- Authoring of RMPs and preparation of SmPCs & CCDS (Get More...)
Date : 09-03-2011
A MNC requested Symogen Limited to help with the authoring of RMP for one of their major products in development and in the preparation of SmPCs and CCDS. This project was undertaken by experienced PV physicians and scientist and submitted as part of MAA to the EMA and FDA.
- Signal Detection & Management (Get More...)
Date : 09-03-2011
A MNC requested Symogen Limited to help with the identification, evaluation and management of over 3000 signals from various major products. Symogen Limited helped complete this project to the highest standards.
- Case Study 1 : Pre-inspection Assessment of Pharmacovigilance Systems (Get More...)
Date : 02-02-2011
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 2 : Medical Evaluation and Analysis of Mortality Cases as Commitment to FDA (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited for urgent help to complete Medical Evaluation and analysis and report write up of more than 5000 mortality ICSRs as a commitment to FDA. The entire work was completed by the pharmacovigilance physicians and scientists to very high standards, which included detailed retrospective medical evaluation and analysis of each ICSR, creating the report template and then authoring the complete report for submission to the sponsors for submission to the FDA in record time. As a result of this report, the sponsors did not receive any further questions from the FDA.
- Case Study 3 : Signal Detection and Issue Work Up (Get More...)
Date : 02-02-2011
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 4 : Urgent Safety Issue requiring DHCP Letter (Get More...)
Date : 02-02-2011
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 5 : REMS & Pregnancy Prevention Plan (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help with REMS for their major product for a particular issue that FDA had requested the sponsors to comply. Symogen Limited authored the REMS and prepared the educational materials for HCP and patients; the DHCP and also prepared the other Risk Minimisation Measures for the Pregnancy Prevention Programme for submission to the FDA.
- Case Study 6 : Counterfeit Medications (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help in detailed assessment, analysis and authoring of counterfeit medications originating for one of their products in Central Asia. Symogen Limited conducted the entire project and an exercise was conducted in getting the entire data from the database, assessing and analysing the data and authoring the report and putting the strategies and processes in place to deal with it in the future.
- Case Study 7 : Drug Contamination Issues for a major product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help with a detailed assessment, analysis and authoring of a report with an important issue of drug contamination for one of the sponsors product. Symogen Limited accomplished this project by working in collaboration with the sponsors affiliate team members and the global team members to complete this project to the highest standard.
- Case Study 8 : Issue Work Up for Major Issues with Transplant Drug (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help with detailed assessment, analysis and writing the report for major Issues involving a transplant drug that the regulatory authorities had requested the sponsor. Symogen Limited undertook a detailed assessment and analysed all the ICSRs and other related documents for these major issues and then wrote the report for submission to the regulatory agency. The regulatory agencies were highly pleased and did not have any questions following the assessment report received by the sponsors on this report.
- Case Study 9 : Good PSUR Practice and Quality Review of PSURs (Get More...)
Date : 02-02-2011
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 10 : Pharmacoepidemiology Report on Metabolic Therapeutic Area (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help them with one of their Pharmacoepidemiology projects on a developmental compound in the Metabolic Therapeutic Area involving a diabetes drug. Symogen Limited conducted an entire literature search and then wrote the report for this project which was included for the NDA submission to the regulatory authorities as part of clinical drug development plan.
- Case Study 11 : Reference Safety Information for Gastrointestinal Products (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help with various activities including medical evaluation, signal detection, risk management plans and development from scratch Reference Safety Information (RSIs) including CCDS for their full range of GI products. Symogen Limited accomplished this project to the highest standards in record time for all of the sponsor’s products.
- Case Study 12 : Pre-inspection Assessment of Pharmacovigilance Systems including QPPV audit (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to undertake a Mock Pharmacovigilance Inspection for their entire PV Systems & Procedures and the QPPV Set up prior to the upcoming EMA and MHRA Inspection. Symogen Limited experienced pharmacovigilance expert during the mock inspections 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 many 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 13 : PSURs for GI and Renal Products (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help in authoring of the entire set of PSURs for various therapeutic areas including GI and Renal. Symogen Limited prepared the PSURs to the highest standards which did not receive further assessment reports from the regulatory agencies.
- Case Study 14 : QC and Medical Review of PSURs (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help them as independent assessors to undertake quality check and medical review of various PSURs which included, Oncology, Pain, Anaesthetics (including Opioid products) products as a commitment to the FDA and EMA Regulatory Authorities following inspections and significant findings. Symogen Limited undertook this project and delivered it to the highest standard over a period of six weeks, which resulted in positive assessment report from regulators.
- Case Study 15 : Compliance with Vol 9A & PASS (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help set up of and being compliant with Vol 9A and PASS for their entire EU PV Office, Clinical Department and Regulatory Affairs department over a period of 6 months. Symogen Limited accomplished this project by working with the Global and European Teams from all the three departments in setting up this highly demanding and important project.
- Case Study 16 : Protocol development for PASS Studies (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help set up PASS and protocols for various PASS Studies throughout the region. This was achieved by working with cross functional teams including, Clinical, Regulatory, Pharmacovigilance and Epidemiology to set it up.
- Case Study 17 : Global NDA Submission for Oncology Product (Get More...)
Date : 02-02-2011
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 18 : Expanded Access Program for Oncology Product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help in setting up of the Expanded Access Programme (EAP) for Compassionate use for their new Oncology product in the USA and ROW including Europe and Asia. Symogen Limited worked with the sponsor team to effectively set up the entire program and started the first patient enrolment as well.
- Case Study 19 : Pre NDS Submission to Health Canada for Oncology Product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help in the Pre NDS Submission and authoring of Pharmacovigilance document to support Health Canada Submission for their Oncology drug. Symogen Limited prepared the required Pharmacovigilance documents for Health Canada submissions which resulted in positive decision for the product.
- Case Study 20 : EMA Submissions for Oncology Product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited to help in the submission and authoring of PV documents to support EMA Submissions for their Oncology product and to start the global Phase III trials. Symogen Limited helped and prepared all the required documents to support this project which resulted in positive decision by the EMA.
- Case Study 21 : Strategic Advice and set up of Pharmacovigilance (Get More...)
Date : 02-02-2011
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 22 : QPPV and Head of Drug Safety Pharmacovigilance Support (Get More...)
Date : 02-02-2011
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 23 : Preparation of Paediatric RMP for EMA Submission (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited for help with development and preparation of Paediatric RMP for submission to the EMA as part of the MAA. Symogen Limited helped prepare the entire document for this combination product that was complex over four weeks which received positive feedback.
- Case Study 24 : Retrospective Reconciliation of SAEs for Oncology product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited for help with retrospective reconciliation of cases for one of their major product from various license partners. Symogen Limited helped achieve this target within a month for the company with positive feedback.
- Case Study 25 : Development and Preparation of SDEAs (Get More...)
Date : 02-02-2011
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 26 : MHRA PV Inspections (Get More...)
Date : 02-02-2011
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 27 : Retrospective Correction of Listedness for major product (Get More...)
Date : 02-02-2011
A MNC requested Symogen Limited for help with their retrospective correction of listedness of cases for a major oncology product, prior to major launch in several countries. Symogen Limited helped them by correcting the listedness in their safety database in a very short time of seven days.