Pharmacovigilance Key Performance Indicators
KPIs for a robust PV system
- Advanced quality management
- Measure and improve the performance of your PV system
- Includes interactive workshops
- Certified to ISO 9001 and ISO 21001 standards
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ 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.
Buchungsdetails
Online-Seminar
Ab
1.290,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 1.290,-€ 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.
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 to strengthen compliance and inspection readiness. Reserve your seat now and be part of this insightful session!
Your speakers
Claudia Schaffer
Merck Healthcare KGaA, Darmstadt, GERMANY
Senior Director and Head of ICSR Management - Global Patient Safety;
After completing her training, Claudia worked for more than five years as nurse at the Bad…
Your speaker
Claudia Schaffer
Merck Healthcare KGaA, Darmstadt, GERMANY
Senior Director and Head of ICSR Management - Global Patient Safety;
After completing her training, Claudia worked for more than five years as nurse at the Bad Hersfeld Hospital. In 2007, she moved into the field of pharmacovigilance and began her career in data processing. Over time, she took on leadership responsibilities as a team lead in Germany and progressed to become Head of ICSR Management at Merck. In her current role, she leads her international team and improves ICSR management by using digital technologies to make processes more efficient, automated, and user-friendly.
Anika Staack
ARC-Traicoa UG, Überlingen, GERMANY
Founder and PV Expert,
Consultant, EU-QPPV and local QPPV;
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and…
Your speaker
Anika Staack
ARC-Traicoa UG, Überlingen, GERMANY
Founder and PV Expert,
Consultant, EU-QPPV and local QPPV;
Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regarding PV and also for PV inspections. Anika has been working in the pharmaceutical industry since 2003, holding positions of increasing responsibility. She has extensive experience in clinical research operations and holds a Master of Science degree in biology from Marburg University
What to Expect
- Regulatory requirements and best practices
- A step-by-step approach to defining PV KPIs
- Quantitative and qualitative KPIs
- Tracking KPIs
- Presenting KPIs and building dashboards for 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 pharmacovigilance knowledge and/or practical experience is required.
Objective of the Event
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 across global pharmaceutical companies. 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 KPI tracking and dashboard reporting.
- prepares you optimally for the next inspection.
Programme
09:00-17:00 CE(S)T
You can dial in 30 min before the course starts
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
09:15
Anika Staack
- 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
- 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 - 11:00
11:00
Anika Staack
The journey from "quantitative KPIs" to "qualitative KPIs"
11:45
Claudia Schaffer
- PSUR submissions (e.g. timeliness and quality of reports)
- CAPAs and inspection findings
- Signal detection systems
- Handling of safety deviations
- RMP commitments
- Other KPIs
- Supplier management
12:45 - 13:45
13:45
Claudia Schaffer
- Benefits of qualitative KPIs
- How to visualise qualitative KPIs in ICSR management
- Which KPIs are relevant beyond the "mandatory KPIs"?
14:45
Claudia Schaffer
- 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 - 16:00
16:00
Anika Staack
- Quality risk management vs KPIs
- Making a conscious decision against KPIs
- How to document for audits and inspections
16:45
Anika Staack, Claudia Schaffer
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.
Welcome and introduction
09:15
KPI basics
KPI basics
Anika Staack
- KPIs = targets?
- Why do we need KPIs in PV?
- Legal basis of KPIs: GVP modules I and II
- Dimensions of KPIs
09:45
Steps to create KPIs for PV
Steps to create KPIs for PV
Anika Staack
- 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
Coffee break
11:00
Workshop: KPIs and their dimensions
Workshop: KPIs and their dimensions
Anika Staack
The journey from "quantitative KPIs" to "qualitative KPIs"
11:45
Prioritised KPIs
Prioritised KPIs
Claudia Schaffer
- PSUR submissions (e.g. timeliness and quality of reports)
- CAPAs and inspection findings
- Signal detection systems
- Handling of safety deviations
- RMP commitments
- Other KPIs
- Supplier management
Lunch break
13:45
Workshop: KPIs - mandatory and optional
Workshop: KPIs - mandatory and optional
Claudia Schaffer
- Benefits of qualitative KPIs
- How to visualise qualitative KPIs in ICSR management
- Which KPIs are relevant beyond the "mandatory KPIs"?
14:45
Tracking and the dashboard
Tracking and the dashboard
Claudia Schaffer
- 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
Coffee break
16:00
Quality risk management vs KPIs
Quality risk management vs KPIs
Anika Staack
- Quality risk management vs KPIs
- Making a conscious decision against KPIs
- How to document for audits and inspections
Summary, questions and discussion
End of course
Downloads
Request the documents using our form.
Brochure
Brochure - Qualification course Head of Pharmacovigilance
Abbreviation list - Pharmacovigilance
Weitere Informationen
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.
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Further Information
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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