Quality Management in Pharmacovigilance Systems
Best Practices for Meeting GVP Module I Requirements
- A compact overview of QM in PV
- GVP Modul I, SOPs, KPIs, CAPAs and more
- Highly recommend from former participants
- Officially certified to ISO 9001 and ISO 21001
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 with an additional certificate upon passing.
Period:
09:00-17:00 CE(S)T
You may join the session 30 minutes before
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 with an additional certificate upon passing.
Period:
09:00-17:00 CE(S)T
You may join the session 30 minutes before
This intensive one-day online course provides practical guidance on implementing the quality requirements of GVP Module I and on monitoring and optimising your pharmacovigilance system.
Speakers
Dr. Petra Lerner-Hiller
Senior Expert Pharmacovigilance, Darmstadt
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, PV System & QPPV Relations Lead;
Dr Petra Lerner-Hiller has more than 25 years of experience in leading…
Your speaker
Dr. Petra Lerner-Hiller
Senior Expert Pharmacovigilance, Darmstadt
Senior PV Auditor, PV Quality Consultant, Deputy QPPV, PV System & QPPV Relations Lead;
Dr Petra Lerner-Hiller has more than 25 years of experience in leading positions in the pharmaceutical industry in the areas of quality assurance (GVP, GCP) and pharmacovigilance, including the functions of German "Stufenplanbeauftragte" and EU QPPV. In her current role, Dr Lerner-Hiller is Deputy QPPV and also PV System Strategy and QPPV Relations Lead, responsible for the strategic oversight of the pharmacovigilance system including its quality management system and communication with local QPPVs worldwide.
Dr. Sabine Poltermann
Bristol Myers Squibb AG
Head of Country Patient Safety Switzerland and Liechtenstein
Dr Sabine Poltermann is a veterinarian with an extensive background in pharmacovigilance. She has experience from…
Your speaker
Dr. Sabine Poltermann
Bristol Myers Squibb AG
Head of Country Patient Safety Switzerland and Liechtenstein
Dr Sabine Poltermann is a veterinarian with an extensive background in pharmacovigilance. She has experience from various companies at local, regional and global level, including CROs, generics and originator companies. She has also worked in the areas of digital governance and agile product development, as well as several years as an information officer. Dr Sabine Poltermann has been Head of Country Patient Safety in Switzerland and Liechtenstein since April 2023. In addition to her professional expertise, she is a qualified trainer and coach and is actively involved in several professional associations.
What to Expect
- Key components and processes of the PV quality system
- Proper documentation and archiving of critical processes
- Organisation, responsibility, and delegation
- Effective monitoring
- Training, audits, CAPA and more
Who Should Attend
This course wil be conducted in English.
The online seminar is aimed at pharmaceutical manufacturing personnel involved in the implementation, review and ongoing adaptation of the PV system. It is particularly relevant for professionals working in pharmacovigilance, compliance and quality assurance, as well as those working at the intersection of these fields.
Previous knowledge of pharmacovigilance is recommended.
Objective of the Event
A well-organised quality system is the essential basis for a functioning pharmacovigilance system. However, when it comes to practical implementation in pharmaceutical companies, questions often arise:
- What are the requirements of the PV system?
- How do I measure quality?
- How should I tread critical processes?
- What can be delegated?
- How do I document and archive?
Our experienced trainers will work with you to cut through the complexity of the PV system and give you a good overview of all aspects relevant to quality with many practical examples. Ask questions at any time and actively participate in the discussions!
Your Benefit
Our speakers will show you how your PV system can meet the quality requirements and how it can be improved over time.
After the seminar you will...
- understand the key compliance requirements under EU legislation and GVP.
- identify the key performance indicators (KPIs) required to monitor pharmacovigilance processes.
- plan training for pharmacovigilance personnel and ensure that it is properly documented
- prepare for audits and inspections of your organisation and service providers, and address findings through appropriate CAPA.
After the seminar, you will receive a confirmation of attendance. You will also have the opportunity to take an online test, with multiple attempts available. Upon passing the test, you will receive an additional certificate.
Programm
09:00-17:30 CE(S)T
You may join the session 30 minutes before
08:00 - 09:00
You are welcome to log in a little earlier to test the audio and camera before the event begins
09:00
09:15
Dr Petra Lerner-Hiller
- Overview of the legal framework
- Good Pharmacovigilance Practices (GVP)
- GVP Module I: Pharmacovigilance and Quality System
- GVP Module II: The Pharmacovigilance Master File (PSMF)
10:00
Dr Sabine Poltermann
- Principles and objectives of a quality management system
- Identification of "critical" processes
- Standard operating procedures (SOPs)
10:45 - 11:00
11:00
Dr Sabine Poltermann
- Ensuring processes and documentation remain up to date
- Documentation of the QMS
- Practical case studies
12:00 - 13:00
13:00
Dr Petra Lerner-Hiller
- Which parts of the organisation are included in the PV system?
