2024-05-25 2024-05-25 , online online, 1,890 € zzgl. MwSt. Dr. Martin Huber https://www.forum-institut.de/seminar/24112052-an-introduction-for-pharmacovigilance-managers/referenten/24/24_11/24112052-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. Book 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 aimed at beginners in drug safety with up to one year of work experience in pharmacovigilance. The course primarily caters to former students of medicine or the natural sciences, as well as professionals transitioning from the pharmaceutical industry. In particular, it is addressed to the staff of the following departments:
  • drug safety, patient safety and pharmacovigilance,
  • quality management, clinical research and 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 drug safety in Europe.
  • Classify information on adverse drug reactions before and after market authorisation.
  • 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 drug safety, providing you with essential knowledge to perform your duties in pharmacovigilance.

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 is an ideal opportunity to start a career as a junior PV manager and gain a qualified certificate.

Course An Introduction for Pharmacovigilance Managers

An Introduction for Pharmacovigilance Managers

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 24112052

Jetzt buchen

JETZT Buchen

Referenten


Alles auf einen Blick

Termin

12-13/11/2024

12-13/11/2024

Zeitraum

Both days: 09:00-17:00
You may dial in 30 min. before the session

Both days: 09:00-17:00
You may dial in 30 min. before the session
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. Book 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 aimed at beginners in drug safety with up to one year of work experience in pharmacovigilance. The course primarily caters to former students of medicine or the natural sciences, as well as professionals transitioning from the pharmaceutical industry. In particular, it is addressed to the staff of the following departments:
  • drug safety, patient safety and pharmacovigilance,
  • quality management, clinical research and 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 drug safety in Europe.
  • Classify information on adverse drug reactions before and after market authorisation.
  • 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 drug safety, providing you with essential knowledge to perform your duties in pharmacovigilance.

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 is an ideal opportunity to start a career as a junior PV manager and gain a qualified certificate.

Detailed programme

Both days: 09:00-17:00
You may dial in 30 min. before the session

08:45

Technical test
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00

FORUM Institut

Welcome and introduction

09:15

Dr Martin Huber, Dr Jutta Syha

Introduction to drug safety
  • What is drug safety?
  • Information sources
  • How is safety information generated?
  • The pharmacovigilance system
  • EU QPPV and local QPPVs
  • Important definitions and abbreviations

10:45 Coffee break


11:00

Dr Martin Huber

Regulatory framework
  • Pharmacovigilance network: EMA, PRAC, and national authorities
  • Overview and classification
  • International and European guidelines
  • Good pharmacovigilance practices
  • National requirements in the EU

12:15

Dr Martin Huber, Dr Jutta Syha

Quiz: What have we learned?

12:30 Lunch break


13:30

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

14:30

Dr Jutta Syha

Workshop: Single-case causality assessment

15:00 Coffee break


15:15

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 Day 2 begins


09:00

Dr Martin Huber, Dr Jutta Syha

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

10:15

Dr Martin Huber

Workshop: Risk minimisation measures and risk communication

10:45 Coffee break


11:00

Dr Jutta Syha

The pharmacovigilance system master file (PSMF)

11:30

Dr Martin Huber

Periodic/development safety update reports (PSUR/DSUR)
  • Format, content, and submission requirements
  • Patient exposure and reporting rates
  • Process and project management

12:30 Lunch break


13:30

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

14:30

Dr Jutta Syha

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

15:15 Coffee break


15:30

Dr Martin Huber, Dr Jutta Syha

Workshop: Drug safety in the life cycle of a medicinal product

16:30

Dr Martin Huber, Dr Jutta Syha

Summary and discussion

17:00 End of course


Ihr Nutzen

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.

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List of abbreviations

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

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Abbreviations, Glossary
Testimonials

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We are now officially certified to ISO 9001 and ISO 21001 standard.

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