Update your PV writing skills with many exercises!
Webcode 24062052
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, Germany
Principal Pharmacovigilance Writer;
Tiziana von Bruchhausen specialised over almost 15 years in pharmacovigilance and gained extensive hands-on experience with the EU Pharma Package. She worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies, covering various roles in a contract research organization and as a freelance writer. She is currently working as a principal pharmacovigilance writer at Boehringer Ingelheim. Her tasks and responsibilities cover pre- and post-submission activities related to the global strategic planning and the preparation of pharmacovigilance documents with a focus on RMPs, PSURs, and their assessment reports.
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.
06-07/06/2024
06-07/06/2024
Both days: 09:00-17:00 CEST
You may dial in 30 min before the session
online
online
Veranstaltung - 1,890 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,890 € 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
Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, gain not just a broad understanding of the regulatory requirements and guidelines, but also practical experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, discover common pitfalls, and tackle global challenges to become a proficient "Pharmacovigilance Writer"!
Various documents are required for pharmaceutical manufacturers in the realm of pharmacovigilance. In addition to the Periodic Safety Management File (PSMF) which describes the whole PV system, there are several safety documents that need to be created and sometimes updated throughout the life cycle of a medicinal product.
Development Safety Update Reports (DSUR) or, post-approval, Periodic Safety Update Reports (PSUR) must regularly evaluate the benefit-risk ratio of medicinal products. A Risk Management Plan (RMP) is developed during the drug development process and needs to be regularly updated throughout its life cycle.
Enhance your skills in this two-day online seminar. Not only gain a general understanding of the obligations and challenges regarding safety documents, but also acquire practical experience in writing PSUR, RMP, and DSUR. Benefit from the extensive experience of our expert and learn about the best practices, common pitfalls, and global challenges. Become a proficient "Pharmacovigilance writer"!
This online seminar will make you knowledgeable about DSUR, PSUR, and RMP regarding...
08:45
09:00
FORUM Institut
09:15
10:45 Coffee break
11:00
11:45
12:30 Lunch break
13:30
15:15 Coffee break
15:30
16:15
09:00 Day 2 begins
09:00 Wrap-up of the first day
09:15
10:45 Coffee break
11:00
12:30 Lunch break
13:30
15:15 Coffee break
15:30
16:45 Questions, discussion and conclusion
of 5 stars of all ratings from 2023
of 5 stars on Trustpilot = good
Dieses Seminar gibt Ihnen Tipps zur besseren Verfahrensbegleitung im MRP und DCP und zum Lifecycle-Management in Europa
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Necessary PV documents, contents and a medical writing checklist as a short overview.
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We are now officially certified to ISO 9001 and ISO 21001 standard.
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The instructor (great teacher, not just knowledgeable) and the organisation of the course was very good.
Good presenter.
Good relevance.
All contens were very useful.
Dr. Tiziana von Bruchhausen has excellent presentation skills from which I could learn a lot. The training was very well organized (also from a technical point of view). Overall, the training exceeded my expectations and I enjoyed it very much.
I was hoping to learn more about DSURs, RMP an PSURs, as they are the most relevant documents for my daily work. My expectaions were exceeded.
