SUBSTANTIATION AND QUANTIFICATION OF RISKS
MODULE OVERVIEW
| Objectives | To enable students to design studies, write protocols To quantify and analyse safety signals or risks To understand the potential and limitations of post marketing hypothesis testing studies |
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| Topics |
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| Keywords | ADRs, AEs, causality, observational databases, study design, confounding, meta-analysis, bayesian methods |
| Level | Intermediate |
| Trainers' team | Prof. Nicholas Moore (from Université Bordeaux Segalen), Dr Preciosa Coloma [module coordinator], Prof. Miriam Sturkenboom, Dr Martijn Schuemie, Ms Ingrid Leal, Dr Peter Rijnbeek, Dr Gianluca Trifiro, Dr Jeanne Dieleman, Dr Silvana Romio (from Erasmus Universitair Medisch Centrum), Nadia Foskett, Jamie Robinson, Dr George Quartey, Dr Philippe van der Auwera, Dr Hans Petri, Dr Bharat Thakrar (from F. Hoffmann-La Roche Ltd), Dirk Teuwen (from UCB Pharma SA) and Dr Sabine Straus (from Dutch Medicines evaluation Board) |
| Workload | 6 ECTS credits |
| Training mode | e-learning |
| Language | English |
| Eu2P training affiliation |
Certificate in Medicines risk identification and quantification Master Year 2 |
CERTIFICATE PROGRAMME REGISTRATION
PROFILE & PREREQUISITES
- Educational prerequisite for this module certificate programme:
Postgraduate degree or working experience in clinical, scientific, statistical or epidemiological studies
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 April 08th, 2013 to October 27th, 2013 |
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| Selection | November 04th, 2013 |
| Registration | From November 11th, 2013 to December 16th, 2013 |
| Programme | From January 06th, 2014 to June 20th, 2014 |
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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 |
|---|---|
| 2,500 Euros | 5,000 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 | Erasmus Universitair Medisch Centrum | Miriam Sturkenboom |
| Domain Codirector | H. Lundbeck A/S | Patrice Verpillat |
| Module Coordinator | Erasmus Universitair Medisch Centrum | Katia Verhamme |
| Module Coordinator | Erasmus Universitair Medisch Centrum | Preciosa Coloma |
| Module Coordinator | Erasmus Universitair Medisch Centrum | Bruno Stricker |
OTHER PROGRAMME REGISTRATION
This module is also included in the Master Year 2
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
