GET A VALUABLE CERTIFICATE FOR JOB MARKET


ACADEMIC RECOGNITION OF 3 OR 6 CREDITS


DESIGNED FOR EXPERTS BY EXPERTS


PRINCIPLES OF IDENTIFYING AND RECOGNIZING ADVERSE EVENTS AND SAFETY SIGNALS


Eu2P Certificate: Principles of identifying and recognizing adverse events and safety signals

OBJECTIVES

To enable you 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 (from Janssen Pharmaceutica NV), 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), Prof Bruno Stricker, Dr Sandra De Bie, Victor Pera (from Erasmus Universitair Medisch Centrum), 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), Dr Fariba Ahmadizar (from University Medical Center Utrecht).

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.

APPLY NOW

Applications open until September 08th, 2024

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

Master Year 2 PhD



Confused? Read the FAQs...

NEED TO TALK TO US?

+33 5 47 30 42 69

Monday-Friday / 9.00am-6.00pm CET

 

Powered By

Eu2P Executive Board partners

Created By

Eu2P project consortium partners