Clinexel Life Sciences Pvt Ltd

Local Person Responsible for Pharmacovigilance: Every marketing authorization holder (MAH) must implement a pharmacovigilance system to ensure the safety of their products and the well-being of patients. In the European Union (EU), a pharmacovigilance system is defined as a system employed by an organization, such as MAH, to meet its legal duties and responsibilities regarding drug safety monitoring. This system is designed to track the safety of authorized medicinal products and identify any changes in their risk-benefit balance. There are more elements included in the PV System including but not limited to the processes to collect, analyse and report adverse event reports from all sources, literature, post marketings, clinical trials, aggregate report writing, signal management, Risk Management Plan, the Pharmacovigilance System Master File, Safety Data Exchange agreements, SOPs, working instructions, documenting and archiving. There are many different requirements that exist in the EU. When establishing a pharmacovigilance system, the primary consideration is determining the countries for which a Local Person Responsible for Pharmacovigilance (LPPV) is required. Not all European countries mandate an LPPV, which necessitates categorizing them as follows: · Countries not requiring an LPPV · Countries requiring an LPPV · Countries recommending an LPPV · Countries with other specific requirements Countries requiring an LPPV under specific circumstances, such as type of registration central or national, stage in the product life cycle application, post-authorization, post-launch, or language capabilities of the Qualified Person Responsible for Pharmacovigilance (QPPV) or LPPV. Understanding the point in the product life cycle when an LPPV is required is crucial. This requirement may arise at different stages, including submission of the marketing application, marketing authorization, or initial product launch. It may also vary depending on the authorization procedure or the need to collect pharmacovigilance data or conduct a Post- Authorization Safety Study (PASS). Many countries require their LPPV to speak the local language(s), and many require that the LPPV should reside in the country. If the EU QPPV lives in the country and speaks the local language, they may also serve as an LPPV. However, there can be exceptions, so it should not be assumed that having a QPPV in the country eliminates the need for an LPPV. Clinexel’s fast growing network of experienced QPPVs and LPPVs can support you to implement an LPPV network while you are planning to approach the EU or any other market in the world. For more details and your any specific requirements, please speak with one of our QPPV/LPPV experts and reach out to #[email protected], Clinexel Life Sciences Pvt Ltd #pharmacovigilancesetup #drugsafety #myclinexel #LPPV #QPPV #clinexelcro #patientsafety #clinicaltrials #pharmacovigilance #clinicalresearch #Earlydevelopment

Writing high quality narratives for Clinical Study Reports High-quality narratives within the Clinical Study Reports (CSRs) serve as the backbone for presenting complex data on Serious adverse events (SAEs) and deaths in an understandable and insightful manner. Narratives should be well organised, complete, free from ambiguity and easy to review. Crafting compelling and precise narratives can significantly impact the interpretation and credibility of clinical findings. According to ICH E3 guidelines, there should be brief narratives describing each death, each other serious adverse event, and those of the other significant adverse events that are judged to be of special interest because of clinical importance. The ICH E3 guidelines further indicate that events which are clearly unrelated to the test drug or investigational product may be excluded from detailed reporting or summarized briefly. A patient safety narrative should detail: • The event’s nature, intensity, and outcome • The clinical course leading up to the event • Timing in relation to test drug/investigational product administration • Relevant laboratory results • Actions taken with the study drug and timing • Post-mortem findings, if applicable • Causality opinions from the investigator and, if relevant, the sponsor Additionally, patient identifier, age, gender, clinical condition of patient, disease being treated with duration of illness, relevant historical/concurrent conditions with duration and concomitant/prior medications with therapy details should be included. The narrative should also include the information of test drug/investigational product administered, drug dose, if this varied among patients, and the duration of administration. At Clinexel, we focus on understanding current regulatory requirements for safety narratives and developing a streamlined process for their creation and review. Our goal is to simplify the reporting process, thereby reducing both time and cost burdens. Our process for producing high-quality patient safety narratives involves several key steps: • The narrative writer prepares the initial draft from various source files. • This draft is reviewed for accuracy and consistency through scientific and editorial peer review. • The draft undergoes a clinical review, followed by revisions by the narrative writer. • During drafting of narratives, initial and follow-up SAE reports, patient data listings, protocol deviations and laboratory reports are duly considered. • A Quality Control (QC) review is performed with final subject data, leading to additional revisions if necessary. • The final narrative is reviewed and approved by the Sponsor. Reach out to us at [email protected] to know more about Clinexel Team’s expertise and experience in authoring high quality narratives for Clinical Study Reports. #clinexelcro #Patientsafety #Clinicaltrials #clinicalsummaryreport #Pharmacovigilance #Clinicalresearch #Earlydevelopment #innovatormolecule

I’m happy to share that I’m starting a new position as Assistant Manager at Clinexel Life Sciences Pvt Ltd !