- QPPV responsibilities: What must be handled personally, and what can be delegated?
- Proper documentation of delegation - Practical examples
- Effective resource management - Practical insights
14:15
Dr Petra Lerner-Hiller
- Efficient monitoring of the PV system, including internal processes, license partners, and service providers
- Key Performance Indicators (KPIs) and their role in compliance
- Practical examples
- Common findings during inspections and how to address them
15:00 - 15:15
15:15
Dr Sabine Poltermann
- Who requires training and on which topics?
- Assessing learning effectiveness
- Proper documentation
15:45
Dr Sabine Poltermann
- What must be documented and archived?
- Archiving methods and regulatory requirements
- Retention periods
- Ensuring timely availability of documentation
16:15
Dr Sabine Poltermann
- Pharmacovigilance audits
- Risk based audit approach and planning
- Effective corrective and preventive actions (CAPA)
16:45
17:00
08:00 - 09:00
Technical test
Technical test
You are welcome to log in a little earlier to test the audio and camera before the event begins
Start of course: Welcome and introduction
09:15
Regulatory framework for PV and QM systems
Regulatory framework for PV and QM systems
Dr Petra Lerner-Hiller
- Overview of the legal framework
- Good Pharmacovigilance Practices (GVP)
- GVP Module I: Pharmacovigilance and Quality System
- GVP Module II: The Pharmacovigilance Master File (PSMF)
10:00
Key components and processes of the PV quality system
Key components and processes of the PV quality system
Dr Sabine Poltermann
- Principles and objectives of a quality management system
- Identification of "critical" processes
- Standard operating procedures (SOPs)
Coffee break
11:00
Maintaining and Documenting the Pharmacovigilance Quality System
Maintaining and Documenting the Pharmacovigilance Quality System
Dr Sabine Poltermann
- Ensuring processes and documentation remain up to date
- Documentation of the QMS
- Practical case studies
Lunch break
13:00
Organisation, responsibility, and delegation
Organisation, responsibility, and delegation
Dr Petra Lerner-Hiller
- Which parts of the organisation are included in the PV system?
- QPPV responsibilities: What must be handled personally, and what can be delegated?
- Proper documentation of delegation - Practical examples
- Effective resource management - Practical insights
14:15
Compliance and monitoring
Compliance and monitoring
Dr Petra Lerner-Hiller
- Efficient monitoring of the PV system, including internal processes, license partners, and service providers
- Key Performance Indicators (KPIs) and their role in compliance
- Practical examples
- Common findings during inspections and how to address them
Coffee break
15:15
Training
Training
Dr Sabine Poltermann
- Who requires training and on which topics?
- Assessing learning effectiveness
- Proper documentation
15:45
Documentation and archiving
Documentation and archiving
Dr Sabine Poltermann
- What must be documented and archived?
- Archiving methods and regulatory requirements
- Retention periods
- Ensuring timely availability of documentation
16:15
Audits and CAPA management
Audits and CAPA management
Dr Sabine Poltermann
- Pharmacovigilance audits
- Risk based audit approach and planning
- Effective corrective and preventive actions (CAPA)
Summary, questions, and closing discussion
End of course
Downloads
Request the documents using our form.
Abbreviation list: Pharmacovigilance
Link list: Drug Safety Navigator
Further Information
An interactive seminar with learning assessment and certificate
This event offers a combination of solid theoretical principles, practical workshops, and interactive discussions. To maximise your learning experience, we kindly ask you to keep your camera on whenever possible and actively participate.
After completing the seminar, you will have the opportunity to take a multiple-choice test in the Learning Space to assess your learning progress. Upon successfully passing the test, you will receive a certificate recognized for its compliance with inspection standards, along with your certificate of attendance.
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.
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 is what distinguishes this event
A proven German-language seminar, now available in English.
Up-to-date content on current regulations and best practices.
Our Recommendations
Masterclass: Local QPPV, EU QPPV, and Head of PV
This one-day masterclass offers experienced experienced PV professionals practical insights into PV system management, leadership and inspection readiness, combined with high-level peer exchange.Sprache: Englisch
Corrective and Preventive Action (CAPA) in der Pharmakovigilanz
Dieses Seminar vermittelt praxisnah, wie Sie Abweichungen mithilfe der Root Cause Analysis analysieren und CAPAs in der Pharmakovigilanz risikobasiert planen, umsetzen und dokumentieren.Sprache: Deutsch
Further Information
In-house seminars
Our programmes are also available for in-house training. Just contact us!
Newsletter on trends and findings
Stay up to date - we regularly inform you about new regulatory and professional developments.
We guarantee the highest quality
We are now officially certified to ISO 9001 and ISO 21001 standard.
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