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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, Prof Bruno Stricker, Dr Sandra De Bie, Marten Van Den Berg (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 Gianluca Trifiro (from Università degli studi di Messina), 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 will be available
from January 28th, 2019 to September 08th, 2019.
Thanks for applying during this period.

Contact the Eu2P Central Office

Applications will open on January 28th, 2019. 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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