Major Quality Systems Seminar Prescribes The 'Inside Track' To American Pharmaceutical Gmps & Approvals

Main Category: Pharma Industry / Biotech Industry
Article Date: 08 Oct 2008 - 4:00 PDT

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A major three-day seminar promises everyone involved in the manufacture and supply of pharmaceuticals to the US with an unrivalled opportunity to gain not only exclusive and authoritative insights into the latest Food & Drug Administration's current Good Manufacturing Practice (cGMPs), but also expert advice on the FDA's new product approval review process, the organisation and management of clinical trials, and on effective product marketing.

The three-day 'Pharmaceutical cGMPs and the Approval Process: a Quality Systems Approach' seminar being staged at the University of Cambridge Murray Edwards College on 9-11 December 2008 is being led by Dr Kaiser Aziz, former US FDA division director.

Dr Aziz 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.

His presentations in Cambridge therefore offer UK pharmaceutical professionals an exclusive 'inside track' into how to get 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 seminar will focus on how quality systems should evolve during the pre-market processes and, for example, on how critical control points for product improvement should be identified and implemented throughout the product lifecycle.

The comprehensive schedule of events embraces ten modules:

Day 1 - cGMP: Regulations, Compliance & Inspection

Module 1 - FDA and the FD & C Act - overviews of the FDA drug regulations

Module 2 - Regulatory perspectives on cGMP

Module 3 - CFR Part 210 cGMP in manufacturing, processing, packing or holding of drugs (general) - overview of Sections 210.1, 210.2 & 210.3 plus 21 CFR Part 211 cGMP for finished pharmaceuticals

Module 4 - FDA compliance and inspectional observations - guidance and review of FDA systems inspections.

Day 2 - Quality systems, Drug development, Regulatory practice and approach

Module 5 - Quality systems approach - ICH Q9, quality risk management including plan, analysis, evaluation and control as well as reporting, potential risk management, failure mode & effects analysis, fault tree analysis, post-production monitoring and future expectations

Module 6 - Drug development - human drugs, full new drug application (505 (b)(1)), Paper NDA (505(b)(2), patent extension, exclusively (new chemical entity, new clinical study, paediatric), generic drugs (505(j)), ANDAs

Module 7 - Regulatory practices and procedures of new drug development approvals - non-clinical drug development (pharmacology, drug metabolism and toxicology), investigational new drug application and the investigator's brochure, general considerations, and abbreviated and supplemental new drug applications.

Day 3 - Clinical research development, New drug applications and Clinical study design

Module 8 - Clinical research development - protocol development, adverse experiences and reactions, and interaction of drugs, biostatics, the role of industry and FDA liaison

Module 9 - Specific aspects of new drug applications - chemistry, manufacturing & control requirements of NDA and ANDA, data presentation for FDA pre-market applications, preparing for FDA inspections

Module 10 - Good clinical practice and management of the clinical study design - design & analytical approaches to clinical trials, responsibilities of the principal investigator, sponsor and monitor, institutional review board/independent ethics committee and informed consent, quality assurance, health insurance Portability & Accountability Act, pre-FDA studies, organising and managing the clinical trial, and interaction with the FDA.

Commenting, ARV Excellence director Eoin Barry who is co-hosting the seminar, says the event - the first of its kind in the UK - will also discuss biomarkers and nanoscale technology from regulatory perspectives, in addition to key aspects of clinical trial design, new drug applications and the approval process, so will impact everyone involved in the manufacturing and supply chain - from R & D through quality approval, pre-clinical and clinical research, regulatory affairs, marketing and management.

Visit http://www.arvexcellence.com for full details, including the 15 per cent discount available for bookings before 11 November 2008.

ARV Excellence