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Abstract

Recent regulatory initiatives and consensus documents have altered the conventional approach to evaluating and communicating pharmacovigilance information. While these trends may initially seem to provide opportunities to combine certain aspects of the premarketing and postmarketing safety evaluation functions, they also have the potential to obscure the substantial differences between comprehensive risk assessment in investigational and postmarketing settings. Personnel involved in evaluation of safety data from clinical trials (including studies for new indications for currently marketed products) must give special consideration to those regulatory, legal, scientific, and ethical issues that are unique to the premarketing environment. In this paper, we approach this complex topic by contrasting the risk assessment of investigational products, as summarized in the investigator's brochure, with similar, well-described risk evaluation processes that are carried out for marketed products.

Keywords

Adverse events Signaling Premarketing surveillance Investigator's brochure Informed consent

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A Review and Analysis of Key Regulations and Guidelines concerning the Safety Sections of the Investigator's Brochure

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