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Pharmacovigilance Regulatory Processes – (Certificate)
Université Victor Segalen Bordeaux 2
Eu2P Central Office
| Application Deadline: | October 28, December 12 | ||
| Tuition Fee: | ≈ € 1,500 - | ||
| Location: | Bordeaux / France / View location on map ▾ Hide location on map ▴ | ||
| Duration: | Start Date: | January | |
| Educational Form: |
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| Education Variants: |
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| Credits (ECTS): | 3 | ||
| Languages: | English | ||
Location of Université Victor Segalen Bordeaux 2
Objectives:
- To enable participants (specialists) to develop an understanding of the requirements of Pharmaceutical Industry of the operational aspects of pharmacovigilance as it relates to the preparation of documents legally required by regulatory bodies. Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.
Lecturers
Trainers' team
Dr Sherael Webley, Bharat Amlani [module coordinator] (from University of Hertfordshire), Tara Ferguson, Elisabeth Swain (from GlaxoSmithKline Research and Development Ltd), David Lewis (from Novartis Pharma AG), John Talbot (from AstraZeneca AB) and Justina Orleans-Lindsay (from Acadustri Ltd)
Contents
Topics
- Introduction to case reporting
- Spontaneous reporting
- Ensuring quality within the pharmacovigilance process
- Expedited reporting of individual case safety reports: practical challenges
- Presentation of data and safety evaluation within PSUR
- Writing and reviewing a PSUR
- Development safety update reports (DSUR)
- Contractual arrangements in pharmacovigilance
- Product information/labelling process
- Benefit-risk assessment reports
- Assimilating data for PSUR
- Risk management plans
- New developments in pharmacovigilance
- Workshop: safety evaluation case study
You are normally required to take an English Proficiency Test if you come from a non-English speaking country.
Most European Universities recognise the IELTS test.
More informationRequirements
Educational prerequisite for this module certificate programme:
- Eu2P Certificate in principles of pharmacovigilance and Eu2P Certificate in pharmacovigilance regulations or equivalent level
This Eu2P Certificate programme specificity also requires trainees to
- be fluent in English
- have Internet access and ad hoc computer equipment and be familiar with their use
Additional Requirements
| Minimal degree required: | Bachelor's degree |
| Minimal amount of work experience | Not specified |
Find out more: Request information Visit Programme Website
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