Three days pharmacovigilance conference titled “Advanced Pharmacovigilance” will be held by the Management Forum Ltd in London, UK from September 25-27, 2017. 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.
Key topics to be covered in the conference include 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.
The conference will enhance attendees global safety knowledge, their team’s capabilities and compliance in both the regulations and their company’s expectations. It will help ensure them build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection. The event will provide invitees an opportunity to take part in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspection.