Post Marketing Safety Operations

Medical information call centers play a key role in the post marketing surveillance. The trained professionals provide precise validated information on medicinal products and their safety use.
The expert team would be responsible to provide therapeutic details, scientific information and product details which in turn supports health care professionals, patients to understand the safety and efficacy of the medicinal product or the product quality complaints. As an integral part of the post marketing surveillance the call center professionals are trained to capture the adverse event form by precisely querying for relevant information to complete the adverse event form. This is a round the clock set up to address the queries of the health care professionals, patients, care takers with the right to information as well consider collecting the adverse event experienced by the patients. The expert team ensures to maintain the confidentiality of the data privacy, and enabled confidential transfer of the data to the sponsor.

Our expert team provides immaculate end to end case processing services throughout the life cycle of the medicinal product. It is imperative that the volume of the case reports generated during post marketing is much higher compared to other phases of the clinical trial. We possess the perfect team who bring in tremendous knowledge in various therapeutic segments and also manage case processing of high volume drugs/ medicinal product. The team is well versed in processing case reports in various databases. Over the years of experience, we have had an opportunity to plug in robotic process automation (RPA) to certain fields that have redundant, yet important information for a complete case report. This has enabled us to reduce the timeline in processing of a case report since our experts focus on the important data points and validate the information that were automatically transcribed to the database via RPA. The strategic way to assured quality of a case report is achieved by implementation of ‘Do it right the first time’ and quality check points implemented at different levels of case processing.

Aggregate reporting involves the compilation of the cumulative safety data for a medicinal product from a wide range of sources for a designated period of time as described by the reporting country regulatory authority. These aggregate reports are submitted to regulatory authority as soon as the medicinal product is marketed anywhere in the world. These reports empower to understand the benefit risk profile of the medicinal product over a period of time. These reports require distinctive diligence to detail the safety and efficacy of the medicinal product. The eminent team at our company are well versed with the PSUR structure and the format described in the Regulation Article 35 and Module VII of the Guidelines on good pharmacovigilance practices. The expert team manages the data lock points published by the EURD list and submits the reports in a timely manner. The team also expertise’s in managing the PBRER report as described by ICH-E2C (R2) guideline which is used as a basis for the EU PSUR. The team conspicuously highlights on the risk management initiative to the regulatory authorities. The renowned aggregate reporting scientists add value in the development of PADER reports as a part of the post cumulative safety reports to the USFDA.

Risk management plan is a key to success of any medicinal product released to the market. The risk management plan further emphasizes on the activities of the marketing authorization holder to supplement the characterization of safety profile during post marketing surveillance. We have the privilege of working for different regulatory requirements and customizing the reports to include the identification, analysis, planning, mitigation and monitoring. The team expertise in writing the contingency plans to mitigate and monitor the risk involved. The team also proposes the best practices to measure the effectiveness of risk-minimization measures. The team also addresses the classification of changes to the RMP, submission requirements and many more aspects to be considered in the procedures involved in the management of RMP. The team also has knowledge on working on stand- alone variation document for changes in safety concerns that needs to be submitted outside another procedure.

A risk evaluation and mitigation strategy is a drug safety program in the United States food and drug administration. This is required for certain medicinal products with serious safety concerns where the volume of serious adverse events recorded is higher to help ensure the benefits of the medicinal product outweigh the risks. The purpose of this strategic document is to strengthen the medication use behavior and actions that favors the safe use of the medicinal product. The skilled team have experience to reinforce the communication to health care providers in the medication prescribing information. The team focus on preventing and managing the serious risk by informing, educating and reiterating actions to reduce the frequency and severity of the serious event. The expert team provides support for any FDA inspections to evaluate compliance with risk evaluation and mitigation strategies requirement. The team provides their expert advice on best practices to implement risk-based approach.

Scientific and medical literature is the prime source of information to understand the suspected serious adverse event case reports. It is the need of the hour in the post marketing safety operations to understand the safety and efficacy of the medicinal product. The screening and review process enables to bring in clarity and focus on the medicinal product. It also enhances to broaden our knowledge base and interpret ate the findings for further surveillance. Our expert team screens the literature to identify adverse event reactions or any other relevant information. The team focus on identifying records such as individual case reports, PSURs, PBRER and DSUR. The team emphasis on safety information to be monitored by marketing authorization holders on off-label use, misuse, drug abuse, drug-drug interactions. The proficient team provides periodic screening of literature review in most of the widely used reference databases such as Medline, Embase etc.,

A safety signal is an information on any new serious adverse event/life threatening/ death event that has occurred which needs further investigation of the medicinal product. The safety signals can be detected from varied sources such as spontaneous reports, clinical studies and scientific literature. It is a collaborative responsibility of the regulatory authority and marketing authorization holders for detecting and managing safety signals. We have dedicated team to focus on the US requirements by extensive data mining across FDA AERS, clinical trials and other data sets. We also have expert team to manage the Eudravigilance database for suspected adverse reactions and signals as per the EU requirement. We also provide value added service by automated analysis capabilities for aggregate data review. We have a robust signaling and surveillance charter that allows the teams to tailor make the workflows and identify signal thresholds for various medicinal products.

The company core data sheet is an internal document owned by the marketing authorization holder. It provides the safety profile of the drug and also serves as the basis for prescribing a medication. This is also used for global advertising and promotional activities. The intention of developing a company core data sheet is to align the labelling information of the medicinal product across the globe and also to have the reference safety information for the assessment of the aggregate reports of the medicinal product. The company core data sheet also includes information on approved indications, doing requirements, method of administration, exceptional update on pregnancy and lactating mothers, packaging and storage requirements and also its limitations. At our company we have the required cross functional experts from medical affairs, drug safety, pharmacokinetics and pharmacodynamics (PKPD), toxicology, labeling group to play a collaborative role in updating the company core data sheet. We bring in diverse perspective, in depth data analysis and ensure the consistency of the information in the company core data sheet.

Summary of product characterization is the basis of information for healthcare professionals on how to use the medicinal product safely and effectively. The package leaflet is designed in accordance to the SmPc. The guidelines on excipients in the label and packaging information leaflet of medicinal products for human use is applicable to SmPc. It acts as a objective document for a given generic molecule. Since the data is already available for the reference medicine, the study also involves the demonstration of same levels of active substance in the body as the reference medicine including the safety profile of the generic molecule. The medical professionals play a vital role in managing the integrity of each section of the SmPc document. The team focuses on providing detailed information to deal with the issues that is applicable to the core population using the generic molecule. The team efficiently manage the thorough analysis of the reference medicine while updating the SmPc for generic molecule.

Health authority response plays a critical role in safety profile of the medicinal product even during post marketing surveillance. It is responsible to manage the health security of the patients. In order to achieve this health authorities, conduct periodic check points at various levels of the life cycle of the clinical trial. The health authorities also ensure to conduct periodic check for safety profile of the drug as integral part of post marketing surveillance. It is important to provide all the relevant information in a structured manner to prove the safety and efficacy of the medicinal product. At company, we provide solution based approach to meet the requirements of the health authority within the assigned timelines. The team ensures enclosure of all relevant documentation to prove the integrity of the medicinal product. The team also shall propose corrective and preventive measures and measure the effectiveness of the solution proposed. The team shall conduct health check internally to ensure compliance.