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Medical Writing Between Dossier Submission and Drug Approval

Level:
Advanced
Area:
Drug Development
Code:
DDA2b
Duration:
03:30:00
Workshop profile:
Medical writers with knowledge of MAA or NDA preparation who are interested in expanding their knowledge of authority review processes and the role of medical writing after dossier submission in Europe and the US.
Objective:
While the Common Technical Document harmonises the structure of regulatory documents submitted to the European EMA and the US FDA for marketing approval, the review processes leading to the decision on whether to approve or not still differ markedly between the two authorities. In both cases, though, the demand for medical writing skills in the broadest sense (linguistic, scientific, organisational, diplomatic) can be high. The objective of this workshop is to familiarise participants with the post–submission review processes of these two authorities and illustrate the pivotal role medical writers can play in helping to optimise a sponsor’s chances for obtaining a successful drug approval.
Content:
The workshop will navigate you through the post–submission review processes you can expect to encounter, and through the numerous medical writing activities that can arise during EMA and FDA reviews of a submission dossier (e.g., drafting responses to the authority’s questions, preparing safety updates and NDA amendments, writing briefing documents, organising and preparing presentation materials for CHMP Oral Explanations and FDA Advisory Committee meetings). The workshop illustrates salient points and potential pitfalls by recalling personal experiences working on a European–US approval team. The workshop exercise focuses on how FDA and sponsor can differ in their interpretations of the same data, which will give participants some insight into the FDA Advisory Committee hearing process and into the preparations that need to be made for it by the sponsor.