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Serving Two Masters: Comparing and Contrasting US and EU Regulatory Submissions and Processes

Workshop profile:
This workshop is intended for medical writers who wish to learn more about the global regulatory environment for pharmaceuticals.
The purpose of this workshop is to introduce medical writers to the regulatory and cultural underpinnings of differing processes applied to the preparation, submission, review, and approval of regulatory submissions for pharmaceuticals to EU and US licensing authorities. On completion of the workshop, attendees should better understand the way the agencies operate and the requirements (as stated in the regulations and implicit in industry best practices) for preparing a successful dossier.
There is an internationally agreed format for the presentation of an application dossier for a marketing authorisation for a pharmaceutical product: the Common Technical Document (CTD). It is accepted by all ICH member countries; however, this does not mean that the way in which reviewers approach the assessment is the same, or that the processes for submission, review, and approval are identical. In particular, there are significant differences between the way data are summarised and the approach taken by European reviewers compared to that taken by their counterparts in the USA. In addition, the Sponsor-Regulator interfaces and processes are quite different. While some of these differences may ultimately evolve to a state of commonality, others likely never will. Participants will be introduced to the origins of drug regulations, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and the USA will be explored. This workshop does not cover the regulatory requirements for medical devices or vaccines.