Safety Simplified TERZETTO PHARMA METRICS PVT. LTD., Contact Safety Organisation

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1 Safety Simpified TERZETTO PHARMA METRICS PVT. LTD., Contact Safety Organisation

2

3 Specific soutions to monitor the safety of the drugs a over the gobe About us We provide specific soutions to monitor the safety of drugs and meet safety reguatory requirements for cients across the gobe. Located in the garden city of Bangaore, Terzetto Pharma Metrics Pvt. Ltd. is headed by eading experts in pharmacovigiance, risk based monitoring and audit. Hence the interna standards deveoped are time tested and backed by strong reguatory and operationa experience. Our safety surveiance services are supported by strong scientific methods coaborated with vaidated medica anaysis. Our team has work experience over a wide range of drugs beonging to traditiona medicines, bood products, bioogica products and medica devices and vaccines. Pharmacovigiance Software Soutions Auditing Reguatory Consutations Risk Management Risk Based Monitoring

4 Mission Statement To promote better safety surveiance for human & veterinary products To provide reasonabe safety information to heathcare professionas To contribute safety information of the products via signa detection To concentrate efforts on areas of medicina safety during disastrous times To support sma and medium sized companies with fair price poicy To constanty support better patient care across the gobe To be a good corporate citizen in safety reporting To foster individua growth within our organisation

5 Quaity Poicy To work on systems that constanty monitor and nurture safety of medicina products To promote appropriate sharing of safety information To work on a goba scae to prevent injuries reated to use of medicina products To design, impement and anayse risk management for products To work aong with our cients in crisis management To work with accurate information on a the stages of safety data handing To work aong with various heath care providers in coection of safety information To design systems and constanty monitor safety through identifying, evauating, managing and minimising safety issues of our cient's products Constanty work on educating various stake hoders in pharmacovigiance

6 PHARMACOVIGILANCE SERVICES Pharmacovigiance Service - Marketing Authorisation Hoders in EU Marketing authorisation hoder (MAH) is responsibe for the quaity, efficacy and safety of medicina products. Our expertise are in the area of monitoring the risk via the risk management system. We provide scientific updates on the product and communicate resuts of changes in the risk benefit ratio to heath care industry. We provide service reated to Risk management pan Creation of goba safety data capturing systems Pharmacovigiance System Master Fie Submission in Eudra vigiance Pre and post audit support Required trained manpower and EU QPPV Compete management of MAH obigation for PVG For product under monitoring - periodic safety update reports Core product safety data Handing and information processing of individua case safety reports Monitor the safety during the cinica tria phase Eectronic reporting setups Device vigiance incuding monitoring, reconciiation and report preparation Creation and distribution of Fied Safety Notices Provide pharmacovigiance awareness training for EU based pharmaceuticas Product registration on the European product database In preparing responses for reguatory communications

7 PHARMACOVIGILANCE SERVICES Pharmacovigiance Service - For Indian Pharmaceutica Cients To work aong with Indian manufacturers on drugs incuding bioogica and bood products in the area of Coection of suspected adverse drug reaction For product under monitoring - periodic safety update reports Handing and information processing of individua case safety reports Monitor the safety during the cinica tria phase Adequate measure to ensure internationa compiance Interim and annua safety reports Pharmacovigiance Service - Service For US Markets For US based cient we provide compete system and support to compy with post marketing reporting of adverse drug experiences. Spontaneous reporting Reguatory dictionary coding A aspects of management of MedWatch forms Processing of ICSR and PSURs Signa detection Medica Review of individua cases and safety narration Compete safety monitoring support for phase studies Therapeutic Area Experience

8 RISK MANAGEMENT RISK MONITORING FOR CLINICAL TRIALS Risk Based Monitoring for Cinica Trias It recommends the appropriate methods by which the sponsor can monitor the investigationa studies and oversee the conduct of and reporting of data from cinica investigations, incuding appropriate CI supervision of study site staff and third party contractors. Monitoring activities incude: Communication with the CI and study site staff, Review of the study site staff's processes, procedures, and records Third party vaidation and monitoring of cinica trias Effective monitoring of compicated cinica trias which invoves high end study design It aso monitors cinica trias that invove combinations of product ike drugs, bioogica products, vaccines and medica devices. Phase 2 and Phase 3 RBM For High End Cinica Studies Third party monitoring heps to provide accurate monitoring which affects 20% of the study data evauations. This service heps the sponsor identify critica data and processes for inaccuracy, non-performance or incorrect performance to enhance the protection of subjects invoved and the integrity of the study resuts. Remote Monitoring (RM) Centraized Monitoring is a remote evauation carried out by sponsor personne (e.g. cinica monitors, data management personne, or statisticians) at a ocation other than the sites at which the cinica investigation is being conducted. Centraized monitoring processes can provide many of the capabiities of on-site monitoring as we as additiona capabiities.

