ICORG has further developed its drug safety efforts in the launch of its Pharmacovigilance Unit on 1st May 2007.

At a time when drug safety concerns have become increasingly important in public health and modern clinical practice, the Pharmacovigilance Unit is designed to evaluate the ongoing safety of investigational drugs and also provide notification to all concerned members of any findings that could adversely affect the health of patients enrolled on ICORG studies. In accordance with the EU Directive 2001/20/EC and ICH-GCP guidelines the Pharmacovigilance Unit will continue to develop in response to the needs of members.

ICORG’s role as sponsor has led to the increased service options now provided to members.

Examples of areas this unit will cover:

• Assessing compliance with national and EU Legislative requirements for the conduct of clinical trials to help you meet your regulatory obligations
• Draft and submission of Annual Safety Reports and line-listings to competent authorities in compliance with your organisation’s procedures.
• ICORG in-house reporting templates-SAE forms, Pregnancy reporting forms
• Pharmacovigilance agreements in licensing situations
• Receipt, verification and follow-up reports from sites of adverse reactions/events connected with study/IMP and feedback information to case reporters for both investigator led studies and studies conducted by institutions
• Reporting to the competent authority and Ethics Committee of the concerned member states all suspected unexpected serious adverse events.
• Electronic reporting of SUSARs onto EudraVigilance database as required by EU Directive 2001/20/EC
• Medical Review performed by appointed Principal Investigator or by a member of a review group and submission to Data Safety Monitoring Board
• Ongoing support to site based staff
• Advise on improvements in SOP development 
• Site monitoring to ensure patient safety protocol compliance

• The ongoing safety evaluation of the investigational medicinal product.

Where possible the Pharmacovigilance unit seeks to improve clinical trial safety surveillance and encourage a more pro-active approach to signal detection and risk assessment. We believe this is the future direction for drug safety.

If you have any questions in regards to safety reporting please contact our Pharmacovigilance Manager Mary Stapleton at mary.stapleton@icorg.ie or Pharmacovigilance Associate Sandra Boldrin at sandra.boldrin@icorg.ie