#Hiring at #Clinexel #Clinexel is a #fullserviceCRO, providing #pharmacovigilance and clinical research services. We are working on #investigational products, marketed products and #medicaldevices, conducting phase 1 to phase 3 clinical trials, post marketing studies, and #PMCF studies. We are hiring for the following office-based positions- 1. #CRAs (Clinical Research Associates) 2. #Biostatistician 3. Clinical Trial Project Managers 4. Quality Assurance Executive We are looking out to hire dynamic and experienced candidates with postgraduate and/ or doctorate degree in Pharmacy with minimum of 3-5 years of experience in pharmaceutical industry in their respective fields. The candidates are required to have good hands-on experience on working with MS word, adobe acrobat, MS excel and other basic computer tools. Kindly note that all positions are office based at Palm Beach Road, Navi Mumbai. Working with #Clinexel At #Clinexel, you will get an opportunity to work with new therapies and challenging projects with the Sponsors from across the Globe. We believe that TOGETHER we can advance the healthcare and thereby, change the life of the patients. At #Clinexel, we focus on all round development of team members and provide them the required growth and learning opportunities to succeed. At Clinexel Peers, Managers and Leaders partner to create a work culture of care, respect and inclusion. Apply today to join our team and make a difference in the healthcare industry! #pharmaceuticalindustry #clinicaltrials #PMCFstudies #medicaldevices #pharmacovigilance #postmarketingstudies #healthcare #clinicalresearch #jobsearch #clinexel #clinexelcro #medicalwriters #cra #biostatistics #pmcf #medicaldevices

Drug Approvals via 505(b)(2) / Hybrid Pathways A drug submitted via 505(b)(2) can be approved based on data from studies not conducted by the sponsor, by relying on Agency’s previous findings of safety and effectiveness of an approved drug; and/or (2) clinical and preclinical studies’ data from published literature without the right of reference. This requires not only a successful bridging to an RLD by the means of relative BA/ BE studies, but also some potential additional clinical trials to fully support the efficacy and safety of the new product. bioavailability. Clinical Pharmacology (CP) plays a critical role in the approval of 505(b)(2) NDAs. Some of the critical CP aspects that need to be considered and addressed during the planning and submission of a 505(b)(2) NDA include study design of the pivotal BA/BE study, biowaiver related discussion, need for additional or supportive pharmacokinetic information to be included in the NDA, selection of the most appropriate reference drug product for 505(b)(2) purpose, as well as acceptability of publicly available information to address data gaps in knowledge. Routing products through 505(b)(2) NDAs is beneficial for the industry as it reduces the risk of failures due to safety and/ or efficacy. Thus, the overall cost of development reduces significantly. As many of the 505(b)(2) NDAs are product enhancements to ease administrations and enhance compliance, these are beneficial for the patients. At the beginning of the program, it’s important to determine whether to submit an ANDA or 505(b)(2) or supplement NDA if the sponsor has access to the originator data. In the first quarter of 2024, the US FDA has already approved 10 505(b)(2) NDAs. Some of these include Talazoparib (TALZENNA), oral capsule of Pfizer of breast and prostate cancer, CABAZITAXEL, IV solution of Actavis for Castration-resistant prostate cancer, Budesonide (EOHILIA), oral solution by Takeda for eosinophilic esophagitis, Vortioxetine(SEHIPPY), ODT of Seasons Biotechnology Co Ltd for Major depressive disorder in patients with dysphagia #505b2 #clinexel #clinexelcro #drdeepaarora #505b2nda #hybridpathway

Joint #usfda #healthcanada #mhra symposium on Good Clinical Practices and Pharmacovigilance It's wonderful to be back in Maryland after several years and in person participate in the joint symposium organized by the #usfda #healthcanada #mhra on #gcp and #gvp On day-1, one of the key topics discussed was Decentralized Trials (#dct ), a great opportunity to learn and understand from the case studies about how to plan and document at an early stage various elements of #decentralizedtrials relevant data flow as well as the retention and availability of data for #gcpinspections at a later stage Looking forward to 3 full days of learning and interacting with experts and stalwarts. #clinexel #clinicaltrials #clinicalresearch #clinexelcro