Speakers

Dr. Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Dr Heinz Weidenthaler

Bavarian Nordic

Dr Bianca Scholz

ScholzPharma Consulting

Julia Pfaff

Merz Therapeutics

Note: All times mentioned are CET.

Objectives

In this live online training, you will learn from experienced experts what you need to consider as a Qualified Person for Pharmacovigilance (QPPV). You will receive information on similarities and demarcations with other roles, like Qualified Persons (QPs), Information Officers and the German graduated plan officer (“Stufenplanbeauftragter”).

Background

The systematic recording, collection and evaluation of Reports on adverse drug reactions as well as quality defects and falsifications are the main tasks of the QPPV in the context of drug safety. The establishment and maintenance of a pharmacovigilance system (PVS), reviewing the PVS with the help of audits, as well as the preparation, monitoring and follow-up of Authority inspections are also part of the QPPV tasks. QPPVs also have an important function in the event of complaints and recalls. This include direct contact with the authorities in Connection with processing quality defects, including analysing the causes, the description of corrective and preventive measures, as well as the preparation of regularly updated safety Reports (PSURs) and the implementation of safety variations.

Target Group

This course is designed for:

Qualified Persons Responsible for Pharmacovigilance (QPPVs)
Qualified Persons (QPs),
Sponsors of clinical trials,
Individuals involved in GVP inspections & audits, complaint handling, and signal & data Management.

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

GMP meets Pharmacovigilance - Live Online Training

Seminar Programme as PDF

Complaints & Recalls: GMP Requirements

Do we know the definitions of complaint and recall?
EU GMP Part I chapter 8
Difference within EU GMP cocnerning IMPs and ATMPs
News from the Compilations of Union Procedures
Recall as a risk mitigating measure
Mock Recall
Examples

The QP Involvement and Perspective on Pharmacovigilance

The QP and the QPPV - similar roles?
Technical complaints and safety Signals
Who decides? Expectations.
Spectrum of national legal differences within EU
Examples and experience sharing

Interfaces & Demarcations - The QPPV Perspective

Responsible persons according to GMP, GDP and GVP

Tasks and obligations of the QPPV, QP and GDP responsible Person
Interfaces between QPPV, QP and GDP responsible Person during daily practice
Examples from daily Business
Special case in Germany – “Stufenplanbeauftragter”

Q&A Session 1

GVP Inspections & Audits

Expectations for GMP/GVP interfaces in audits and inspections
Typical findings in GMP/GVP collaboration/interface
Relevant contracts in the interfacial daily business QP/QPPV
Inspection readiness do’s and don’ts

Real-World Data and Signal Management

Data sources in the post-authorization phase, solicited versus unstructured data
Study designs in real-world Settings
Understanding and analyzing large datasets, Signal algorithms versus manual assessment
Assessing the impact of safety findings on the benefit Risk profile

Safety Variations and Risk Minimization Measures

When the alarm bell rings: a safety signal is verified, what to do next?
Internal process requirements and external reporting obligations
Prioritization of safety variations
Is a labeling update sufficient to prevent further onset of adverse reactions? What is the role of additional Risk minimization measures?

Q&A Session 2

ECA-Member*:	€ 1090,-
Regular Fee*:	€ 1190,-
EU/GMP Inspectorates*:	€ 595,-
APIC Member Discount*:	€ 1140,-

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

Further dates on-site

Further dates on-site
Not available

Further dates online

Further dates online
Not available

Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
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“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
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“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
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GMP meets Pharmacovigilance - Live Online Training