Explain the rationale behind the fda and ema requirement

Reference no: EM133406560

Question: Explain the rationale behind the FDA and EMA's requirement for expedited reporting of certain adverse events and how this requirement fits into the broader framework of pharmacovigilance. Be sure to clearly describe which specific type of event must be reported in an expedited fashion and include a description of pre- and post-approval expedited reporting, including timeframes for reporting. Describe the circumstances that trigger the need for expedited reporting, including examples of serious adverse events and unexpected safety issues. Discuss the potential benefits and challenges of expedited reporting and provide examples of this potential challenges.

Reference no: EM133406560

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