SOPs for Pharmacovigilance

The purpose of this SOP is to outline procedures for the monitoring, evaluation, and reporting of safety data during clinical trials to ensure participant safety and regulatory compliance.
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The purpose of this SOP is to establish procedures for the identification, assessment, and management of risks associated with pharmaceutical products throughout their lifecycle.
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The purpose of this SOP is to outline procedures for the investigation and evaluation of safety signals identified during pharmacovigilance activities.
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The purpose of this SOP is to establish procedures for reporting adverse events associated with medical devices in compliance with regulatory requirements.
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The purpose of this SOP is to ensure compliance with International Conference on Harmonization (ICH) guidelines related to pharmacovigilance activities, including safety reporting, risk management, and regulatory submissions.
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The purpose of this SOP is to establish standardized procedures for the coding of adverse events and medical conditions using the Medical Dictionary for Regulatory Activities (MedDRA) terminology in pharmacovigilance.
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The purpose of this SOP is to establish procedures for managing queries in the pharmacovigilance database to ensure accurate and timely data retrieval for safety assessment and regulatory reporting.
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The purpose of this SOP is to define procedures for the systematic evaluation, prioritization, and management of pharmacovigilance signals to ensure timely identification and assessment of potential safety concerns.
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The purpose of this SOP is to establish procedures for the review, approval, and submission of pharmacovigilance aggregate reports to regulatory authorities.
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The purpose of this SOP is to define procedures for reviewing and assessing pharmacovigilance case narratives to ensure accuracy, completeness, and compliance with regulatory requirements.
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