Dato:
17. april 2012 - 19. april 2012

Formål:
What you learn
This course aims to provide you with basic knowledge of the elements in Safety and Pharmacovigilance in post-marketing surveillance and within Clinical Trial. In keeping with the rules and regulations on Pharmacovigilance, you will receive an exhaustive introduction to essential terminology and information sources as well as a thorough introduction to why and how clinical trials are performed.

Indhold:
Content
The course will break down complex topics such as:
• National and international initiatives in pharmacovigilance: Perspectives of the Danish Medicines Agency
• Danish and European drug safety regulations
• The individual case report: How to identify and prepare expedited case reports
• Electronic submission and MedDRA coding principles
• Clinical Trial Directive 2001/20EC (incl. EC Guidance)
• Non-interventional Trials
• Risk Management Plans
• Risk Management: A crisis in a PV department
In conclusion, the course examines; Regulatory reports as PSUR, and DSUR. Product Safety Information and Signal Detection. Interfaces with Regulatory department and with Quality assurance with regards to Pharmacovigilance Audits and Inspections, and how to prepare.

Målgruppe:
Target
The course is aimed at newly hired employees with up to six months of employment and at employees in subsidiaries, who wish to obtain a general understanding of safety and pharmacovigilance.
The course can also be of relevance for pharmacovigilance employees collaborating with clinical development employees on adverse event reporting in connection with clinical trials.
Pharmacovigilance employees in need of introductory information on risk management plans, crisis management in pharmacovigilance departments and audits and inspections will also benefit from this course.

Forudsætninger:
Language
The course is taught in English, unless all students are Danish.