Preparing for Regulatory Review and Reimbursement Decisions
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The process of drug discovery, development and regulation has been described as a series of incremental advancements punctuated by periodic, radically innovative paradigm shifts. Keystone advancements in this modern phase of medicines discovery have included the refinement of targeted combinatorial chemistry, the practical application of high-throughput screening technologies, advances in data mining and bioinformatics, and the use of proteomics and biomarkers from the earliest phases of discovery and throughout the development lifecycle.
Advances in standardizing regulatory requirements promulgated by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) have led to ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration with the objective of reducing or obviating the need to duplicate the testing carried out during the...
This article benefited from the review of Dr Mel Walker, GlaxoSmithKline. The authors also acknowledge the inclusion of concepts presented by Dr Eric Abadie, Committee for Medicinal Products for Human Use at the European Medicines Agency; Dr Hilary Malone, Wyeth Laboratories; Clare McGrath, Pfizer Laboratories; Professor Robert Peterson, University of British Columbia; and Dr Ad Shuurman, Medicine Evaluation Committee at the workshop entitled “Review and reimburse-ment: a special case for better co-operation” held 29–30 September 2009, Surrey, UK, and sponsored by the Institute (http://www.cmr.org
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