2025-03-12 2025-03-12 , , 1,290 € plus tax Anika Staack https://forum-institut.com/seminar/25102055-pharmacovigilance-key-performance-indicators/referenten/25/25_10/25102055-course-pharmacovigilance-key-performance-indicators_staack-anika.jpg Pharmacovigilance Key Performance Indicators

Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way. Reserve your seat now and be part of this insightful session!

Topics
  • Regulatory requirements and best practices
  • Step-by-step guide to PV-related KPIs
  • Quantitative and qualitative KPIs
  • Tracking KPIs
  • Presentation and dashboard - audit readiness
  • Dos and don'ts: The most common mistakes when defining KPIs


Who should attend
This course will be conducted in English.

This online course is designed for pharmaceutical industry professionals involved in the implementation and ongoing adaptation of a PV system. It is primarily intended for PV and quality managers. Basic knowledge and/or practical experience in pharmacovigilance is a prerequisite.
Aims and objectives
Key Performance Indicators (KPIs) can be used to assess and improve the robustness and quality of a PV system. It is essential to clearly define the process metrics (what is being evaluated), the KPI (how it is being measured) and the target (what is the desired target value).

In this online course you will learn about the essential KPIs for PV and the best practices that have been established in big pharma. Take advantage of the interactive training and put your knowledge of quantification to the test.
Your benefit

This online course

  • provides a comprehensive overview of SMART KPIs in pharmacovigilance.
  • provides practical experience of setting up KPIs.
  • describes best practices.
  • enables you to partially automate tracking KPIs and the dashboard.
  • prepares you optimally for the next inspection.

Course - Pharmacovigilance Key Performance Indicators

Pharmacovigilance Key Performance Indicators

KPIs for a robust PV system

Benefits
  • Advanced quality management
  • Measure and improve the performance of your PV system
  • Includes interactive workshops
  • Certified to ISO 9001 and ISO 21001 standards

Webcode 25102055

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

06/10/2025

06/10/2025

Period

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

09:00-17:00 CE(S)T
You can dial in 30 min before the course starts
Venue

Downloads
Fee
Your contact

Nadja Wolff
Conference Manager

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

Details

Are you involved in the implementation and ongoing adaptation of the PV system? In this online course you will learn how to use the right Key Performance Indicators (KPIs) for your PV system in a profitable way. Reserve your seat now and be part of this insightful session!

Topics

  • Regulatory requirements and best practices
  • Step-by-step guide to PV-related KPIs
  • Quantitative and qualitative KPIs
  • Tracking KPIs
  • Presentation and dashboard - audit readiness
  • Dos and don'ts: The most common mistakes when defining KPIs


Who should attend
This course will be conducted in English.

This online course is designed for pharmaceutical industry professionals involved in the implementation and ongoing adaptation of a PV system. It is primarily intended for PV and quality managers. Basic knowledge and/or practical experience in pharmacovigilance is a prerequisite.

Aims and objectives

Key Performance Indicators (KPIs) can be used to assess and improve the robustness and quality of a PV system. It is essential to clearly define the process metrics (what is being evaluated), the KPI (how it is being measured) and the target (what is the desired target value).

In this online course you will learn about the essential KPIs for PV and the best practices that have been established in big pharma. Take advantage of the interactive training and put your knowledge of quantification to the test.

Your benefit

This online course

  • provides a comprehensive overview of SMART KPIs in pharmacovigilance.
  • provides practical experience of setting up KPIs.
  • describes best practices.
  • enables you to partially automate tracking KPIs and the dashboard.
  • prepares you optimally for the next inspection.

Detailed programme

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

08:45

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

Welcome and introduction

09:15

Anika Staack

KPI basics
  • KPIs = targets?
  • Why do we need KPIs in PV?
  • Legal basis of KPIs: GVP modules I and II
  • Dimensions of KPIs

09:45

Anika Staack

Steps to create KPIs for PV
  • A step-by-step approach to PV-related KPIs
  • Departments involved in collecting KPIs
  • Dos and don'ts: Common mistakes when defining KPIs
  • Digression: KPI and supplier management

10:45 Coffee break


11:00

Anika Staack

Workshop: KPIs and their dimensions
The journey from "quantitative KPIs" to "qualitative KPIs"

11:45

Claudia Schaffer

Prioritised KPIs
  • PSUR submissions (e.g. timeliness and quality of reports)
  • CAPAs and inspection findings
  • Signal detection systems
  • Implementation of safety deviations
  • RMP commitments
  • Other KPIs
  • Supplier management

12:45 Lunch


13:45

Claudia Schaffer

Workshop: KPIs - mandatory and optional
  • Benefits of qualitative KPIs
  • How to visualise qualitative KPIs in ICSR management
  • Which KPIs are relevant beyond the "mandatory KPIs"?

14:45

Claudia Schaffer

Tracking and the dashboard
  • Setting up systems for reliable measurement of KPIs
  • Process automation
  • Ways to visualise KPIs (the dashboard)
  • Benefits for audits and inspections
  • KPIs and their purposes (referring to robustness of the PV system)
  • Deriving recommendations for action from KPIs

15:45 Coffee break


16:00

Anika Staack

Quality risk management vs KPIs
  • Quality risk management vs KPIs
  • Making a conscious decision against KPIs
  • How to document for audits and inspections

16:45

Anika Staack, Claudia Schaffer

Summary, questions and discussion

17:00 End of course


More information

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.

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

of 5 stars of all ratings from 2024

of 5 stars on Trustpilot = good

Recommendations

Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a c...

19. - 21.05.2025 in
Details

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 ...

28. - 29.04.2025 in
Details

JCA Dossiers & Joint Clinical Assessments

Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier...

24.03.2025 in
Details

Best practice: project management in GxP

Project management in GxP - Managing projects successfully and efficiently in a regulated environment!

08.04.2025 in
Details

All about ATMP

The online seminar with details on development, quality, CMC, approval and market access (including an update on the upc...

12. - 13.03.2025 in
Details

Go forward

e-Learning - Click and learn

We provide flexible education and training with high-quality e-Learning programmes for several topics.

Details
e-Learning
In-house seminars

Our programmes are also available for in-house training. Just contact us!

Details
In-house seminars
Our rating in 2024

More than 4,000 customers have rated our training courses. Thank you for awarding us 4.3 stars out of 5.

Details
Our rating in 2024

Testimonials

This training has had a signifi cantpositive impact on my personalqualifi cation and also on myprofession.

very helpful - since I needed toimplement a system for PVdeviations I have never heard abouta suffi cient training for PVdeviations and / or CAPAs andwhich KPIs are needed to improvesuch a system - I always found onlydeviations for the QS but I realityyou can not use it 1:1

well organised and comprehensive