Ensuring safety and efficacy of pharmaceuticals and biotechnology products is one of the top challenges in the healthcare industry today. Drug withdrawals have further heightened the focus on drug safety with consumers and other stakeholders across the healthcare ecosystem demanding more oversight. Regulators across the globe are responding to these pressures by increasing their scrutiny and compliance requirements from the industry. Post-launch product withdrawals pose numerous risks to patient safety, besides being detrimental to business in terms of loss of revenue and credibility. A robust safety management approach during clinical development would help detect safety issues earlier in the product lifecycle and avoid subsequent debacles.
Safety monitoring in clinical trials is integral to the conduct of clinical research to ensure both patient safety and integrity of study data. Clinical trial safety management involves: collection, assessment and submission of expedited reports of serious, unexpected, suspected adverse reactions (SUSARs) to the regulators and all other stakeholders (investigators, ethics committees and Data and Safety Monitoring Board (DSMB)) in a timely manner; collection and periodic analysis of all safety data, including non-serious adverse events and laboratory data of trial patients; preparation and submission of annual safety update reports (Developmental Safety Update Reports in the EU, Investigation New Drug (IND) Annual reports in the US); signal detection and risk management activities, including preparation of risk management plans etc.
The activities are mandatory and requirements are numerous and varied.
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