2025-06-06 2025-06-06 , online online, 2,090 € zzgl. MwSt. Dr. Martin Huber https://www.forum-institut.de/seminar/25102053-an-introduction-for-pharmacovigilance-managers/referenten/25/25_10/25102053-course-an-introduction-for-pharmacovigilance-managers_huber-martin.jpg An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!

Topics
  • Regulatory framework and EMA GVP modules
  • Management of side effects and signals
  • Benefit-risk assessment and risk management
  • Important pharmacovigilance documents
  • Interfaces with other departments and quality management


Who should attend
This course will be conducted in English.

This online course is designed for beginners in drug safety with up to one year of pharmacovigilance experience. It is ideal for former students of medicine or natural sciences, and professionals transitioning from the pharmaceutical industry. In particular, it is suited for staff in the following departments:
  • drug safety, patient safety, pharmacovigilance,
  • quality management, clinical research, medical affairs, and regulatory affairs.
Aims and objectives
This online course provides comprehensive knowledge on all the essentials of pharmacovigilance over two days. It equips participants with the necessary tools to confidently fulfil their responsibilities in the various aspects of pharmacovigilance.

The course will enable you to:
  • Describe the mechanisms of pharmacovigilance in Europe.
  • Classify information on adverse drug reactions including MedDRA coding.
  • Properly assess the responsibilities of pharmacovigilance officers.
  • Understand the significance of pharmacovigilance and risk management systems.
  • Comply with risk assessment procedures.
Your benefit

This foundational course offers a comprehensive overview of pharmacovigilance, providing you with essential knowledge from both a regulator's and industry perspective.

In addition, the training contains many interactive parts to break up the training and deepen the learning. The quiz and the workshops "Individual causality assessment" and "Risk minimisation measures and risk communication" reinforce the theoretical content and teach you how to put knowledge into practice. The final workshop, "Drug safety in the life cycle of a drug", gives you the opportunity to consolidate what you have learned.

This course will helps you to better navigate the diverse responsibilities within drug safety and leads to a qualified certificate.

Online course - An Introduction for Pharmacovigilance Managers

An Introduction for Pharmacovigilance Managers

Start your career in Drug Safety

Benefits
  • Condensed overview of pharmacovigilance
  • Delivered by two PV experts with different professional backgrounds
  • Interactive format
  • Officially certified to the ISO 9001 and ISO 21001 standards

Webcode 25102053

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

20-21/10/2025

20-21/10/2025

Zeitraum

Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts

Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts
Veranstaltungsort

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

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

Details

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Take the next step in your professional growth - enrol now!

Topics

  • Regulatory framework and EMA GVP modules
  • Management of side effects and signals
  • Benefit-risk assessment and risk management
  • Important pharmacovigilance documents
  • Interfaces with other departments and quality management


Who should attend
This course will be conducted in English.

This online course is designed for beginners in drug safety with up to one year of pharmacovigilance experience. It is ideal for former students of medicine or natural sciences, and professionals transitioning from the pharmaceutical industry. In particular, it is suited for staff in the following departments:
  • drug safety, patient safety, pharmacovigilance,
  • quality management, clinical research, medical affairs, and regulatory affairs.

Aims and objectives

This online course provides comprehensive knowledge on all the essentials of pharmacovigilance over two days. It equips participants with the necessary tools to confidently fulfil their responsibilities in the various aspects of pharmacovigilance.

The course will enable you to:

  • Describe the mechanisms of pharmacovigilance in Europe.
  • Classify information on adverse drug reactions including MedDRA coding.
  • Properly assess the responsibilities of pharmacovigilance officers.
  • Understand the significance of pharmacovigilance and risk management systems.
  • Comply with risk assessment procedures.

Your benefit

This foundational course offers a comprehensive overview of pharmacovigilance, providing you with essential knowledge from both a regulator's and industry perspective.

