Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing

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

"The course was well organized, with active sessions leading to open discussions. The teachers were creating an environment that was facilitating the open confrontation and providing examples in order to facilitate the comprehension."
Ilaria Giunzioni, Drug Safety Manager, Grunenthal

"I think with this course you learn a lot and is very useful for a person who is working in pharmacovigilance."
Itziar López-Oleaga, Pharmacovigilance Technician, PHARMAMAR

• Definitions and Methods in Pharmacovigilance
• Regulatory Aspects in Pharmacovigilance and Practial Examples
• Diagnosis of Adverse Drug Reactions
• Signal Detection and Signal Management
• Modern Technologies and Social Media
• Risk Management

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

Level: Intermediate

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
• Understand the process of audits and inspections in pharmacovigilance
• Understand the principles of signal management
• Describe the components of the risk management