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ACADEMIC RECOGNITION OF 3 OR 6 CREDITS


DESIGNED FOR EXPERTS BY EXPERTS


PRINCIPLES OF IDENTIFYING AND RECOGNIZING ADVERSE EVENTS AND SAFETY SIGNALS


OBJECTIVES



To enable students to develop an understanding of current practice in identifying adverse drug reactions and safety signals

To be able to classify events, identify signals and understand the follow-up procedure

ADRs, AEs, causality, expedited reporting, PSURs, AE dictionaries, safety signal generation, risk management plan, pharmacovigilance plan

 

MODULE PARTS



  1. Definition of adverse drug reactions - type of ADRs
  2. Detection and recognition of adverse events in clinical trials
  3. Adverse event coding principles and differences
  4. Spontaneous reporting databases
  5. Principles of signal detection on electronic health care databases
  6. Risk management plans

 

TRAINER TEAM



Coordinator: Dr Katia Verhamme (from Erasmus Universitair Medisch Centrum)

Expert(s): Dr Martijn Schuemie, Dr Gianluca Trifiro, Dr Sandra De Bie (from Erasmus Universitair Medisch Centrum), Dr Patrice Verpillat (from Merck KGaA), Dirk Teuwen, Dr Peter Verdru (from UCB Pharma SA), Dr Barbara Donner, Dr Fraser Mccallum, Dr James Stevens (from F. Hoffmann-La Roche Ltd), Dr Laurent Auclert, Dr Juhaeri Juhaeri (from Sanofi-aventis Recherche et Développement), Dr Sebastian Monzon (from European Medicines Agency), Dr Ugo Moretti (from Università di Verona), Dr Sabine Straus, Dr Fakhredin Sayed Tabatabaei (from Dutch Medicines evaluation Board), Dr Paul Avillach (from Harvard Medical School).

Intermediate level
75 h workload over 3 months (3 ECTS credits)
Key dates
Course calendar
Certificate award
or included in Master Year 2 or PhD programme
English language
Online based learning
Student: 1,500 €
Professional: 3,000 €
  Savings could be offered under eligibility conditions.

Applications currently closed

Application to this training closed on September 08th, 2017.
You will be able to apply to the next training session
from January 29th, 2018 to September 09th, 2018.

Contact the Eu2P Central Office

Next session application will start on January 29th, 2018.
Please contact the Eu2P Central Office for information.

Or include this module in your training curriculum choices...

Master Year 2 PhD



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