Seminar Operational 4: Challenges in vigilance

Session: 
Thursday, 14 March 2013 - 3:00pm to 4:30pmFriday, 15 March 2013 - 9:00am to 10:30am

Room: 

352 A+B

Facilitator: 

Stemer, Gunar

Presenter: 

Vandevelde, Florence
van Grootheest, Kees

 

Abstract:

All activities in the special fields of vigilance (e.g. pharmacovigilance, hemovigilance, medical devices’ vigilance) contribute to the protection of patients’ and public health. With the focus on drugs, pharmacovigilance objectives aim at harm prevention from adverse reactions in humans arising from the use of authorised medicinal products and at promotion of their safe and effective use. Nevertheless incidents (e.g. the Mediator® scandal in France) lead to considerable unease for patients and to the call for stronger observation and control.

2012 has seen the implementation of  new EU pharmacovigilance legislation and the implementation of good pharmacovigilance practice (GVP) has started and is ongoing. The first part of the seminar will highlight on key aspects of the new pharmacovigilance legislation and describe the concept of GVP insofar as the hospital pharmacist is concerned.

The hospital pharmacist plays a central role in reporting adverse drug reactions to competent authorities. However, what other areas are covered? The second part of the seminar will critically discuss limitations of the new pharmacovigilance legislation and outline further roles for hospital pharmacists (e.g. pharmacotherapy safety) and opportunities for advancement in this field.

Teaching Goals:

  • to outline and critically discuss the main aspects of the new pharmacovigilance legislation being relevant to hospital pharmacists
  • to describe the concept of good pharmacovigilance practice and critically discuss the parts especially relevant to hospital pharmacists
  • to illustrate roles, challenges and opportunities for hospital pharmacists in pharmacovigilance

Learning Objectives:

After the presentation the participant should:

  • be able to summarise the most relevant aspect of the new pharmacovigilance legislation and describe principles of good pharmacovigilance practice (GVP)
  • be able to describe major tasks of hospital pharmacists’ in pharmacovigilance
     

•        be able to summarise the most relevant aspect of the new pharmacovigilance legislation and describe principles of good pharmacovigilance practice (GVP)
•be able to describe major tasks of hospital pharmacists’ in pharmacovigilance