2024-05-25 2024-05-25 , online online, 1,890 € zzgl. MwSt. Dr. Tiziana von Bruchhausen https://www.forum-institut.de/seminar/24062052-medical-writing-in-pharmacovigilance/referenten/24/24_06/24062052-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, 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"!

Topics
  • Pharmacovigilance Writing: Best practices, common pitfalls, and cultural challenges
  • PV documents in the life cycle of a medicinal product: DSUR, RMP, and PSUR
  • Safety concerns and their use in PV documents
  • 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 beneficial for those in the pharmaceutical industry preparing and maintaining pharmacovigilance writing documents such as DSUR, PSUR, and RMP. It is a beginner course that includes the relevant regulatory requirements and many practical exercises. Familiarity with the drug development process and pharmacovigilance is recommended for participants.
Aims and objectives
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"!
Your benefit

This online seminar will make you knowledgeable about DSUR, PSUR, and RMP regarding...

  • the regulatory requirements and guidelines.
  • content, structure, and templates.
  • focus and synergies with other PV documents.
  • the role of the pharmacovigilance writer in an interdisciplinary team.
  • PV activities and risk minimization measures (RMMs).

Online-Course Medical Writing in Pharmacovigilance

Medical Writing in Pharmacovigilance

Update your PV writing skills with many exercises!

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

Webcode 24062052

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Referent


Alles auf einen Blick

Termin

06-07/06/2024

06-07/06/2024

Zeitraum

Both days: 09:00-17:00 CEST
You may dial in 30 min before the session

Both days: 09:00-17:00 CEST
You may dial in 30 min before the session
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, 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"!

Topics

  • Pharmacovigilance Writing: Best practices, common pitfalls, and cultural challenges
  • PV documents in the life cycle of a medicinal product: DSUR, RMP, and PSUR
  • Safety concerns and their use in PV documents
  • 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 beneficial for those in the pharmaceutical industry preparing and maintaining pharmacovigilance writing documents such as DSUR, PSUR, and RMP. It is a beginner course that includes the relevant regulatory requirements and many practical exercises. Familiarity with the drug development process and pharmacovigilance is recommended for participants.

Aims and objectives

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"!

Your benefit

This online seminar will make you knowledgeable about DSUR, PSUR, and RMP regarding...

  • the regulatory requirements and guidelines.
  • content, structure, and templates.
  • focus and synergies with other PV documents.
  • the role of the pharmacovigilance writer in an interdisciplinary team.
  • PV activities and risk minimization measures (RMMs).

Detailed programme

Both days: 09:00-17:00 CEST
You may dial in 30 min before the session

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

FORUM Institut

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
  • From the safety database to PV documents
  • Definition of PV activities and risk minimization measures
  • PV writing: expertise, knowledge, skills

10:45 Coffee break


11:00

PV documents in the life cycle of a medicinal product: Scope & role
  • Development Safety Update Report (DSUR)
  • Risk Management Plan (RMP)
  • Periodic Safety Update Report (PSUR)

11:45

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

12:30 Lunch break


13:30

DSUR
  • Regulatory requirements and guidelines
  • Content, structure, template
  • Focus and synergies with other PV documents
  • Role of the pharmacovigilance writer in an interdisciplinary team
  • Exercise

15:15 Coffee break


15:30

DSUR (continuation)

16:15

Safety concerns
  • Definitions and use in DSUR, RMP, and PSUR
  • Exercise

09:00 Day 2 begins


09:00 Wrap-up of the first day


09:15

RMP
  • Regulatory requirements and guidelines
  • Content, structure, template
  • Examples of PV activities and risk minimization measures
  • Focus and synergies with other PV documents
  • Role of the pharmacovigilance writer in an interdisciplinary team
  • RMP updates
  • Exercise
  • Life cycle of the safety concerns in RMPs and impact on PSURs

10:45 Coffee break


11:00

RMP (continuation)

12:30 Lunch break


13:30

PSUR
  • Regulatory requirements and guidelines
  • Content, structure, template
  • Consistency within PSUR
  • Exercise
  • Focus and synergies with other PV documents
  • Health Authorities' requests for PSURs
  • Role of the pharmacovigilance writer in an interdisciplinary team
  • Exercise
  • Planning: global vs local PSUR

15:15 Coffee break


15:30

PSUR (continuation)

16:45 Questions, discussion and conclusion


Kooperationspartner

More information

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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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Online training and access to Learning Space

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

Details
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


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.