Dr Bianca Scholz
ScholzPharma Consulting
Referierende
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
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Zielgruppe
This shortcut is for QPPVs and all employees, specialists and managers of companies and institutions who are responsible for the pharmacovigilance system and/or for the planning and conducting of PV audits / inspections.
Zielsetzung
In recent years, the pharmacovigilance system (PVS) has turned into a highly complex procedure. Numerous regulations require marketing authorization holders to significantly increase PV standards and to review them regularly. For example, the EMA has recently published a new document on follow-up activities following pharmacovigilance inspections.
What are the tasks and responsibilities of the Qualified Person for Pharmacovigilance (QPPV)? How to implement the requirements in practice - correct and inspection-ready? What is the best way to fulfil the requirement to conduct audits and pharmacovigilance inspections?
This shortcut will answer these and other questions and show risk-based approaches on how to deal with the increasing number of audits - e.g. by focusing on audits particularly in critical areas. In this way, time and resources can be saved.
What are the tasks and responsibilities of the Qualified Person for Pharmacovigilance (QPPV)? How to implement the requirements in practice - correct and inspection-ready? What is the best way to fulfil the requirement to conduct audits and pharmacovigilance inspections?
This shortcut will answer these and other questions and show risk-based approaches on how to deal with the increasing number of audits - e.g. by focusing on audits particularly in critical areas. In this way, time and resources can be saved.
Programm
- Role of the QPPV
- Responsibilities of the QPPV
- Review of the PV system / regular audits
- Audits in an international environment:
- Planning
- Preparation
- Execution
- Follow-up of pharmacovigilance inspections: Post-inspection actions and CAPA management
- Remote audits, joint Audits
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Ms Sonja Geppert, +49 6221 84 44-95, geppert@concept-heidelberg.de
Duration of the shortcut: 1h 30m
Recorded in August 2020
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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