2021-12-01 2021-12-01 , Online Online, 660,- € zzgl. MwSt. Dr. Tanja Peters https://www.forum-institut.de/seminar/21122052-pharmacovigilance-in-europe-introductory-e-learning/referenten/21/21_12/21122052-online-training-pharmacovigilance_peters-tanja.jpg Pharmacovigilance in Europe - Introductory e-Learning

Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You can choose between three different packages according to your level of expertise and requirements.

Topics
  • Package I: Drug adverse reactions
  • Sources and reporting timelines, Signal management and PSURs
  • Package II: Risk management
  • RMP, Risk management system, PRAC and risk management in Europe
  • Package III: Pharmacovigilance system
  • PSMF, Quality management, compliance, inspection and audit readiness
Aims and objectives
This e-Learning imparts broad and practical knowledge about all the essentials of European pharmacovigilance in four, eight or 12 recorded webcasts.
This e-Learning consisting of four, eight or twelve recorded webcasts, will build basic knowledge of pharmacovigilance obligations and you will understand what responsibilities are relevant to you. The regulatory basis, important definitions and tasks of drug safety are developed step by step.
Learn all about pharmacovigilance at your own pace, anywhere and at any time.
Acknowledgement: These webcasts were recorded in 2019.
Who should attend

This introductory e-Learning will be of benefit to all those working in pharmacovigilance or in related departments requiring essential European drug safety expertise. Basic pharmaceutical knowledge is recommended but not a prerequisite.

Online training Pharmacovigilance

Pharmacovigilance in Europe - Introductory e-Learning

Benefits
  • Up-to-date expert knowledge
  • Flexibility in location and timing
  • Tests and feedback
  • Certificate of completion
  • Compatibility with mobile devices
  • We are following the IMI quality criteria

Webcode 21122052

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Online

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Sonja Wittemann
Conference Manager

+49 6221 500-696
s.wittemann@forum-institut.de

Details

Do you need to be well versed in European pharmacovigilance for your daily work? Then we recommend this e-Learning. You can choose between three different packages according to your level of expertise and requirements.

Topics
  • Package I: Drug adverse reactions
  • Sources and reporting timelines, Signal management and PSURs
  • Package II: Risk management
  • RMP, Risk management system, PRAC and risk management in Europe
  • Package III: Pharmacovigilance system
  • PSMF, Quality management, compliance, inspection and audit readiness
Aims and objectives

This e-Learning imparts broad and practical knowledge about all the essentials of European pharmacovigilance in four, eight or 12 recorded webcasts.
This e-Learning consisting of four, eight or twelve recorded webcasts, will build basic knowledge of pharmacovigilance obligations and you will understand what responsibilities are relevant to you. The regulatory basis, important definitions and tasks of drug safety are developed step by step.
Learn all about pharmacovigilance at your own pace, anywhere and at any time.
Acknowledgement: These webcasts were recorded in 2019.

Who should attend

This introductory e-Learning will be of benefit to all those working in pharmacovigilance or in related departments requiring essential European drug safety expertise. Basic pharmaceutical knowledge is recommended but not a prerequisite.

Detailed programme


Package I - Drug adverse reactions


1) Introduction to European pharmacovigilance

Recorded webcast from 15 May 2019Dr Tanja Peters
  • History of drug safety
  • Why pharmacovigilance?
  • Important definitions
  • Important health agencies and committees
  • Desired vs. adverse reaction

2) Drug adverse reactions

Recorded webcast from 22 May 2019Dr Christiane Josupeit
  • Sources of drug adverse reactions
  • Causality and benefit-risk assessment
  • Reporting timelines and reporting channels in Europe
  • EudraVigilance

3) Signal management

Recorded webcast from 5 June 2019Dr Ulrich Vogel
  • Signal - An intuitive concept in a regulated framework
  • Signal stages: detection, validation, confirmation, analysis, assessment
  • Statistical and qualitative methods
  • Data collection, decision making and communication
  • EVDAS - a short overview
  • Process implications for the MAH

4) Periodic safety update reports (PSUR)

Recorded webcast from 28 June 2019Sven Schirp
  • For which products are PSURs mandatory?
  • Interval, data lock points and period
  • PSUR format and content
  • Interference with other pharmacovigilance documents
  • How to gather and evaluate data for PSURs


Package II - Risk management


1) Benefit-risk management methodologies

Recorded webcast from 5 September 2019Dr Michael Forstner-Dambenois
  • The concept of risk analysis
  • Qualitative vs. quantitative benefit-risk analysis

2) Risk management plan

Recorded webcast from 10 September 2019Sven Schirp
  • Scope
  • Important definitions
  • Structure & Content
  • Interference with other pharmacovigilance documents

3) Risk management system

Recorded webcast from 8 October 2019Dr Angela van der Salm
  • Pharmacovigilance activities vs. risk minimisation measures
    • GVP Module XVI in detail
  • Risk communication: DHPC, educational material etc
    • Dos & Don'ts in creation and distribution
  • Performance measuring: Post-authorisation safety studies (PASS)

4) PRAC: Understanding the risk management process in Europe

Recorded webcast from 28 October 2019Dr Christian Moers
  • PRAC organisation and process
  • Decision-making and impact on your product
  • Communication with PRAC
  • Referrals


Package III - Pharmacovigilance system


1) Pharmacovigilance system master file (PSMF)

Recorded webcast from 8 November 2019Dr Tanja Peters
  • GVP Module II - Regulatory background
  • Format and content
  • Maintenance at a glance

3) Pharmacovigilance inspection and audit readiness

Recorded webcast from 13 November 2019
Heike von Treichel
  • Fundamentals of inspections and audits: regulations, occurrence, types and aims
  • Strategic planning and preparation - pitfalls
  • Communication with the inspector or auditor
  • Report, typical findings and follow-up measures

2) Quality management and compliance in pharmacovigilance

Recorded webcast from 26 November 2019Dr Angela van der Salm
  • Quality objectives in pharmacovigilance
  • Critical processes
  • Key performance indicators (KPIs)
  • Performance measuring and compliance monitoring

4) Qualified person for pharmacovigilance (QPPV)

Recorded webcast from 12 December 2019Dr Christian Moers
  • Duties and responsibilities
  • Qualifications
  • QPPV vs national responsible person

Trailer

Pharmacovigilance in Europe - Introductory e-Learning

Here you can get a brief insight into the e-Learning Pharmacovigilance in Europe - Introductory e-Learning.

Benefits

Additional benefits

  • Four, eight or 12 recorded webcasts according to your level of expertise and requirements
  • Consolidated information at your work place within a short period of time
  • Modules are available at our e-learning centre for three months
  • Online assessment for certification after each webcast

Fees and booking options

Choose between:

  • One Package, including four recorded webcasts: Fee €660 plus German VAT.

  • Two packages, including eight recorded webcasts: Fee €1,120 plus German VAT.

  • Three packages, including all recorded webcasts: Fee €1,500 plus German VAT.

Individual modules cannot be booked separately. You will receive access information to the e-Learning by email. Would you like to participate as a group? Please contact us. We offer special rates for group registrations.

How does it work

1. Register for an e-learning programme on our website.

2. You will receive an email with your login data for our learning platform.

3. Log in to start your e-learning programme.

4. Complete your e-learning modules at your own pace.

5. Finalise the modules with a multiple-choice test.

6. Once you have successfully completed the tests, you will be awarded a certificate, which you can print out.

Please try out the demo versions of our e-learning programmes free of charge to get an idea of our learning environment.

This distinguishes our events

Overall score of all evaluations in 2020

Five stars on Trustpilot = Excellent

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