Get The 'Inside Track' To US Pharmaceutical CGMPS & Approvals - Seminar, Cambridge, England

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Conferences
Article Date: 23 Oct 2008 - 10:00 PDT

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For pharmaceutical professionals who need to keep up to date with the US Food & Drug Administration's role in drug development, the requirements of IND/NDA, and clinical trial structure and design, for example, next month's 'Pharmaceutical cGMPs and the Approval Process: a Quality Systems Approach' seminar in Cambridge is an event they cannot afford to ignore.

Being staged at the University of Cambridge Murray Edwards College on 9-11 December, the seminar also promises to update delegates on:

-- The logic of the drug development process;
-- The post-approval responsibilities of sponsors;
-- Good Laboratory Practice (GLP);
-- Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP); and
-- The FDA review of an IND/NDA.

In addition, delegates will also be provided with an invaluable insight into the quality systems approach as it applies to drugs and the event will present future regulatory direction being taken by the FDA - in short, the inside track to getting products to the US market more efficiently and with less risk.

Organised by ARV Excellence - the specialist provider of training and consultancy to the pharmaceutical, life sciences and medical device sectors - the three-day event is being led by former US FDA division director Dr Kaiser Aziz, who has a distinguished career as a clinical regulatory scientist and manager of drug and device evaluations, approvals, re-engineering, standards, good manufacturing and quality system applications - which includes 29 years with FDA.

The comprehensive schedule embraces ten modules under the themes of 'cGMP: Regulations, Compliance & Inspection', 'Quality systems, Drug development, Regulatory practice and approach', and 'Clinical research development, New drug applications and Clinical study design'.

According to ARV Excellence director Eoin Barry, who is co-hosting the seminar, the event is being well-received by the pharmaceutical supply chain - from R & D through quality approval, pre-clinical and clinical research, regulatory affairs, marketing and management - "which is no real surprise since substantial discounts are available for bookings before 11 November 2008," he says.

Visit http://www.arvexcellence.com for full details of the comprehensive programme and booking information.

ARV Excellence