Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing 2017

Joint MHRA/DIA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing is organized by Drug Information Association Europe, Middle East and Africa (DIA EMEA) and would be held during Oct 02 - 06, 2017 at The Crystal, London, England, United Kingdom.

This Joint MHRA/DIA training 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.

For the five key topics as outlined below, 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

Key Topics :
• Definitions and Methods in Pharmacovigilance
• Regulatory Aspects in Pharmacovigilance and Practical Examples
• Diagnosis of Adverse Drug Reactions
• Signal Detection and Signal Management
- Modern Technologies and Social Media
• Risk Management

Who Will Attend :
This course will benefit professionals with minimum 1-2 year experience in Pharmacovigilance or adjacent functions, for example, PV Officers, PV Specialists, PV Experts, PV Coordinators,
Heads/Directors/Managers of Regulatory Compliance, Quality or Safety departments.
Level: Intermediate

Price :
Member Industry: EUR 3320
Non-member Industry: EUR 3475
Member Academia/Charitable/Government/Non-profit (Full-time): EUR 1660
Non-member Academia/Charitable/Government/Non-profit (Full-time): EUR 1815

Speakers :
Gaby L. Danan (Pharmacovigilance Expert, France), Phil Tregunno (Signal Management Unit Manager, MHRA, UK)