Pharmacovigilance Inspections/Audits & the Role of the QPPV - Webinar Recording

Pharmacovigilance Inspections/Audits & the Role of the QPPV - Webinar Recording

Costs

ECA-Member*: EUR 199,--
Regular Fee*: EUR 249,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Bianca Scholz, Germany, ScholzPharma GmbH, Consulting, Audit & Projectmanagement

Background

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 webinar 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.

Target Group

This webinar 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.

Technical Details

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:

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:

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.

Programme

  • 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

Recording from 19 August 2020
Duration of recording: about 1,5 h
.

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