Preparing Investigator Sites and Research & Development Departments for GCP Inspections (UK)

Registration is now open for the following courses:

• July 15, London — Register
• October 21, London — Register
• November 18, Manchester — Register

Course Description
This course is for all non-commercial sector professionals working on trials subject to GCP inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).  This one-day introductory/intermediate level course is offered in two parts. The morning session concentrates on organisational issues arising within R&D department and therefore all categories of R&D staff are strongly recommended to attend. The afternoon session concentrates on issues specific to investigator sites and all members of the site staff as well as pharmacists and lab staff will find this of benefit. R&D staff should attend the full day as they will need to help and advise site staff prepare for inspections.

Learning Objectives
Upon successful completion of this course, participants should be able to:

• Explain the objectives of GCP inspections and what inspectors’ will review
• Develop an action plan to prepare for Inspection
• Identify and use at least 3 positive approaches for interviews during inspections
• State 6 common inspection findings in relation to systems, Investigational Medicinal Product management, and training
• Formulate corrective actions and preventative actions

Agenda
Download Agenda (.pdf)

Cost
Full day — £285 per person
Afternoon session - £165 per person
Note: R&D staff are expected to attend the whole day and Investigator site staff will attend in the afternoon and join the R&D staff who  
should be remaining from the morning session. i.e. R&D staff are expected to attend the whole day. Attending morning only will not be an option

Contact
If are you interested in hosting the event to save travel and accommodation costs please contact siobhan@acrpnet.org for further details.
For further information on the course and to provisionally reserve a place on future training dates when they are released please contact:

Siobhan Lim, RN, BSc, CCRC, CCRT
Manager Clinical Research Training, ACRP
European Office, Windsor
Email: siobhan@acrpnet.org
Tel: 00 44 1753 831 908