Update your PV writing skills with numerous exercises!
Webcode 25052050
Dr. Tiziana von Bruchhausen
Boehringer Ingelheim International, Ingelheim, GERMANY
Principal Pharmacovigilance Writer;
Dr Tiziana von Bruchhausen began her career in pharmacovigilance in 2008. Over the years, she has worked as a pharmacovigilance writer for mid-sized and large pharmaceutical companies, held various roles in contract research organisations, and worked as a freelance safety writer.
Currently serving as Principal Pharmacovigilance Writer at Boehringer Ingelheim, her responsibilities encompass both pre- and post-submission activities. These include global strategic planning and the preparation of key PV documents such as RMPs, PSURs, or DSURs.
Dr von Bruchhausen is also an active member of the European Medical Writers Association (EMWA). Since 2017, she has chaired the Pharmacovigilance Special Interest Group Committee. Additionally, she served as EMWA's Vice President from 2017 to 2018 and as President from 2018 to 2019.
More information please click here.
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
09:00
09:15
10:45 Coffee break
11:00
11:45
12:30 Lunch break
13:30
15:15 Coffee break
15:30
16:15
09:15
10:45 Coffee break
11:00
12:30 Lunch break
13:30
15:15 Coffee break
15:30
16:00
16:45 Questions and discussion
17:00 Seminar ends
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.
We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.
of 5 stars of all ratings from 2024
of 5 stars on Trustpilot = good
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central...
Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier...
You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with...
Update your knowledge: Our team of experts provides you with important and practical information about the tasks and res...
ATTENTION: Date change - now 25-26 February 2025 - Will you be involved in the implementation and sustainable maintenanc...
Necessary PV documents, contents and a medical writing checklist as a short overview.
Details
Here you can find information on how to log into our online seminars.
Details
We are now officially certified to ISO 9001 and ISO 21001 standard.
Details
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.
