NIS, PASS and RWE in the Post-Authorisation Phase
Pharmacovigilance Requirements, Safety Reporting, and Regulatory Requests in Practice
- Practical, EU and US-focused guidance on post-authorisation studies
- Case studies on safety questions and potential signals
- Officially certified to ISO 9001 and ISO 21001
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
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.
Booking details
Online-Seminar
From
1.290,00 €
plus VAT
Services & Process
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.
This one-day online seminar provides a practical, EU-focused overview of NIS, PASS, RWD and RWE and how you select and manage an appropriate study to investigate a safety concern after marketing authorisation.
Speakers
Andreas Lindackers
IQVIA Commercial GmbH & Co. OHG, GERMANY
Solution & Delivery Lead
Real-World Evidence Solutions
Your speaker
Andreas Lindackers
IQVIA Commercial GmbH & Co. OHG, GERMANY
Solution & Delivery Lead
Real-World Evidence Solutions
Anika Staack
ARC-Traicoa UG, 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…
Your speaker
Anika Staack
ARC-Traicoa UG, 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
PD Dr. Thomas Sudhop
-requested-
Senior Expert Information Technology and Clinical Trials, Bonn, GERMANY
Head of Information Technology and Clinical Trials;
Dr Sudhop is a clinical pharmacologist and completed his…
Your speaker
PD Dr. Thomas Sudhop
-requested-
Senior Expert Information Technology and Clinical Trials, Bonn, GERMANY
Head of Information Technology and Clinical Trials;
Dr Sudhop is a clinical pharmacologist and completed his habilitation in the field of lipidology at the University of Bonn. Since 2004, he has been working in the public sector, where he is responsible for clinical trials and information technology. He serves on the examination board of the postgraduate Master's programme in Drug Regulatory Affairs at the University of Bonn and is an active member of the Association for Applied Human Pharmacology (AGAH). From 1999 to 2004, he was a member of the ethics committee of the Medical Association North Rhine. Dr Sudhop is the author of more than 70 scientific publications, including in "The Lancet Oncology", "JAMA", and "Circulation", and has contributed to several chapters in medical textbooks.
What to Expect
- Selecting an appropriate study approach for a defined safety question and product risk profile
- EU and US requirements for post-authorisation studies and relevant national implementation
- Adverse event reporting and signal assessment in the study context
- RWD, RWE and the application of ICH M14
- Responding to regulatory requests and documenting decisions
Who Should Attend
This seminar is designed for professionals in pharmaceutical and biotechnology companies, contract research organisations (CROs), and other service providers involved in planning, conducting, supporting or overseeing post-authorisation studies, including studies using RWD to generate RWE. It is particularly relevant to professionals in pharmacovigilance, clinical affairs, regulatory affairs, and medical affairs.
Objective of the Event
Following marketing authorisation, a safety question may require a post-authorisation study, further analysis of available data, regulatory consultation, or other follow-up activities. Selecting the right approach depends on the question, the evidence available, and the applicable regulatory requirements.
This one-day seminar provides a practical overview of how to plan and manage post-authorisation studies, apply pharmacovigilance requirements and coordinate responsibilities across project teams in the EU and the US. Through practical case studies, the speakers will address study design, adverse event reporting, documentation, signal assessment and communication with competent authorities.
Your Benefit
By the end of the seminar, you will be able to:
- Select and justify an appropriate study approach for a defined post-authorisation safety question.
- Explain the relationship between non-interventional studies and PASS, and assess how RWD and RWE can inform study planning and safety assessment.
- Identify key EU and US requirements, including those in GVP Module VIII (Rev. 3), and determine when national rules need to be considered.
- Apply relevant requirements for safety reporting, follow-up and pharmacovigilance documentation
Programm
09:00-17:00 CE(S)T
You may dial in 30 min before the session starts
You are welcome to log in a little earlier to test your audio and video equipment before the event begins
PD Dr Thomas Sudhop
- NIS, PASS, RWD, and RWE in context
- EU and national requirements
- US requirements and international standard
- Imposed vs voluntary PASS
- GVP Module VIII (Rev. 3
Anika Staack
- Spontaneous reports vs study-related safety reports
- Safety databases, reporting pathways and timelines in the EU, the US and selected European countries
- Data collection, follow-up, and targeted questionnaires in practice
- Documentation and audit trail
- Use of AI
Andreas Lindackers
- Definitions, objectives, and study designs
- EU, US, and selected national requirements
- ICH M14 Guideline
- Data access and data sources in practice
- Data analysis in practice
- Use of AI
All speakers
- Typical questions arising before and after marketing authorisation
- Communication with competent authorities and ethics committees
- Roles and responsibility of sponsors, CROs, and the QPPV
- Documentation, internal decision-making, and escalation
- Key differences between EU and US regulatory approaches
Andreas Lindackers, PD Dr Thomas Sudhop
- Developing an RWD-based approach to safety questions
- Selecting suitable data sources
- Avoiding common pitfalls in NIS and PASS planning
Andreas Lindackers
All speakers
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
Start of course: Welcome and introduction
The EU regulatory framework and international perspective
The EU regulatory framework and international perspective
PD Dr Thomas Sudhop
- NIS, PASS, RWD, and RWE in context
- EU and national requirements
- US requirements and international standard
- Imposed vs voluntary PASS
- GVP Module VIII (Rev. 3
Coffee break
Adverse event reporting in the study context
Adverse event reporting in the study context
Anika Staack
- Spontaneous reports vs study-related safety reports
- Safety databases, reporting pathways and timelines in the EU, the US and selected European countries
- Data collection, follow-up, and targeted questionnaires in practice
- Documentation and audit trail
- Use of AI
Lunch break
Real-world data (RWD) and real-world evidence (RWE)
Real-world data (RWD) and real-world evidence (RWE)
Andreas Lindackers
- Definitions, objectives, and study designs
- EU, US, and selected national requirements
- ICH M14 Guideline
- Data access and data sources in practice
- Data analysis in practice
- Use of AI
Responding to regulatory requests and questions in practice
Responding to regulatory requests and questions in practice
All speakers
- Typical questions arising before and after marketing authorisation
- Communication with competent authorities and ethics committees
- Roles and responsibility of sponsors, CROs, and the QPPV
- Documentation, internal decision-making, and escalation
- Key differences between EU and US regulatory approaches
Coffee break
Workshop: Using ICH M14 to address safety questions
Workshop: Using ICH M14 to address safety questions
Andreas Lindackers, PD Dr Thomas Sudhop
- Developing an RWD-based approach to safety questions
- Selecting suitable data sources
- Avoiding common pitfalls in NIS and PASS planning
Emerging applications of RWD and RWE in post-authorisation safety
Summary and discussion
End of seminar
Downloads
Request the documents using our form.
Abbreviation list Pharmacovigilance
Link list: Drug Safety Navigator
Technical Setup
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.
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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 ‘Details’ 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.
Our Recommendations
Further Information
In-house seminars
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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