The advanced course in Risk Management
Webcode 24112051
Dr. Martin Huber
Senior Expert Pharmacovigilance, Bonn, Germany
Senior Expert Pharmacovigilance German PRAC member
Anika Staack
ARC-Traicoa UG, Überlingen, Germany
Freelancer, EU-QPPV and local QPPV; Anika Staack serves as EU-QPPV and local QPPV. In this role, she is responsible for establishing and maintaining of pharmacovigilance systems as well as ensuring compliance and meeting quality standards of PV operations. She acts as contact point for regulatory authorities in regards to PV and also for PV inspections. Anika has held positions of increasing responsibility for the past 15 years in the pharmaceutical industry, with extensive experience in the clinical research operations sector. Anika holds a Master of Science degree in biology from Marburg University.
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, GERMANY
Principal Pharmacovigilance Writer;
Tiziana von Bruchhausen has over 15 years of experience in pharmacovigilance writing. She worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies in a contract research organization and as a freelance writer. In her current position, her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents (DSURs, RMPs, PSURs, Addendum to Clinical Overview).
Tiziana is an active volunteer at the European Medical Writers Association (EMWA), where she has been chairing the Pharmacovigilance Special Interest Group Committee since 2017. She was Vice President of EMWA in 2017-2018 and President in 2018-2019.
More information please click here.
06/11/2024
06/11/2024
09:00-17:00 CET
You may dial in 30 min before the session
online
online
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,190 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Nadja Wolff
Conference Manager
+49 6221 500-696
n.wolff@forum-institut.de
- GVP Module XVI Risk minimisation measures (Rev 3) came into force - Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!
This seminar deepens your knowledge in RMP and PSUR preparation, assessment and regulatory management.
The updated GVP Module XVI - Risk minimisation measures (Rev 3) came into force on 6 August 2024. The FORUM Institute and our speakers guarantee that we will incorporate all updates into the training in an understandable way!
By attending this seminar, you will refresh your knowledge of the current European guidelines according to EMA Modules V and XVI. You will also learn new aspects of safety concerns and best practices for additional risk minimisation measures.
Take a look at pharmacovigilance documents from a QPPV perspective and benefit from our speakers' many years of experience with global authorities or in writing and harmonising RMP and PSUR!
After completing the online seminar, you will
08:45
09:00
09:15
Dr Tiziana von Bruchhausen
09:45
Dr Tiziana von Bruchhausen, Dr Martin Huber
10:30 Coffee break
10:45
Dr Tiziana von Bruchhausen, Dr Martin Huber
11:15
Anika Staack
11:45
Dr Martin Huber
12:15 Lunch break
13:15
Dr Tiziana von Bruchhausen
13:45
Anika Staack
14:15
Anika Staack
15:00 Coffee break
15:15
Dr Martin Huber
16:00
Anika Staack
16:45
All speakers
17:00 Seminar ends
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
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Necessary PV documents, contents and a medical writing checklist as a short overview.
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Many abbreviations are used in all regulatory areas. Download the list of the most important ones.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
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Comments of participants (March 2020)
Since I am relatively new to the field, I wanted to learn more about RMP and PSUR life cycle management in general. I learned many things that I can use for my daily work. The seminar met my expectations.
My expectations were to have an open discussion on these matters and to check if we, as a company, are aligned with the other companies. these were fully met.
My initial expectations were about the identification of the important safety concerns according to the new GVP module V rev.2 and the identification of the additional PV activities and their possible effectiveness measures. All topics were discussed with a high level of detail.
The interaction between speakers and the content; was very lively.
The great interactions.
This is what participants in (November 2018) liked most about the event.
Topics, interactive presentations.
