Building quality into regulatory dossiers and the review process: Knowing and meeting customer expectations
2nd-3rd December 2004, Woodlands Park Hotel, Surrey, UK
Overview
This was the fourth Workshop organised in 2004 by the CMR Institute for Regulatory Science and rounded-off earlier discussions with an in-depth look at ‘Quality’ as it applies to compiling a regulatory submission and carrying out regulatory reviews.
At the Institute Workshops in May 2004 (global drug development) and October 2004 (benchmarking the regulatory review process), many references were made to the relationship between the quality of regulatory dossiers and successful review outcomes. This Workshop developed the subject further.
Built-in Quality
The Syndicate discussions, that are a regular feature of Institute Workshops, looked at proposals for studying the ways of building quality assurance into agencies’ and companies’ procedures. In the case of the regulatory agencies, the Syndicates made recommendations on proposals for a specific study on the current stat us and implementation of quality measures. For companies, the Syndicates made preliminary recommendations on the key elements for defining a ‘quality’ dossier and for monitoring the quality of submissions both during preparation and retrospectively.
Scorecard Proposals
The Benchmarking workshop (October 2004) had arrived at specific recommendations for a ‘Scorecard’ system to facilitate feedback, at the end of a review, on the quality of the dossier and the way in which the review had been conducted. These proposals were developed further in the workshop on Quality with a proposal for a pilot study that will be considered by the Institute’s Advisory Board, for inclusion in the work plan for 2005/2006.
Under this pilot study, two report forms would be drawn up and tested by participating authorities and companies:
- Scorecard on the industry: for the reviewers to report their impressions of the quality of the dossier following the review of a new drug application
- Scorecard on the agency: for the company to report back on key aspects of the review process and their interaction with the authority during the review.
Synopsis of the Workshop Programme
The first two Sessions were chaired by Thomas Lönngren, EMEA Executive Director. Session 1 looked at ‘Building quality into the application dossier’ and Dr David Lyons , Irish Medicines Board, discussed his experience of the strengths and weaknesses of applications, contrasting ‘avoidable’ and the ‘unavoidable’ problems. Industry presentations by Dr Paul Huckle, GlaxoSmithKline, and Dr Susan Forda, Eli Lilly, looked at ways companies can implement quality management systems within regulatory affairs departments and the importance of analysing past experience in order to learn lessons from application history.
In Session 2 the focus was on ‘Building quality into the regulatory review process’. Dr Marijke Korteweg, EMEA, described a major EU project to implement good regulatory review practices among accession states prior to the recent expansion of the EU. Prof. Rolf Bass, BfArM, Germany, then provided further experience from the twinning project between Germany and Poland. An industry viewpoint was provided by Dr Ron Garutti, Schering-Plough, who looked at companies’ expectations for scientific integrity, communication, transparency and consistency in review processes.
Session 3, chaired by Prof. Stuart Walker, CMR International, looked towards future developments. Dr Osamu Doi, Senior Executive Director, PMDA, Japan, reported on the reforms and performance goals that are being implemented by the new Japanese agency. The regulatory implications of technological developments were discussed by Dr David Jefferys , UK Department of Health, especially against the background of the changing healthcare delivery environment. An industry vision for the future was presented by Moira Daniels , AstraZeneca, with a focus on earlier availability of new therapies to patients along with continual benefit- risk monitoring.
Finally, Prof. Larry Phillips, London School of Economics, gave a thought-provoking presentation on the philosophy, principles and practice of building quality into decision-making processes and how these apply in the pharmaceutical environment.