An Introduction for Pharmacovigilance Managers
Core Concepts of Drug Safety
- Condensed overview of pharmacovigilance
- Delivered by two PV experts with different professional backgrounds
- Interactive format
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
Ab
2.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 2.090,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test including a certificate upon passing.
Period:
Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts.
Buchungsdetails
Online-Seminar
Ab
2.090,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 2.090,-€ zzgl. MwSt.
The fee includes course material and a participation certificate for download, access to the Learning Space, technical support and a standardised online test including a certificate upon passing.
Period:
Both days: 09:00-17:00 CE(S)T
You may dial in 30 min before the course starts.
This intensive two-day online course provides a concise yet comprehensive overview of core pharmacovigilance activities, EU regulatory requirements, and their practical implementation.
Your speakers
Dr. Martin Huber
-requested-
Senior Expert Pharmacovigilance, GERMANY
Head of Pharmacovigilance; Head of "PRAC, Legal Classification, Adverse Reaction Reporting, Medication Safety (AMTS)" and former PRAC Member;
Dr.…
Your speaker
Dr. Martin Huber
-requested-
Senior Expert Pharmacovigilance, GERMANY
Head of Pharmacovigilance; Head of "PRAC, Legal Classification, Adverse Reaction Reporting, Medication Safety (AMTS)" and former PRAC Member;
Dr. Huber is a pharmacist and public health professional with many years of experience spanning clinical practice, public administration, and committee work. After completing his studies and spending three years at Zurich University Hospital, he has worked in public administration since 2010. He has been a delegate to the Pharmacovigilance Risk Assessment Committee (PRAC) since 2012 and served as its Deputy Chair from 2018 to 2024. In addition, he chairs the CMDh Task Force on non-prescription medicines. Dr. Huber is an associate member of the Drug Commission of the German Medical Association (AkdÄ) and is active in several professional societies, including ISoP, DGRA, DPhG, and DGPPN.
Dr. Jutta Syha
Dr. Syha Pharmaconsult, GERMANY
Founder and owner;
Dr Syha contributes her experience in pharmacovigilance to various projects. After 20 years, she has a broad knowledge in the field and has been…
Your speaker
Dr. Jutta Syha
Dr. Syha Pharmaconsult, GERMANY
Founder and owner;
Dr Syha contributes her experience in pharmacovigilance to various projects. After 20 years, she has a broad knowledge in the field and has been entrusted with various tasks, including EU QPPV and Graduate Plan Officer.
What to Expect
- 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 professionals who need a clear and compact overview of all key pharmacovigilance activities. It is suitable for those at an early stage of their drug safety career as well as for experts from related areas who wish to broaden or refresh their knowledge of the full pharmacovigilance system. It is particularly relevant for staff working in
- drug safety, patient safety, pharmacovigilance,
- quality management, clinical research, medical affairs and regulatory affairs,
- as well as for graduates in medicine or life sciences who are moving into these functions.
Objective of the Event
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.
Programme
Both days: 09:00-17:00 CET
You may join the session 30 minutes before
Day 1
08:45 - 09:00
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.
09:00
FORUM Institut
09:15
Dr Martin Huber
- What is pharmacovigilance?
- Information sources
- How is safety information generated?
- What does the law say?
- Good pharmacovigilance practices (GVP)
- International guidelines
- Pharmacovigilance network: EMA, PRAC, and national authorities
10:30 - 10:45
10:45
Dr Jutta Syha
- The pharmacovigilance system
- EU QPPV and local QPPVs
- Important definitions and abbreviations
11:45
Both speakers
12:00 - 13:00
13:00
Dr Jutta Syha
- Regulatory framework and definitions
- Documentation and reporting requirements
- Individual case safety reports (ICSRs)
- SUSARs and reporting in clinical trials
- EudraVigilance and EVDAS
- Single-case causality assessment
14:00
Both speakers
14:45 - 15:00
15:00
Dr Martin Huber
- 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
- Overview
- Departments including clinical research, regulatory affairs, quality management, sales and marketing, management level etc.
- Conflict points and solutions
17:00
08:45 - 09:00
Technical warm-up
Technical warm-up
You are welcome to log in a little earlier to test your audio and video equipment before the event begins.
