OVERVIEW
Advanced Pharmacovigilance Course is organized by Management Forum (Mf) Ltd and will be held during Mar 07 - 09, 2018 at The Rembrandt Hotel, London, England, United Kingdom.
The target audience for this medical event is the safety professionals who are working both in the Clinical and Post-Marketing Safety arena including QA for auditing. The course covers very diverse activities within the Safety Department and would be advantageous to those who have either multifunction responsibilities or Medical Directors who manage teams in the various disciplines.
Conference Description :
This course is designed for those with at least two years worth of knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company pharmacovigilance Inspection.
Conference Topics :
• Training for Drug Safety Reporting Duties, Audits and Expectations Risk Based Inspections
• The DDPS retirement and the New PV Master file in the EU
• Compliance and Drug Safety
• Product Safety Reviews Purpose and Function (incorporating the new EU Signal Analysis Requirements)
• Developing Company Core System Information CIOMS III
• Safety Reporting in Licensing Agreements
• PSURs Timing, Content and the DSUR and the New ICH E2C (2nd Revision requirements)
• Implications for Safety Reporting in Global Clinical Trials
• Risk/Benefit Determinations
• Risk Management Plans
Fee Details :
Conference Fee : € 3106.80
Multiple booking discount for 2nd or subsequent delegates Fee : € 2640.78
Conference Fee : USD 2,884
Additional details will be posted as soon as they are available.
KEY DATES
07 Mar, 2018
Event Start Date
09 Mar, 2018
Event End Date
SPECIALITIES
Clinical PharmacologyResearch and Clinical ResearchQuality ManagementSUGGESTED HOTELS
CONFERENCE VENUE
The Rembrandt Hotel 11 Thurloe Place