Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Dr Bianca Scholz
ScholzPharma Consulting
Julia Pfaff
Merz Therapeutics
Dr Heinz Weidenthaler
Bavarian Nordic
Note: All times mentioned are CET.
Zielsetzung
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”).
Hintergrund
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.
Zielgruppe
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.
Programm
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
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