Case Studies

  • Case Study 1 - Strategic Advice and set up of Pharmacovigilance

    A leading Generics Company with R&D capability with several drugs in clinical development pipeline requested Symogen Limited to help set up and strategise Pharmacovigilance in Europe and globally. Symogen Limited has helped the company in advising on Global PV database set up including systems and processes, CTs safety support, prepare Safety management Plans for drugs in development, set up of and advise on Prescription Event Monitoring (PEM) Studies for drugs in India with KOLs; audit and inspections of all their affiliate offices globally; set up of PSUR processes and systems and authoring; developing and preparing CCDS from scratch and help prepare Safety Data Exchange Agreements (SDEAs).

  • Case Study 2 - Global NDA Submission for Oncology Product

    A MNC requested Symogen Limited to help in the entire PV management and work for global NDA submission of novel Oncology product to FDA, EMA and PMDA. Symogen Limited managed the entire project including assessment, analysis of various data from several Phase II and III clinical trials, DSMB data review, assessment and responding to DSMB, reviewing and authoring of several important documents including Integrated Safety Summary (ISS); Clinical Study Reports; Patient narratives and safety narratives, DDPS etc. Symogen Limited also prepared from scratch the Risk Management Plans, EU SmPC, US PI and other safety documents for eCTD submissions globally. This project was completed by Symogen Limited in 12 months time and well before global submissions that enabled the sponsor company to submit MAA to all the three regulatory agencies FDA, EMA and PMDA before the actual date of submission.

  • Case Study 3 - Good PSUR Practice and Quality Review of PSURs

    A MNC requested Symogen Limited to help them with setting up and strategise a Good PSUR Practice process, as they had received several assessment reports from various regulatory agencies regarding the low quality standard of its PSUR which was one of the triggers for an inspection. Symogen Limited helped the company by spending over four weeks in understanding the current set up and then entirely changed the process and gave training in writing a PSUR including understanding the content and developing a new PSUR template as per EU regulations. Symogen Limited also helped the sponsor company to set up a pilot project for the PSURs and in strategising which PSUR should be done in house and which outsourced. With the implementation of this new process and setting up of the Good PSUR Practice, regulatory authorities have sent positive feedback and assessment reports to the sponsor.

  • Case Study 4 - Signal Detection and Issue Work Up

    A MNC requested Symogen Limited for urgent help to review and close over more than 7000 PT terms each of the Signals for their Transplant and Oncology portfolio group of drugs. This project included detailed analysis of the events and Issue Work Up of these signals identified through Quantitative Signal Detection and Management Tool and then authoring of several Safety Reports for the signals that were generated for submission to the Regulatory Authorities. This project helped the sponsors to get on top of the signals for these therapeutic areas and close all the signals.

  • Case Study 5 - Urgent Safety Issue requiring DHCP Letter

    A MNC requested Symogen Limited to help with an Urgent Analysis and Comprehensive report authoring of a Specific Urgent Safety Issue that had to be submitted to EMA as part of CHMP request. Symogen Limited executed the project by doing a detailed analysis of all the events involved for this specific issue, wrote the entire report consisting of more than 200 pages and also authored the Dear HCP letter for submission to the Regulatory Authority.

  • Case Study 6 - Pre-inspection Assessment of Pharmacovigilance Systems

    A MNC requested a comprehensive assessment of both the pre and post marketing activities in its European headquarters and UK and Irish affiliates, and also requested help and expert advice in the preparation of upcoming MHRA Inspection. Contacted Symogen Limited for under taking Mock Inspection, as PV experts for QPPV Inspection, Inspection for Global Central Operations and Affiliate Pharmacovigilance Inspection. The assessment was conducted over a three-week period by an experienced pharmacovigilance expert and QPPV. The experienced pharmacovigilance expert ensured that the assessment identified key gaps in pharmacovigilance systems, and that pragmatic and effective recommendations for improvements were made. The company received the assessment report very positively and implemented corrective actions before the inspection. For those corrective actions that required a longer implementation period, a plan of action was prepared which was acceptable to the regulatory inspectors. As a result of the assessment, pharmacovigilance personnel were well prepared for the subsequent inspection, which progressed smoothly with very few findings

  • Case Study 7 - MHRA PV Inspections

    A MNC requested Symogen Limited for help with their forthcoming MHRA Inspections in PV after receiving several critical findings in previous inspections from various competent authorities. Symogen Limited helped them by changing and implementing several processes and handled the inspections professionally which resulted in positive comments by the inspectors and less significant findings.

  • Case Study 8 - Development and Preparation of SDEAs:

    A MNC requested Symogen Limited for help with developing and preparing of several SDEAs for various products as part of the commitment following several inspections. Symogen Limited helped the company in preparing these legal documents interacting with pharmacovigilance department, legal department and various other license partners.

  • Case Study 9 - QPPV and Head of Drug Safety Pharmacovigilance Support

    A MNC requested Symogen Limited for help with QPPV and Head of Drug Safety & Pharmacovigilance support. Symogen Limited has helped the company with re-organisation and in providing strategic input for changing the PV department; liaison with all affiliates in setting up the systems and processes with global centres and making the company inspection ready for major inspections.

  • Case Study 10 - Development Safety Update Reports:

    Symogen Limited was appraoched to author several DSURs for products in development. The project was completed with experienced PV physicians and scientists who authored the DSURs for submissions to the regulatory agencies.