Event Date: 02/12/2011 01:00
The Irish Medicines Board will hold a Human Medicines Pharmacovigilance Information Day on Friday 2nd December 2011 in the Crowne Plaza hotel, Santry. The meeting will specifically address the implementation of the new European Pharmacovigilance legislation.
The agenda for the event is now available. Please find a link to the agenda below:
A copy of the presentations are available below:
1. New pharmacovigilance legislation to promote and protect public health
2. Implementing the New Pharmacovigilance Legislation - Almath Spooner
3. Requirements for systems for the performance of Pharmacovigilance activities by MAH - Sinead Curran and Majella Quinn
4. Changes to adverse reaction reporting requirements - Niamh Arthur
5. Signal detection activities including Direct Patient Reporting - Mick Foy
6. National Transposition of New EU Pharmacovigilance Legislation - Marita Kinsella
7. Benefit-risk evaluation and Pharmacovigilance planning - Almath Spooner
8. Format and content of the protocol, abstract and study report - Yvonne Buggy
9. Risk minimisation and educational material - Eleanor Carey
10. Key concepts on communication and transparency - Caitriona Fisher
11. Information to patients, risk communication and transparency - Francois Houyez
Aims of the Seminar
The information day will address topics on: Good Vigilance Practice, quality system for the performance of pharmacovigilance activities, changes to adverse reaction reporting requirements, signal detection and signal management, periodic safety update reports (PSURs), risk management plans (RMPs), post authorisation safety studies (PASS), risk minimization, educational materials, communication and information to patients.
Colleagues from European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA) and European Organisation for Rare Diseases (EURORDIS) will make presentations at the meeting.