; Course Medical Writing in Pharmacovigilance
2021-12-22 2022-06-23 , Online Online, 1.790,- € plus tax Dr. Tiziana von Bruchhausen https://www.forum-institut.com/seminar/22062050-medical-writing-in-pharmacovigilance/referenten/22/22_06/22062050-course-medical-writing-in-pharmacovigilance_von-bruchhausen-tiziana.jpg Medical Writing in Pharmacovigilance

This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.

Topics
  • Key pharmacovigilance definitions and concepts
  • Scientific, technical or lay language
  • Risk management plan: Contents, structure & requirements
  • Development & Periodic safety update reports: Practical exercises
  • Common pitfalls
Aims and objectives
This two-day online-workshop provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents. You will learn regulatory requirements and how to apply guidelines to prepare pharmacovigilance documents.

In addition, you will learn important aspects of writing and interdisciplinary preparation of pharmacovigilance documents through practical exercises. You will also learn about style and terminology for pharmacovigilance documents (for regulatory, medical and lay public) and will receive tips from expert's practical experience.
Who should attend

This online-workshop is intended for those who work in the pharmaceutical industry and are new to pharmacovigilance writing. Attending this seminar can also serve to refresh knowledge. Participants should have some basic knowledge of the drug development process, of regulatory documentation and of pharmacovigilance.

Online-Course Medical Writing in Pharmacovigilance

Medical Writing in Pharmacovigilance

Update your English writing skills - with many exercises!

Benefits
  • Interactive online format
  • Firsthand information
  • Bilingual Speaker
  • We are following the IMI quality criteria

Webcode 22062050

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JETZT Buchen

Speaker


Everything at a glance

Appointment

22. - 23.06.2022

22. - 23.06.2022

Period

1st Day: 09:00-16:302nd Day: 09:00-1...

1st Day: 09:00-16:30
2nd Day: 09:00-16:30
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.
Venue

Online

Online

Fee
Ihr Ansprechpartner

Sonja Wittemann
Conference Manager

+49 6221 500-696
s.wittemann@forum-institut.de

Details

This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.

Topics
  • Key pharmacovigilance definitions and concepts
  • Scientific, technical or lay language
  • Risk management plan: Contents, structure & requirements
  • Development & Periodic safety update reports: Practical exercises
  • Common pitfalls
Aims and objectives

This two-day online-workshop provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents. You will learn regulatory requirements and how to apply guidelines to prepare pharmacovigilance documents.

In addition, you will learn important aspects of writing and interdisciplinary preparation of pharmacovigilance documents through practical exercises. You will also learn about style and terminology for pharmacovigilance documents (for regulatory, medical and lay public) and will receive tips from expert's practical experience.

Who should attend

This online-workshop is intended for those who work in the pharmaceutical industry and are new to pharmacovigilance writing. Attending this seminar can also serve to refresh knowledge. Participants should have some basic knowledge of the drug development process, of regulatory documentation and of pharmacovigilance.

Detailed programme

1st Day: 09:00-16:30
2nd Day: 09:00-16:30
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.

Day 1 begins

Overview of contents
  • Key pharmacovigilance definitions
  • Development safety update report (DSUR)
  • Risk management plan (RMP)
  • Periodic safety update report (PSUR)/periodic benefit-risk evaluation report (PBRER)
  • English for regulatory documents
  • Medical writing tips
  • Practical exercises

Introduction to pharmacovigilance
  • Definition of key terms relevant for pharmacovigilance documents

Pharmacovigilance documents in the life cycle of a medicinal product: scope and role

DSUR - RMP - PSUR/PBRER
  • Regulatory requirements
  • Guidelines
  • Contents
  • Structure and template
  • Role of the pharmacovigilance writer
  • Interface with other functions; planning aspects
  • Focus, overlap, timing of DSUR, RMP, and PSUR/PBRER
  • Practical exercises

English for regulatory documents
  • Style and terminology
  • Scientific, technical, and lay language
  • Style insights
  • How to enhance readability
  • Common errors and practical exercises

Questions, discussion and conclusions

Kooperationspartner

Seit 2000 bieten wir Expertenwissen zu verschiedenen Rechtsthemen in englischer und deutscher Sprache an. Zu unseren Kernkompetenzen gehören u.a. das Stoff- und Chemikalienrecht sowie das Pharmarecht.

More information

Send us your questions

Please send us your questions concerning the seminar topics in advance.
We will be happy to forward them to the speaker, so that they know about your training requirements even better and are able to answer your questions at the seminar.
Please send your questions to s.wittemann@forum-institut.de

This distinguishes our events

Overall impression: 100% of the participants’ feedback was very good or good (June 2020)

Seminar content: 100% of the participants’ feedback was very good or good (June 2020)

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Our international course portfolio

We provide a variety of international courses for the healthcare industry.

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Our international course portfolio
Technical requirements

Here you can find the technical requirements for our online events that must be met.

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Technical requirements
Quality guaranteed!

Your feedback produced as result of 1.7 in 2020. Thank you!

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More on our quality criteria

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.