Information Day – Good Clinical Practice for Investigational Medicinal Product Trials – Agenda now available

Event Date: 23/10/2018

The HPRA are delighted to announce that registration for a compliance information day on Good Clinical Practice (GCP) for Investigational Medicinal Product (IMP) trials is now open.

The event will be held in Dublin on Tuesday 23 October 2018 in the Camden Court Hotel on Camden Street, Dublin 2

The information day is being hosted to provide up-to-date information on evolving legislation and guidance, to provide an overview of the HPRA GCP inspection program including common findings, and to clarify expectations for compliance across key areas.

The programme will include presentations relevant to both investigator site and sponsor compliance, with a focus on trials run in the non-commercial setting.

Topics include:

• A review of relevant legislation and guidance, including recent and future changes
• The HPRA GCP inspection program and common findings
• Expectations for GCP compliance at investigator sites in key areas including protocol compliance and data integrity
• A series of presentations on clinical trial sponsorship, with a focus on non-commercial organisations

The agenda has now been published and is available for download 
Good Clinical Practice for Investigational Medicinal Product Trials - Agenda

Who Should Attend

Those undertaking the role of non-commercial sponsor for the first time, or considering expanding their level of activity in this area, are in particular encouraged to attend. The information day will also include presentations relevant to investigator site staff and to commercial sponsors, in particular monitoring and quality personnel.

Due to room capacity, it may be necessary to limit the maximum number of attendees from any one individual organisation. In the event that this is necessary, you will be contacted and your registration fee returned.

Register for this event