In addition, the training contains many interactive parts to break up the training and deepen the learning. The quiz and the workshops "Individual causality assessment" and "Risk minimisation measures and risk communication" reinforce the theoretical content and teach you how to put knowledge into practice. The final workshop, "Drug safety in the life cycle of a drug", gives you the opportunity to consolidate what you have learned.

This course will helps you to better navigate the diverse responsibilities within drug safety and leads to a qualified certificate.

Detailed programme

Both days: 09:00-17:00 CE(S)T
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

Start of course: Welcome and introduction

09:15

Dr Martin Huber

Introduction to pharmacovigilance
  • What is pharmacovigilance?
  • Information sources
  • How is safety information generated?
  • What does the law say?
  • Good pharmacovigilance practices (GVP)
  • International guidelines

10:30 - 10:45 Coffee break


10:45

Both speakers

Regulatory framework
  • The pharmacovigilance system
  • EU QPPV and local QPPVs
  • Important definitions and abbreviations
  • Pharmacovigilance network: EMA, PRAC, and national authorities

11:45

Both speakers

Quiz: What have we learned?

12:00 - 13:00 Lunch break


13:00

Dr Jutta Syha

Collecting, recording, and reporting
  • Regulatory framework and definitions
  • Documentation and reporting requirements
  • Individual Case Safety Reports (ICSRs)
  • EudraVigilance and EVDAS
  • Single-case causality assessment

14:00

Both speakers

Workshop: Single-case causality assessment

14:45 - 15:00 Coffee break


15:00

Dr Martin Huber

Signal management and safety evaluation
  • Signal management and cumulative evaluation of safety data
  • Causality vs benefit-risk assessment
  • Regulatory toolbox
  • Post-authorisation safety studies (PASS)
  • Benefit-risk assessment - the basics
  • Referral procedures at EU level

16:15

Dr Jutta Syha

Interfaces with other departments
  • Overview
  • Departments including clinical research, regulatory affairs, quality management, sales and marketing, management level etc.
  • Conflict points and solutions

17:00 End of Day 1


09:00

Dr Martin Huber, Dr Jutta Syha

Start of Day 2: Summary of Day 1

09:15

Dr Martin Huber

Risk management in PV
  • The risk management plan (RMP)
  • Identified risks, potential risks, and missing information
  • Routine and additional risk minimisation measures (RMMs)
  • RMP in the life cycle

10:30

Dr Martin Huber

Workshop: Risk minimisation measures and risk communication

11:00 - 11:15 Coffee break


11:15

Dr Jutta Syha

The pharmacovigilance system master file (PSMF)

12:00

Dr Jutta Syha

Quality management in PV
  • Basics of QA systems in PV
  • SOPs, KPIs, CAPAs, and more
  • Who needs to be trained?
  • Documentation and archiving

12:30 - 13:30 Lunch break


13:30

Dr Martin Huber

Periodic safety update report (PSUR)
  • Format, content, and submission requirements
  • PSUR Single Assessment
  • Practical examples

14:30

Dr Jutta Syha

Pharmacovigilance audits and inspections
  • Who inspects, when and what?
  • Exercise: The risk-based audit strategy
  • Inspection readiness

15:15 - 15:30 Coffee break


15:30

Dr Martin Huber

Workshop: Safety in the life cycle of a medicinal product

16:30

Both speakers

Summary and discussion

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!

More 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

    Technical requirements

    You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

    We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

    Access to and procedure for online events

    Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

    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.

    On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

    Learn more about our online events here.

    This distinguishes our events

    of 5 stars of all ratings from 2024

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    In-house seminars

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    Details
    In-house seminars
    List of abbreviations

    Many abbreviations are used in all regulatory areas. Download the list of the most important ones.

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    Testimonials

    I understood basic knowledge and key points to initate any PV linked work.

    Most of the topics weren't new to me, but it was still interesting. It is good that interactive parts are included.

    The event was well-organized and covered important topics in pharmacovigilance over the course of two days.

    Very clear and kind performance. Questions have always been answered very detailed.

    Broad overview of the PV Systems

    It was a nice overview into the different aspects of PV.