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Postmarketing Adverse Drug Experience (PADE) Inspections – Part II Legal Framework of PADE Inspections LAW: Federal Food, Drug and Cosmetic Act (FDCA) Title 21 of ...

Postmarketing Adverse Drug Experience (PADE) Inspections – Part I Legal Framework of PADE Inspections LAW: Federal Food, Drug and Cosmetic Act (FDCA) Title 21 of ...

Drug-Induced Liver Injury Occurrence Most frequent cause of acute liver failure in North America and Europe. No definite causative agent has been attributed in several ...

Drug-Induced Liver Injury Occurrence Most frequent cause of acute liver failure in North America and Europe. No definite causative agent has been attributed in several ...

Essential Automation Solution Components Technology Digital Monitoring of Safety Communications with site Tracking of Delivery Receipts and Acknowledgement Compliance Custom Configurations for Site Reminders and ...

US-FDA United States Food and Drug Administration The sponsor must notify all participating investigators (i.e., all investigators to whom the sponsor is providing drug under ...

REMS are Enforceable under Section 505-1 REMS must be fully operational before drug introduced into interstate commerce. Drug is deemed to be misbranded (Section 502(y)) ...

What is REMS? Per the USFDA, REMS is defined as:“A required risk management plan that uses risk minimization strategies beyond professional labeling to ensure that ...

Why Should You Perform Signal Detection in Early Phase Clinical Drug Trials? The term ‘pharmacovigilance’ has conventionally been related with post-marketingactivities; however, it is also ...

Medication errors are an important concern in healthcare systems around the world. They can occur at any stage of the medication process, from prescribing to ...

What is a Safety Signal in Pharmacovigilance? Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, ...

Artificial Intelligence, Machine Learning, Automation, Cost Reduction: all the buzzwords in pharmacovigilance! Everyone seems to be implementing Automation and AI in pharmacovigilance to reduce manual ...

Meteriovigilance is the term used in the context of surveillance of medical devices and its purpose is to improve the health and safety of patients, ...

In the realm of healthcare, ensuring patient safety is the most important aspect. That’s where pharmacovigilance plays a role in safeguarding lives by monitoring the ...

An adverse drug reaction is distinguished from an adverse event by the fact that in an adverse drug reaction, a causal relationship is suspected between ...

Decentralised clinical trials make clinical trials easier for patients by reducing the need to travel to clinical sites. They are also known as “Direct-to-participant trials” ...

The medical literature is a vital source of information for monitoring the safety and benefit-risk profile of medicinal products. It is a significant source of ...

Introduction EudraVigilance is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European ...

What is an Annual Summary Report (ASR)? It is a comprehensive assessment of all known safety information for a marketed drug or natural health product. ...

Liver biochemical tests are very commonly performed in clinical studies/clinical practice. These tests include: Alanine/aspartate aminotransferases (ALT/AST), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) Bilirubin, Albumin ...

Serious Adverse Event Reconciliation in Clinical Studies WHAT IS SERIOUS ADVERSE EVENT (SAE) RECONCILIATION AND WHY IS IT REQUIRED​ The aim of Good Clinical Practice ...

Liver Injury With Cancer Chemotherapy Cytotoxic chemotherapy is frequently associated with serum aminotransferaseelevations that are self-limited and that may subside with continued therapy.However, rare occurrences ...

Drug Induced Liver Injury in Premarketing Clinical Trials DILI (Drug Induced Liver Injury) is a rare but potentially fatal adverse drug reaction. DILI is a ...