Medical Writing in Pharmacovigilance
Seminar
Online
Beschreibung
-
Kursart
Seminar
-
Methodik
Online
This two-day course provides an introduction to medical writing for pharmacovigilance, as well as insights into several relevant safety documents.
Meinungen
Erfolge dieses Bildungszentrums
Sämtlich Kurse sind auf dem neuesten Stand
Die Durchschnittsbewertung liegt über 3,7
Mehr als 50 Meinungen in den letzten 12 Monaten
Dieses Bildungszentrum ist seit 16 Mitglied auf Emagister
Themen
- Risk Management
- Management
Inhalte
Detailed programme
1st Day: 10:00-17:30
2nd Day: 08:30-16:00
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.
Introduction and technical warm-up
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
Detailed programme
1st Day: 10:00-17:30
2nd Day: 08:30-16:00
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.
Introduction and technical warm-up
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
Detailed programme
Detailed programme
1st Day: 10:00-17:30
2nd Day: 08:30-16:00
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.
1st Day: 10:00-17:30
2nd Day: 08:30-16:00
You may dial in 30 min. before the session. The times for breaks at online-seminars are scheduled individually.
Introduction and technical warm-up
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
...
Medical Writing in Pharmacovigilance