Joint MHRA / DIA Excellence in Pharmacovigilance (Feb, 2016)

This course is designed to provide a firm grounding in key aspects of Global and mainly European Clinical Pre- and Post-Marketing Safety regulatory requirements. This five-day training course now also includes highlights and updates on the pharmacovigilance legislation and the latest news on the international harmonisation and standardisation activities in pharmacovigilance.

What participants from previous course say:
"Thank you for a great and comprehensive course. It was great to hear the perspectives of the different speakers as well as to meet a number of people working within this sector"
"A well organised course in an excellent location. The course director should be commended!"
"A very interesting course with lots of takeaway reading to do. The meeting was very well organised and the day schedule was kept to plan"

Who Should Attend

Professionals involved in pharmacovigilance and namely Qualified Persons for Pharmacovigilance (EU QPPV), clinical research, regulatory affairs, risk management, medical product safety assessment, and data analysis, epidemiology, labelling, quality assurance, compliance, medical information.
Level: Intermediate

Learning Objectives
For the five key topics as outlined above, the learning objectives also include the ability to:

• Describe the expedited and periodic ICSRs reporting requirements in clinical trials and post-marketing including the medical evaluation
• Describe how to be prepared for audits and inspections in pharmacovigilance
• Understand the principles of signal management
• Describe the components of the risk management

Price:
Member Charitable Nonprofit/Academia/Government: EUR1660
Member Standard: EUR3285
Charitable Nonprofit/Academia/Government: EUR1815
Standard: EUR3475

Speakers: Gaby L. Danan, Phil Tregunno, Jerome Calmejane