Start of course: Welcome and introduction
09:15
Introduction to pharmacovigilance
Introduction to pharmacovigilance
Dr Martin Huber
- What is pharmacovigilance?
- Information sources
- How is safety information generated?
- What does the law say?
- Good pharmacovigilance practices (GVP)
- International guidelines
- Pharmacovigilance network: EMA, PRAC, and national authorities
Coffee break
10:45
Regulatory framework
Regulatory framework
Dr Jutta Syha
- The pharmacovigilance system
- EU QPPV and local QPPVs
- Important definitions and abbreviations
Quiz: What have we learned?
Lunch break
13:00
Collecting, recording, and reporting
Collecting, recording, and reporting
Dr Jutta Syha
- Regulatory framework and definitions
- Documentation and reporting requirements
- Individual case safety reports (ICSRs)
- SUSARs and reporting in clinical trials
- EudraVigilance and EVDAS
- Single-case causality assessment
Workshop: Single-case causality assessment
Coffee break
15:00
Signal management and safety evaluation
Signal management and safety evaluation
Dr Martin Huber
- 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
Interfaces with other departments
Interfaces with other departments
Dr Jutta Syha
- Overview
- Departments including clinical research, regulatory affairs, quality management, sales and marketing, management level etc.
- Conflict points and solutions
End of Day 1
Day 2
09:00
Dr Martin Huber, Dr Jutta Syha
09:15
Dr Martin Huber
- The risk management plan (RMP)
- Identified risks, potential risks, and missing information
- Routine and additional risk minimisation measures (RMMs)
- RMP in the life cycle: Pre- and post-approval
10:30
Dr Martin Huber
11:00 - 11:15
11:15
Dr Jutta Syha
12:00
Dr Jutta Syha
- Basics of QA systems in PV
- SOPs, KPIs, CAPAs, and more
- Who needs to be trained?
- Documentation and archiving
12:30 - 13:30
13:30
Dr Martin Huber
- Format, content, and submission requirements
- PSUR single assessment
- Practical examples
- Development safety update report (DSUR)
14:30
Dr Jutta Syha
- Who inspects, when and what?
- Exercise: The risk-based audit strategy
- Inspection readiness
15:15 - 15:30
15:30
Dr Martin Huber
16:30
Both speakers
17:00
Start of Day 2: Summary of Day 1
09:15
Risk management in PV
Risk management in PV
Dr Martin Huber
- The risk management plan (RMP)
- Identified risks, potential risks, and missing information
- Routine and additional risk minimisation measures (RMMs)
- RMP in the life cycle: Pre- and post-approval
Workshop: Risk minimisation measures and risk communication
Coffee break
The pharmacovigilance system master file (PSMF)
12:00
Quality management in PV
Quality management in PV
Dr Jutta Syha
- Basics of QA systems in PV
- SOPs, KPIs, CAPAs, and more
- Who needs to be trained?
- Documentation and archiving
Lunch break
13:30
Periodic safety update report (PSUR)
Periodic safety update report (PSUR)
Dr Martin Huber
- Format, content, and submission requirements
- PSUR single assessment
- Practical examples
- Development safety update report (DSUR)
14:30
Pharmacovigilance audits and inspections
Pharmacovigilance audits and inspections
Dr Jutta Syha
- Who inspects, when and what?
- Exercise: The risk-based audit strategy
- Inspection readiness
Coffee break
Workshop: Safety in the life cycle of a medicinal product
Summary and discussion
End of course
PV Knowledge Check
Simply click on the answer you think is correct.
Downloads
Request the documents using our form.
Abbreviation list Pharmacovigilance
Link list Drug Safety Navigator
Further Informations
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 is what distinguishes this event
The overall impression of the event was rated 5/5 stars.
(October 2025)
The event materials were rated 5/5 stars.
(October 2025)
Customer Testimonials
What satisfied participants say
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Further Information
In-house seminars
Our programmes are also available for in-house training. Just contact us!
List of abbreviations
Many abbreviations are used in all regulatory areas. Download the list of the most important ones.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
Your Contact Person
We are happy to advise you personally and individually.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de