The Role of HTML
- PDF / 181,537 Bytes
- 3 Pages / 504 x 719.759 pts Page_size
- 14 Downloads / 207 Views
Drug Information Journal, Vol. 34, pp. 117-1 19, 2000 Printed in the USA. All rights reserved.
Copyright 0 2000 Drug Information Association Inc.
THE ROLE OF HTML GRAHAMSHELVEY Manager, Regulatory Logistics
ALAINPARMENTIER lnformation Technology Project Manager SynthClabo, Chilly Mazarin, France
The paper was originally presented in the context of an intemtional workshop dedicated to the electronic submission of marketing authorizations. It is to be kept in mind that the role of Hypertext Mark-up Language (HTML) is not limited to this sole endpoint but that the authors feel that this language is well adapted, today, to provide most of the key
functionalities required by electronic submissions. Key Words: Electronic submissions; HTML
THE KEY CONCERNS OF both industry and health authorities are, in fact, very similar. On the one hand industry builds, over sometimes considerable time periods, a submission. On the other hand, the health authority dismantles the submission into its basic components for review and future use. To achieve these ends a certain number of very basic features are required. Information on the completeness of the submission, and the ability to retrieve information from within the emerging dossier, so as to enable the production of the expert reports, summaries and that all-embracing Summary of Product Characteristics are of considerable interest and of real value to the company. When seen from the reviewer’s perspective, many of the above factors remain highly relevant. The re-use of information contained in a submission, the ability to compare submissions of like products, and the capacity to store different parts of the submission in different databases for further
Reprint address: Graham Shelvey, Manager, Regulatory Logistics, Synthelabo, 91385 Chilly-Mazarin, France.
use are often cited as key factors in the review process. Again we must not forget our objective, to facilitate the submission of a marketing authorization by virtue of “modern electronic technology.” The much acclaimed usefulness of some file formats for submission archiving, while not to be forgotten, should not detract from this primary objective. Industry and reviewer needs with respect to electronic submissions can be summed up in three key words: Communication, navigation, and transparency. Communication is necessary because we both need to have a clear picture as to when the dossier is complete in order to start the review process as early as possible. We also need to be able to dispatch all or part of these large volumes of information in a secure, rapid, and easy to use environment. Navigation is probably the most attractive function today. The ever-increasing size of submissions coupled with the reduced timelines to evaluate the information no longer allow us the immense pleasure of calling in the heavy brigade to undo the remaining 70 boxes to see where the pharmacology mechanism of action data are! Finding our way
117
Downloaded from dij.sagepub.com at UNIV OF NEW ORLEANS on June 2, 2015
118
Graham Shelv
Data Loading...
