2024-12-03 2024-12-03 , online online, 1,990 € zzgl. MwSt. Dr. Tiziana von Bruchhausen https://www.forum-institut.de/seminar/25052050-medical-writing-in-pharmacovigilance/referenten/25/25_05/25052050-course-medical-writing-in-pharmacovigilance_von-bruchhausen-tiziana.jpg Medical Writing in Pharmacovigilance

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"!

Topics
  • Best practices, common pitfalls, and cultural challenges in pharmacovigilance writing
  • PV documents throughout the life cycle of a medicinal product: DSUR, RMP, and PSUR
  • Safety concerns and their role in PV documents
  • The role of the pharmacovigilance writer in an interdisciplinary team
  • Practical exercises and lively discussions


Who should attend
This course will be conducted in English.

This online seminar is ideal for professionals in the pharmaceutical industry responsible for preparing and maintaining pharmacovigilance documents such as DSUR, PSUR, and RMP. It is designed for beginners and includes an introduction to the relevant regulatory requirements, along with numerous practical exercises. A basic understanding of the drug development process and pharmacovigilance is recommended.
Aims and objectives
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!
Your benefit

By attending this online seminar, you will:

  • Gain a thorough understanding of DSUR, PSUR, and RMP, including regulatory requirements and guidelines
  • Learn about content, structure, and templates
  • Understand how to align your focus and create synergies with other PV documents
  • Learn about the role of the pharmacovigilance writer in an interdisciplinary team
  • Gain insight into PV activities and risk minimisation measures (RMMs)

Online-Course Medical Writing in Pharmacovigilance

Medical Writing in Pharmacovigilance

Update your PV writing skills with numerous exercises!

Benefits
  • Writing PV-documents: DSUR, PSUR, and RMP
  • Interactive online format with many exercises
  • Practical, first-hand information
  • Officially certified to ISO 9001 and ISO 21001 standard

Webcode 25052050

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Referent


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Termin

19-21/05/2025

19-21/05/2025

Zeitraum

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.

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.
Veranstaltungsort

online

online

Gebühr
Your contact

Nadja Wolff
Conference Manager

+49 6221 500-696
n.wolff@forum-institut.de

Details

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"!

Topics

  • Best practices, common pitfalls, and cultural challenges in pharmacovigilance writing
  • PV documents throughout the life cycle of a medicinal product: DSUR, RMP, and PSUR
  • Safety concerns and their role in PV documents
  • The role of the pharmacovigilance writer in an interdisciplinary team
  • Practical exercises and lively discussions


Who should attend
This course will be conducted in English.

This online seminar is ideal for professionals in the pharmaceutical industry responsible for preparing and maintaining pharmacovigilance documents such as DSUR, PSUR, and RMP. It is designed for beginners and includes an introduction to the relevant regulatory requirements, along with numerous practical exercises. A basic understanding of the drug development process and pharmacovigilance is recommended.

Aims and objectives

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!

Your benefit

By attending this online seminar, you will:

  • Gain a thorough understanding of DSUR, PSUR, and RMP, including regulatory requirements and guidelines
  • Learn about content, structure, and templates
  • Understand how to align your focus and create synergies with other PV documents
  • Learn about the role of the pharmacovigilance writer in an interdisciplinary team
  • Gain insight into PV activities and risk minimisation measures (RMMs)

Detailed programme

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.

08:45

Technical warm-up
You are welcome to log in a little earlier to test the audio and camera before the event begins.

09:00 Welcome and introduction


09:15

Introduction to pharmacovigilance (PV) writing
  • PV activities in the life cycle of a medicinal product
  • Key concepts and terminology relevant for PV documents
  • Definition of PV activities and risk minimisation measures
  • Main PV documents in the life cycle of a medicinal product: Scope and role

10:45 Coffee break


11:00

Introduction to PV writing (continuation)

11:45

English for regulatory PV documents
  • Style and grammar: tips
  • Cultural influence
  • Exercise on English for regulatory documents

12:30 Lunch break


13:30

Development safety update report (DSUR)
  • Regulatory requirements and guidelines
  • Content, structure, template
  • Contributors and role of the PV writer
  • Focus and synergies with other PV documents
  • Exercise: How to present information in DSURs

15:15 Coffee break


15:30

DSUR (continuation)

16:15

Safety concerns
  • Definitions and use in DSUR, RMP, and PSUR
  • Exercise: (Potential) important risks

09:00 Day 2 begins


09:00

Wrap-up of the first day

09:15

Risk management plan (RMP)
  • Regulatory requirements and guidelines
  • Content, structure, and template
  • Contributors and role of the PV writer
  • Focus and synergies with other PV documents
  • Exercise: RMP updates

10:45 Coffee break


11:00

RMP (continuation)

12:30 Lunch break


13:30

Periodic safety update report (PSUR)
  • Regulatory requirements and guidelines
  • Content, structure, template
  • Contributors and role of the PV writer
  • Focus and synergies with other PV documents
  • Exercise: Consistency within PSUR
  • Health Authorities' requests for PSURs

15:15 Coffee break


15:30

PSUR (continuation)

16:00

RMPs and PSURs
  • Scope and guidance expectations
  • Which RMP content should be reflected in the PSUR
  • Life cycle of the safety concerns in RMPs and impact on PSURs
  • Assessment reports of PSURs and impact on RMPs

16:45 Questions and discussion


Kooperationspartner

More information

Pre-meeting and technology check

Familiarise yourself with our Learning Space and gain the confidence you need by attending one of our free pre-meetings. No registration is required. You will find all the pre-meeting dates and the access information in your customer account. Pre-meeting meetings give you the opportunity to explore our Learning Space. This is a non-binding offer for all our customers and not a prerequisite for participation.

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Go forward

Checklist for Medical Writing in PV

Necessary PV documents, contents and a medical writing checklist as a short overview.

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Checklist for Medical Writing in PV
Online training and access to Learning Space

Here you can find information on how to log intro our online seminars.

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Online training
We guarantee the highest quality

We are now officially certified to ISO 9001 and ISO 21001 standard.

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We guarantee the highest quality

Testimonials

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.