    • A central repository for documents and media
    • Other services and apps such as Padlet and Mentimeter available directly on the platform
    • The perfect marriage of teaching methods and technology
    • High level of interactivity with plenty of opportunity for questions
    • Continuous support throughout the event to ensure the most effective learning
    • Free technical pre-meeting to start off your training on the right foot

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    All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

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    Learn more about our online events here.

    Free pre-meeting and technology check

    You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

    The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

    This distinguishes our events

    Overall impression: 100% of participants rated with 5 stars out of 5 stars (February 2024)

    Practical benefit:100% of participants rated with 4 or 5 stars out of 5 stars (February 2024)

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    Testimonials

    It was very helpful and extensive, in particular with respect to local vs. global requirements. I liked the fact that the local PSMF requirements in different non-EU countries were presented seperately and in detail.

    Well-structured course that provides insights and tips for good management of the PSMF according to all international and local regulations.

    Informative, interactive, great group with lot of interessting questions.

    Great preparation of the speakers and their ability to involve all the paticipants!