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Pharmacovigilance

REMS Logic Model: Framework to link program design with assessment

Blogs, Pharmacovigilance, Regulatory / By

Risk Evaluation and Mitigation Strategies (REMS) helps the FDA in ensuring that the benefits of a drug outweigh its risks. These strategies are particularly important for medications with significant safety concerns and require a well-structured approach to both design and assessment. The FDA’s guidance on the Risk Evaluation and Mitigation Strategy (REMS) logic model presents …

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The Impact of Interactive Safety Graphics in Clinical Settings

Blogs, Clinical Regulatory, Pharmacovigilance / By

The world of regulatory submissions is transforming where static documents and data tables are slowly giving way to a more dynamic approach – interactive safety graphics. Traditional methods of presenting this data have evolved significantly with the advent of interactive safety graphics. These dynamic tools are transforming the way submission content is reviewed, how clinical study reports …

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Leveraging Statistical Approaches in Drug Safety Analysis

Blogs, Clinical Regulatory, Pharmacovigilance / By

Drug safety in clinical trials is ensured through the application of statistical approaches. Adequate planning for safety analyses helps in identifying potential adverse events, evaluating their impact and ensuring that the benefits of a drug are greater than the risks associated with it. It starts from early stages i.e., with the designing of clinical trials …

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Pharmacovigilance in New Zealand

Blogs, Pharmacovigilance / By

Medsafe oversees pharmaceutical product regulation in New Zealand and operates under the Medicines Act 1981 which mandates sponsors to report substantial untoward effects of their medicines. The requirement for regulations are highlighted in the Guidelines on the Regulation of Therapeutic Products in New Zealand (GRTPNZ) which also has a Pharmacovigilance (PV) guidance document. This provides …

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Commitment to Biological Product and Patient Safety in India

Blogs, Pharmacovigilance, Regulatory / By

Biological products are derived from living organisms or cells encompass a wide array of essential medical interventions, including vaccines, gene therapy products, and blood derivatives.  Thus, these products are relatively complex in nature which is why there is a need to maintain heightened vigilance and continuously monitor their safety and efficacy. It is crucial to …

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Asserting Patient Rights: The Importance of Labels for Medical Device Traceability

Blogs, Pharmacovigilance, Regulatory / By

In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is …

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Strengthening Safety Compliance in Somalia

Blogs, Pharmacovigilance / By

The National Medicine Regulatory Authority (NMRA) of the Ministry of Health regulates and controls regulatory & safety related operations for pharmaceuticals in Somalia. It is responsible for facilitating the availability and accessibility of safe and effective medicines to the Somalian population. More recently, the Somalian NMRA issued their very first Somali Pharmacovigilance Guideline with the …

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SwissMedic: Strengthening Safety Signal Reporting for Veterinary Products

Blogs, Pharmacovigilance / By

Efficiently detecting safety signals for veterinary products is crucial for safeguarding animal health and ensuring the well-being of both animals and humans. Rapid identification of potential risks allows for timely intervention, preventing widespread harm. Recognizing the significance of this, global authorities are actively working to fortify safety signal reporting. Establishing regulatory guidelines ensures a standardized …

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Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid

Blogs, Pharmacovigilance / By

Pharmacovigilance in India has come a long way over the last few years especially for proactively detecting safety signals for pharmaceutical products. It is an indispensable component of the pharmaceutical industry in India, ensuring the safety and efficacy of drugs in the market. This comprehensive field includes various sub-categories, each contributing to the overall goal …

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Development of Pharmacovigilance Training Modules for US-based Educational Institute

Case Studies, Pharmacovigilance / By

Customer Requirement: A USA-based educational institute specializing in providing training courses to its subscribers was looking to develop a course on pharmacovigilance. This course would be the first of its kind for the educational institute and would aim to provide a robust foundational knowledge base of pharmacovigilance, including key activities, processes, and the regulations surrounding …

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