ProRelix Research understands the utmost importance of protecting patient safety from clinical trials to real-world use of a new drug, biological or medical device. We help you develop appropriate pharmacovigilance plans and adverse event reporting systems in compliance with US FDA regulations and good pharmacovigilance practices.
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any drug related problems. Unlike drug safety monitoring which is an ongoing aspect of preclinical research through the clinical trial phase and involves assessment of side effects during clinical trial, pharmacovigilance is focused on identifying adverse events in a ‘real-world’ setting. Patient compliance, inclusion/exclusion criteria, co-morbidity profiles, concomitant medicines and food intake, and monitoring are not the same in the real-world compared to the controlled environment of clinical trials exposing patients to more adverse drug reactions and adverse events.
The large percentage of post-marketing safety events make it necessary to develop a robust a pharmacovigilance program which involves reporting of adverse events and preparation of risk management plans (RMP) and risk evaluation and mitigation strategies (REMS). Adverse events (AE) are defined as untoward medical occurrences in patients or clinical investigation subjects which may not necessarily have a causal relationship with the drug treatment. AE include medication errors, drug-drug interactions, drug-food interactions, and misuse or abuse of the drug in addition to the direct effects of the drug.
The United States Food and Drug Administration (FDA) has developed a database that contains adverse event reports, medication errors, and product quality complaints called the FDA Adverse Event Reporting System (FAERS). Voluntary reporting by healthcare professionals, consumers, and manufacturers can be submitted on the FAERS database using the MedWatch website which is the FDA’s “Safety Information and Adverse Event Reporting Program” for reporting adverse and sentinel events. Furthermore, the FDA has released draft guidance’s related to good pharmacovigilance practices and pharmacovigilance activities that provide details on pharmacovigilance activities in the post-approval period and safety specifications, and pharmacovigilance plans that might be submitted at the time of license application. Under the Code of Federal Regulations Title 21 CFR 314.80, expedited reports must be submitted to the FDA for serious and unexpected adverse events and non-expedited reports for non-serious events (expected or unexpected) should be submitted quarterly for the first three years for a new drug.
The FDA emphasizes the need for timely communication and documentation of any safety concerns and adverse events using the principles of good reporting practices. Development of comprehensive case reports and case series, database searching for collation of all safety events helps to identify safety signals warranting further investigation. Although the development of risk management plans is not mandated by the FDA, the FDA may require development of a REMS strategy for a drug that it has deemed to be associated with a specific risk that requires mitigation.
We provide the following services in the pharmacovigilance space according to the US FDA regulatory requirements and recommendations to ensure compliance and patient safety
- Preparation of Individual Case Safety Reports (ICSR) through interactions with health care practitioners, targeted questionnaires, and computer-assisted technologies
- Comprehensive database searches using sponsor’s global adverse event databases, FAERS, or vaccine adverse events reporting system (VAERS) using MedDRA terminology, scientific literature
- Design of surveys, registries, and pharmacoepidemiologic studies for safety signal evaluation
- Development of case series using databases
- Submission of periodic safety update reports such as the Periodic Adverse Experience Report (PADER) or Periodic Benefit Risk Evaluation Report (PBRER)
- Preparation of Risk Evaluation and Minimization (REMS) programs: educational materials, special labeling requirements, monitoring activities, communication programs
- Expedited and Aggregate report development and writing
- Preparation of Standard Operating Procedures (SOP) for pharmacovigilance-related activities
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