An essential component of patient safety is pharmacovigilance, which encompasses the science and activities involved in detecting, assessing, understanding, and preventing adverse effects or any other medicine-related issues. As a comprehensive pharmacovigilance service provider, DDReg plays a crucial role in the drug safety landscape and is fully committed to ensuring the highest level of patient safety. Our pharmacovigilance services meet the stringent requirements of regulatory authorities such as the EMA, UK MHRA, and US FDA, and are based on Good Pharmacovigilance Practices (GVP) guidelines.

ICSR Processing

Individual Case Safety Reports (ICSRs) are vital for monitoring adverse events and are submitted to regulatory authorities, where they are stored in central databases. These reports can be accessed by industry professionals, regulatory bodies, and healthcare providers to track the safety profile of a drug and minimize potential patient risks or harm.

Literature Monitoring

Published medical and scientific literature, such as articles and research reports, are critical sources of adverse event and drug efficacy data. This information is essential for assessing a drug's safety profile. Healthcare professionals, regulatory agencies, academia, and the pharmaceutical industry use this data when conducting benefit-risk analyses of medicinal products.

Risk Management

A drug’s complete safety profile is not fully understood until it reaches the post-marketing phase. During pre-marketing, clinical trials are conducted with a limited group of patients in controlled settings.

Aggregate Reports

Aggregate reporting offers a structured method to continuously monitor adverse drug reactions and improve patient safety. 

Signal Management

Safety signals can be derived from a variety of sources, such as clinical trials, literature, and spontaneous reports, among others. Analyzing these signals helps determine if there is a connection between the reported adverse event and the drug, ensuring that regulatory authorities receive the most up-to-date information regarding the drug’s safety profile.

QPPV Services

To truly enhance patient safety, pharmacovigilance activities must be managed effectively. The role of a Qualified Person for Pharmacovigilance (QPPV) or Responsible Person for Pharmacovigilance (RPPV) is crucial.

Audit & Compliance

Pharmacovigilance audits are essential in confirming that an organization's pharmacovigilance activities comply with the rigorous regulations designed to ensure patient safety.

For More, Check Out our Post -: https://resource.ddregpharma.com/blogs/pharmacovigilance-services-at-ddreg-our-commitment-towards-patient-safety/

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