PRINCIPLES OF PHARMACOVIGILANCE
MODULE OVERVIEW
| Objectives | To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-marketing environment and the roles of various stakeholders within pharmacovigilance. |
|---|---|
| Topics |
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| Keywords | Introduction, regulations, legislation, principles |
| Level | Introductory |
| Trainers' team | Christopher Benham [module coordinator], Dr Sherael Webley (from University of Hertfordshire), Tara Ferguson, Elisabeth Swain, Wendy Brewster, Steve Hobbiger (from GlaxoSmithKline Research and Development Ltd), David Lewis, Andy Cochrane, Phil Close (from Novartis Pharma AG) and John Talbot (from AstraZeneca AB) |
| Workload | 3 ECTS credits |
| Training mode | e-learning |
| Language | English |
| Eu2P training affiliation |
Certificate in Medicines pharmacovigilance and regulatory aspects Master Year 1 |
CERTIFICATE PROGRAMME REGISTRATION
PROFILE & PREREQUISITES
- Educational prerequisite for this module certificate programme:
Graduate degree or working experience in clinical, scientific or regulatory field or clinical experience (e.g. nurses)
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
KEY DATES & COURSE CALENDAR
| Application | From January 28th, 2013 to June 23rd, 2013 |
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| Selection | July 08th, 2013 |
| Registration | From July 15th, 2013 to September 16th, 2013 |
| Programme | From September 30th, 2013 to December 20th, 2013 |
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Online course period
Schedule for online meeting sessions, excercice deadline, and resource availability will be provided by the trainers' team
Assessment period
Details on the exam organisation are provided by the trainers' team
FEES & SAVINGS
Application fees
The Certificate application fees amount is 25.00 Euros.
These fees can be paid either by on-line payment or by post before the application deadline. These fees are not refundable.
Tuition fees
| Students | Professionals |
|---|---|
| 1,500 Euros | 3,000 Euros |
Savings
Eu2P rewards trainees attending Eu2P Certificates by granting Eu2P points. Once accumulated, these points can be used to lower tuition fees.
Students and professionals related to Eu2P partners can also claim some saving on Certificate tuition fees.
See Eu2P tuition fee savings for further details.
SELECTION BOARD
The Eu2P Domain Board selects the Certificate trainees.
This board assesses applicants's previous education, professional experience, and prerequisites' compliance.
See Eu2P acadmic governance for further details about the Eu2P Domain Boards.
| Title | Partner institution | Partner representative |
|---|---|---|
| Domain Director | University of Hertfordshire | Sherael Webley |
| Domain Codirector | GlaxoSmithKline Research and Development Ltd | Elisabeth Swain |
| Module Coordinator | University of Hertfordshire | Christopher Benham |
| Module Coordinator | University of Hertfordshire | Marika Vousden |
| Module Coordinator | University of Hertfordshire | Bharat Amlani |
OTHER PROGRAMME REGISTRATION
This module is also included in the Master Year 1
CONTACT INFORMATION
You can contact the Eu2P central office to get further information about:
- Candidate application, selection and enrolment
- Tuition fees, grants and savings
- Course calendar
- Research project placements and mobility
- Exams organisation
Send an online message to the Eu2P central office
COURSE CATALOGUE
BASICS FOR PHARMACOVIGILANCE AND PHARMACOEPIDEMIOLOGY
BENEFIT ASSESSMENT OF MEDICINES
MEDICINES PHARMACOVIGILANCE AND REGULATORY ASPECTS
MEDICINES RISK IDENTIFICATION AND QUANTIFICATION
MEDICINES BENEFIT-RISK ASSESSMENT
MEDICINES AND PUBLIC HEALTH
MEDICINES RISK COMMUNICATION
