Although drugs are passed through a series of trials to establish their efficacy and safety in human beings before they get marketing approval, not all the adverse effects caused by a drug can be detected in clinical trials, especially uncommon ones and those appear on long-term administration of that drug because clinical trial results are limited by strict inclusion criteria, relatively small sample size and short study period. Hence, it becomes necessary to have a system that keeps strict vigilance over and is able to disclose such type of adverse drug reaction(s) (ADRs) after marketing approval of drugs. Spontaneous reporting is one of the most widely utilized methods of pharmacovigilance.
Aggregate reporting is the process that reviews the cumulative safety information from a wide range of sources, on a periodic basis and submits the findings to regulators worldwide.
The aggregate safety reports are presented to regulators as soon as the medicine is marketed anywhere in the world and enables understanding of risk and benefit profile of the product over a period of time.
These reports focus not so much on individual cases, but rather on overview, assessment of the safety profile and benefit-risk-evaluation of Adverse Drug Reaction (ADR) and the Serious Adverse Event (SAE) and pregnancy reports.
Over time it was recognized that the risk of the marketed drug should be assessed in the light of its benefits and change in the risk estimate overtime. Consequently, the report name was changed to Periodic Benefit-Risk Evaluation Report (PBRER).
PBRER are mandatory for all approved medicinal products.
This report provides an analysis of the safety, efficacy, and effectiveness of the product over its lifecycle. Most information will likely be related to safety, but information on any new limitations of medicine and alternative treatment areas also needed to be included.
In simple terms, PBRER means submitting safety information to Regulatory authorities periodically. But in practice the Regulatory requirements make the process much more complex.
A signal is essentially a hypothesis of a risk with a medicine with data and arguments that support it, derived from data from one or more of many possible sources.
The evidence in a signal is not conclusive (is, in the technical sense, uncertain), and is only an early indication (preliminary), as it may change substantially over time as more data accumulates.
The evaluation of safety signals should be a continuous process in pharmacovigilance, and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on potential PV risks, as needed.
Scientific & medical literature is a significant source of information for the monitoring of the safety profile and of the risk benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.
Literature report is any adverse drug reactions reported in
Pharmaceutical products are associated with risks that must be managed efficiently to prevent patient harm. Regulatory agencies have mandated risk assessments and safety surveillance for all pharmaceutical products.
Risk Management Plan in pharmacovigilance and Risk Mitigation Strategies outlines the measures taken to minimize those associated risks with a substance or product.
Both sets of procedures detail important activities that maintain patient safety during different life cycle management stages- from research through the market authorization to post-approval monitoring phases. While they differ on how the risk minimization actions will be executed and monitored, they provide the essential guidance that is needed for the appropriate identification and management of patient safety risk associated with a product.
The PSMF is a mandatory part of pharmacovigilance compliance. The Regulatory Directive requires an MAH to have a PSMF if they hold market authorizations (MAs) for one or more medicinal products within the EEA.
The PSMF documents the MAH’s compliance with legal requirements in the EU/EEA and provides a detailed description of all pharmacovigilance activities performed by the MAH to ensure the safety of its products.
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The pharmacovigilance quality management system (QMS) can be defined as the framework of the policies, procedures and systems that are necessary to ensure that the activities relating to the detection, assessment, understanding and evaluation of adverse effects or any other medicine-related problem relating to medicinal products are handled in compliance with applicable laws, regulations and company expectations.
The purpose of a QMS is to ensure that all pharmacovigilance activities are performed to the highest ethical standards and conform to relevant regulatory requirements and contractual obligations to any licensing partners. Key elements include a quality policy, an approved documented library of SOPs, quality control procedures, key performance indicators (KPIs), job descriptions, and training plans. It also cover organizational structure, responsibilities, procedures, processes and resources of the pharmacovigilance system as well as appropriate resource management, compliance management and record management.
Quality Person for Pharmacovigilance (QPPV) is responsible for the management of pharmacovigilance and quality activities on behalf of a pharmaceutical organization.
QPPV is a point of contact for regulatory authorities with respect to the benefit-risk data of a product and must ensure that MAHs have an adequate pharmacovigilance system in place that is compliant with the regulatory requirements of the region.
QPPV oversees various pharmacovigilance activities that include quality audits, signal management and preparation of audits and training among others. Global authorities have mandated the appointment of a QPPV for countries in which medical products are to be authorized where each region has its own set of requirements for a QPPV- from their qualification to their citizenship/residential status.
Safety System implementation or Upgrade require substantial time, money and effort. Our well-crafted methodology adds efficiency on all 3 counts, by minimizing rework loops thereby reducing project duration, effort and cost. This methodology provides flexibility to meet specific business/operational needs across varied spectrum of Clients ranging from small-medium businesses to Tier one’s along with ensuring error-free results.
Cosmetovigilance is a new concept of safety monitoring of cosmetic products which refers to the post marketing surveillance of any health-related undesirable effects possibly due to the use of cosmetic products. The purpose of Cosmetovigilance is to collect, analyze and assess the adverse reactions occurring in consumers to identify any potential health risks, thus guaranteeing a further strengthened safety for consumers.
Cosmetovigilance also allows to control or rule out potentially hazardous ingredients that may be present in cosmetic products.
Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical devices. Its primary purpose is to protect and improve safeguards for patients, users and others by preventing or reducing the likelihood of reoccurrence of incidents elsewhere.
The vigilance system achieves its objectives in the following ways:
Like drug pharmacovigilance, vaccine pharmacovigilance aims to detect adverse events early to trigger accurate risk assessment and appropriate response (risk-management) to the problem. This ensures the minimization of negative effects to individuals. Another goal of vaccine pharmacovigilance is to lessen the potential negative impact on immunization programs.
Vaccines, like other pharmaceutical products, undergo extensive testing and review for safety, immunogenicity, and efficacy in the laboratory, in animals, and in three phases of clinical trials in human subjects before marketing. Monitoring adverse vaccine reactions is a major safety component of pre-marketing clinical trials and after
The need for regulatory intelligence, and strategic input has significantly increased in parallel with the ever-changing regulations and rise in complexities surrounding product approval. Be it clinical trials, pharmaceutical product development, or post-submission senior management and other key stakeholders within a pharmaceutical organization require Regulatory Intel and comprehensive strategic advisory support that tackle challenges associated with rapid developments of the regulatory landscape. This ensures rapid market access for pharmaceutical products in desired regions, compliance, increased business value, and market competitiveness.
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