Pharmacovigilance in Clinical Trials

Abstracts: The importance of Pharmacovigilance in drug safety is well established. The role of Pharmacovigilance has traditionally been focused on detection and evaluation of signals for new adverse drug reactions (ADRs) in the post-approval scenario in order to secure early detection and to introduce measures to manage those risks. However, there is also need to incorporate newer approaches for managing safety information in the clinical trial setting and to implement the methods and tools used in post-approval pharmacovigilance to the early and late stages of pre-market development of medicinal products.

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