Update your PV writing skills with numerous exercises!
Webcode 25052050
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.
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19-21/05/2025
19-21/05/2025
19 and 21 May: 09:00-17:00 CEST (Note: No session on 20 May)
You may dial in 30 minutes before the session starts.
online
online
Veranstaltung - 1,990 € zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Veranstaltung - 1,990 € 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, you will gain a comprehensive understanding of the regulatory requirements and hands-on experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, avoid common pitfalls, and address global challenges to become a proficient "Pharmacovigilance Writer"!
This two-day online seminar will provide you with a solid understanding of essential pharmacovigilance documents, including the development safety update report (DSUR), periodic safety update report (PSUR), and risk management plan (RMP). You will learn how to create and update these documents across the life cycle of a medicinal product, ensuring compliance with global regulatory requirements. The course covers key regulatory obligations and common challenges in pharmacovigilance writing.
Through practical exercises, you will enhance your writing skills and gain confidence in addressing the complexities of safety documentation. By the end of the seminar, you will be equipped to produce high-quality pharmacovigilance documents, tailored to meet industry standards and best practices. Become a proficient "Pharmacovigilance Writer" now!
By attending this online seminar, you will:
08:45
09:00 Welcome and introduction
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
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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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Tiziana is a really great trainer with a lot of experience and could draw my attention to the topics for the whole time of the course.
Informative and fascinating.
Comprehensive, didatic, very informative and helpful course with great practical exercises lead by a skilled and very experienced trainer.
The instructor (great teacher, not just knowledgeable) and the organisation of the course was very good.
Good presenter.
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.
