This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement
23-24 May 2019
& 25-26 Nov 2019
Increasingly the most common critical findings in Regulatory Inspections are being given for signal detection and management – so the need to identify potential signals and risks in patients has never been greater. The protection of patients through robust and clear methodologies for signal detection amidst the ever increasing regulations requires that Companies need to have trained and competent staff to perform such activities. This course will provide a detailed overview of all aspects of safety reviews and signal detection within a Company and will cover signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitative assessments.
This course will be of interest to those working in drug safety/pharmacovigilance as well as Regulatory personnel responsible for amending the labelling for products and for the production of the CCSI/DCSI.
An introduction to safety signals
Causality and signal detection
Generic and innovator products
The safety review meeting and process
Safety assessments life cycle
Safety assessments life cycle continued
The regulatory requirements for signal detection – Module IX
The signal review cycle
Quantitative and qualitative signal detection
Signals and their discussion
Quantitative signal analysis
EVDAS and the EU
Risk benefit analysis
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.