Having extensivly used MedDRA in the production environment since 1997, the instructors at PSI are uniquely qualified to provide a training curriculum which meets your organization's needs. So far, the PSI team has coded/classified over 1.8 million individual case safety reports (ICSRs) for the FDA, and over 8 million verbatims for the pharmaceutical industry; we have trained over 4,000 students on 4 continents. Our instructors share the insight and specific knowledge obtained through concrete experience in both pre- and post-marketing environment. Our participants do not need to reinvent the wheel - the MedDRA knowledge which we impart will enable them to implement and utilize MedDRA in the most efficient and cost-effective manner.
Our courses are offered throughout the year at selected locations. Please check our Training/Presentations Page for the most up to date information regarding the training schedule.
On-site training is also available. There are three major advantages to on-site training. First, the participants will be using MedDRA in the real environment and using the tools they would actually employ. Secondly, our instructors could customize the training program to meet the individual organization's specific needs and philosophies. Finally, this would minimize downtime and travel expenses.
A common question is, "Who should be trained?" Anyone who will have to deal with MedDRA be it directly or indirectly will need to have a good understanding of MedDRA. This would include:
• Clinical data managers
• Clinical safety monitors / Post-Marketing Safety Monitors
• IT professionals
• Regulatory Affairs professionals
Because different professionals require different perspectives on MedDRA, we offer a variety of courses to suit an individual's need. Please refer to the Current Course Offerings for a list of available courses and their outlines to determine which course would best suit your needs.