2024-10-14 2024-10-14 , online online, 1,190 € plus tax Anika Staack https://www.forum-institut.com/seminar/24102054-pharmacovigilance-key-performance-indicators/referenten/24/24_10/24102054-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.

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.

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

It is primarily intended for PV and quality managers.
Aims and objectives
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 the desired target value is).

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 two workshops
  • Certified to ISO 9001 and ISO 21001 standard

Webcode 24102054

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

21/10/2024

21/10/2024

Period

09:00-17:00 CEST
You can dial in 30 min before the course starts

09:00-17:00 CEST
You can dial in 30 min before the course starts
Venue

online

online

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.

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.

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

It is primarily intended for PV and quality managers.

Aims and objectives

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 the desired target value is).

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 CEST
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

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
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