An important aspect of patient safety is Pharmacovigilance, that is the science and activities relating to the Detection, Assessment, Understanding, and Prevention of adverse effects or any other medicine-related problems. As an end-to-end pharmacovigilance services provider, DDReg is a key stakeholder in the drug safety spectrum and is committed to ensure utmost patient safety. Our pharmacovigilance services are compliant with the requirements of stringent regulatory authorities like EMA, UK MHRA and US FDA and are based on Good Pharmacovigilance Practices Guidelines.
Individual Case Study Reports (ICSRs) are important sources of information in pharmacovigilance for adverse events that are submitted to regulatory authorities and stored in central databases which can be accessed by industry, regulatory authorities, healthcare professionals etc., to monitor the safety profile of a drug and reduce patient risk or harm. Our pharmacovigilance team at DDReg is expert in handling all stages of case reporting i.e. Receipt, Duplicate Check, Triage, Data Entry, Quality Check, Medical Review, and Final Submission to competent authorities within the require timeframe. Our case processing is carried out using ICH E2B(R3) compliant database, that is integrated with appropriate dictionaries such as MedDRA and the WHO Drug Dictionary to ensure standardization. Our team ensures that all reports are submitted efficiently, and all product quality complaints & medical information queries are answered in a timely manner.
Information on adverse events and drug efficacy data is important to determine the safety profile of the drug. Published medical and scientific literature such as articles and reports are key sources of adverse event data that is used by healthcare professionals, regulatory authorities, academia, and industry when carrying out the benefit-risk analysis of a product. Furthermore, with patient safety becoming an increasing concern, regulations surrounding medical literature as safety data sources are becoming stringent. This presents challenges for manufacturers and marketing authorization holders. Therefore, literature monitoring is crucial to ensure that the sources are continuously monitored. DDReg conducts meticulous and systematic weekly literature reviews of publications in various databases such as PubMed, MedLine and Embase, and monitors ICSRs that are received through patient reports. Our team assists in creating detailed literature search strategies and tracks literature cases.
The safety profile of a drug is not entirely known until the drug reaches its post-marketing stage, as in pre-marketing stages, clinical trials are conducted on a limited patient population in controlled environments. As larger patient populations take drugs for longer periods of time, safety information, adverse effects and risks that were not previously known are identified. Risk management encompasses all activities related to risk identification, evaluation, prevention, and timely communication on potential risks associated with products. Risk Mitigation Strategies and Risk Management Plans highlight proactive measures that should be taken to reduce these identified risks. DDReg drafts, reviews, and maintains risk management plans and risk evaluation & mitigation strategies while providing seamless support in submission. Our team diligently evaluates identified risks, potential risks and missing information to develop risk minimization measures (RMMs), such as Post-Authorization Safety Studies, and conveys all risks through SPCs and PILs. Some of the medicinal product require additional risk minimization measures – DDReg risk management team helps organizations to develop & implement such additional RMMs as well.
Aggregate reporting provides a systematic approach to periodically monitor adverse drug reactions in order to enhance patient safety. Periodic review of safety reports is important in assessing the safety profile of a drug, as it provides accurate safety data associated with the drug. DDReg meticulously reviews periodic data on ADRs and vigilantly drafts aggregate reports in line with regulatory guidelines for the associated region. We offer addendums per the ICH, EMA, and FDA requirements and templates and our in-house tools and databases facilitate report management while minimizing potential errors. Our experts are involved in the initial data collection and compiling reports accordingly, followed by submission to the relevant competent regulatory authorities. These include PBRERs, PSURs, PADERs, DSURs, and ASRs.
Safety signals arise from a spectrum of sources such as literature, clinical studies, and spontaneous reports among many others. Evaluating safety signals establish whether there is a relationship between the reported adverse event and drug to provide regulatory authorities with the most updated information on the safety profile for a drug. Our team conduct detailed analysis for early signal detection and creates signal detection and monitoring plans for our customers. We detect new safety signals and changes in risks associated with a drug from various sources including but not limited to ICSR databases, regulatory agency websites, aggregate reports and more.
In order to truly improve patient safety, pharmacovigilance activities must be managed appropriately. Here, the role of a Qualified Person for Pharmacovigilance (QPPV) or Responsible Person for Pharmacovigilance (RPPV) is integral as they oversee activities, and act as a point of contact for regulatory authorities regarding safety information for a drug. DDReg’s team of QPPVs/RPPVs around the world provide endless support in establishing robust pharmacovigilance systems while maintaining compliance with all requirements.
AUDIT & COMPLIANCE
Pharmacovigilance audits are important as they confirm that an organizations pharmacovigilance activities are compliant with the stringent regulations and laws that are put in place for patient safety. Our audit team reviews and evaluates pharmacovigilance systems in terms of their efficiency, implementation, and operation. We are committed to patient safety by ensure that all systems and processes adhere to ICH E2B(R3), E2C(R2), E2E, GVP modules, FDA, etc.