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UKConference

Signal Detection and Regulatory Expectations


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Who should attend?

This course will be of interest to those working in drug safety/pharmacovigilance as well as Regulatory personnel responsiblse for amending the labelling for products and for the production of the CCSI/DCSI.

Details

Course overview

Featuring signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitiive assessments.

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 quantitiive assessments.

Why you should attend

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.

Prices

GBP EUR USD Standard 1399 1959 2182 Early 1199 1679 1870 Excluding VAT @ 20.00% Book by 29 Sep to get the early booking price shown above

Contact

Leigh White
info@management-forum.co.uk

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