Medical Writing between Dossier Submission and Drug Approval

While the Common Technical Document harmonises the structure of regulatory documents submitted to the European CHMP 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 writing required for the post-submission review processes of these two authorities. We will draw on our personal experiences of working together for over four years in the post-submission phase of a drug development programme, to illustrate the pivotal role medical writers can play in helping to optimise a sponsor's chances for obtaining a successful drug approval.


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