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.
Zielsetzung
In this 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.
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”
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?
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Contacts
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 (0)6221 84 44 35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Mr Maximilian Bauer, +49 (0)6221 84 44 25, bauer@concept-heidelberg.de
Recording from 29 October 2024
Duration of Recording: approx. 5h 47min
Duration of Recording: approx. 5h 47min
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| APIC Member Discount*: | € 1140,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
