Abstract
Regulatory affairs professionals are expected to provide an overall assessment of product information in the following areas: (1) US and applicable foreign regulatory affairs; (2) preclinical information; (3) clinical information; (4) CMC and Supply Chain information; and (5) commercial information related to the actual product profile. The actual product profile includes weaknesses, in contrast to the package insert (or summary of product characteristics in the EU) which is, to some extent, a regulatory negotiated document and may not reflect all of the weak points associated with a particular drug, biologic, or device.
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Ballpark trial costs are usually provided by the potential partner, but can be verified/obtained from a qualified contract research organization. It is important to be aware of all trial costs, including costs attributed to the investigators.
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© 2012 Springer Science+Business Media New York
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Huml, R.A. (2012). The Regulatory Functional Review: Primary Roles. In: Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional. SpringerBriefs in Pharmaceutical Science & Drug Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3682-9_3
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DOI: https://doi.org/10.1007/978-1-4614-3682-9_3
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