GMP meets Pharmacovigilance - Live Online Training
Tuesday, 29 October 2024 9 .00 - 17.00 h
Course No. 21356
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Bianca Scholz
ScholzPharma Consulting
Julia Pfaff
Merz Therapeutics
Dr Heinz Weidenthaler
Bavarian Nordic
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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
Testimonials
Seminar Programme as PDF