The Ultimate Resource for Pharmaceutical SOPs and Best Practices
The purpose of this SOP is to outline the procedures for ensuring the privacy and confidentiality of data collected and processed during pharmacovigilance activities, in compliance with regulatory requirements and company policies.
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The purpose of this SOP is to outline the procedures for defining, collecting, analyzing, and reporting pharmacovigilance metrics and key performance indicators (KPIs) to ensure the effectiveness and efficiency of pharmacovigilance activities.
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The purpose of this SOP is to outline the procedures for conducting pharmacovigilance compliance training to ensure that all personnel involved in pharmacovigilance activities are adequately trained and compliant with regulatory requirements and company policies.
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The purpose of this SOP is to outline the procedures for conducting a scientific literature review to identify relevant safety information related to pharmaceutical products and ensure compliance with pharmacovigilance requirements.
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The purpose of this SOP is to outline the procedures for the formation and functioning of the Risk Assessment Team (RAT) within the pharmacovigilance department, ensuring systematic evaluation and management of risks associated with pharmaceutical products.
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The purpose of this SOP is to establish procedures for managing crises related to pharmacovigilance activities, ensuring timely and effective response to adverse events or safety signals that may pose significant risks to public health.
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The purpose of this SOP is to outline the procedures for the withdrawal of pharmaceutical products from the market due to safety concerns identified through pharmacovigilance activities.
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The purpose of this SOP is to establish procedures for the recall of pharmaceutical products from the market in response to pharmacovigilance data indicating potential safety risks.
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The purpose of this SOP is to establish procedures for the preparation, submission, and management of pharmacovigilance regulatory submissions to regulatory authorities.
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The purpose of this SOP is to outline procedures for the timely and accurate reporting of pharmacovigilance data to regulatory authorities in compliance with regulatory requirements.
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