9 AUDITING SERVICES Pharmacovigance and Audit Systems Keeping in mind the EU and FDA submissions, we have strong audit protoco deveoped by in-house expertise for monitoring pharmacovigiance processes to the compiance of EU/ICH/ USFDA in the areas of medicine, medica devices and cosmetics. We deveop systems to trace and detect subpar medicines and generate reports on the same, anayse medication errors and inefficiency of marketed products, off abe use of medication in paediatric circes, individua cases of poisoning, assessment of mortaity and interaction with other marketed medicina and non-medicina products. Auditing Methodoogy Audit services encompass systematic and independent checks with regards to safety data and operations based on industry specific norms that are reguated by government bodies. The outcome of a product depends mainy on execution with accurate and correct recording in initia design and research state. We provide expert services to meet the auditing environment demands incuding GAP, GMP, GLP, GCP, GCDM, GVP and GRP whie incorporating proper time management and dedication to cient goas. We aim to maintain professiona independence and hence are not connected to any CRO services in India. Each audit process has specified approaches which enhance the adherence and compiance of the projects assigned. We provide consuting services for your reguatory requirements.

10 AUDITING SERVICES Quaity assurance division provides severa audit services to its cients. They are isted beow with corresponding reguatory status: Auditing Services - Types 21 CFR Part 11 Software soutions EU Submission in Euvigi via EV web/ Process and approvas EU For Indian MAH- compete service and support system EU EU QPPV provision & nationa Qps EU Product registration on the European product database EU PSMF / Pre audit and Post Audit / QPVP ICH Safety soution for cients conducting Phase trias ICH Auditing - performance monitoring periodic/annua ICH Vaidation of System capturing PVG data ICH Deveopment of RMP/ monitoring for accuracy ICH Goba project management for PVG requirement ICH Goba expedited case reporting / Eectronic reporting setup Monitoring process for report generation Goba iterature search and review Quaity monitoring, system impementation and assurance Training & awareness eve/compiance check Periodic reporting, incuding PSURs and safety reviews A aspects of Individua Case Safety Report(ICSR) Integrated summaries of safety Compete pharmacovigiance activity across the goba 24/7/365 coverage data coection process monitoring Preparatory Case narratives/signa detection using sponsors software Preparatory Preparation the first time submission for pre- audit Preparatory Managing reguatory audit US FDA Compiance monitoring for 21 CFR 11,210, 211,310,312,314, US FDA Compiance monitoring for 21 CFR 600,822 US FDA Process of management of 483

11 SCIENTIFIC SERVICES & SOFTWARE SOLUTION Scientific Services Scientific Services are used to measure the benefits, effectiveness and adverse effects of drugs used and encourage their safe, rationa and effective data coection, scientific evauation and medica writing. A the services compy with quaity standards reated to pharmacovigiance systems. Aready Marketed Products For products that are aready marketed, the services incude risk management pan and management in compiance with EU requirements, management of PMF, post market signaing with the provision of a required information for compiance with EU requirements. For Indian Marketing Authorization Hoders Drug manufacturer require PV monitoring compying with part of the reguatory requirement. Keeping in mind EU and FDA submission cients has ed us to create divisions to process EU specific Individua case reports sessions. The Indian Drugs and Cosmetics Act's requirement of periodic reporting is carried out by the same division which is an added advantage for the team to work on the marketed product. We deveop systems to trace and detect subpar medicines and generate reports on the same, anayze medication errors, anayze the inefficiency of marketed products, to detect off abe use of medication in pediatric popuation, individua cases of poisoning, assessment of mortaity and interaction with other marketed medicina and nonmedicina products. Software Soutions The SMS based mode is used to improve patient care and safety with regard to: The usage of medicines Tracking of iega sae of medicines and drug abuse through onine means Prevention of potentiay unsafe drug donation practices Prevention of manufacture and sae of counterfeit and substandard medicines Onine Software is used to track the safety of medicina products

12 Reguatory Information Management Experience in goba pharmaceutica reguatory and presence of quaity assurance expertise enabes Terzetto team to provide RIMS service. The regiona management and system impementation wi be on the foowing steps: 1) Resource training - under goba coaching principes 2) Software patform and connectivity estabishment 3) Preparation on vaidation of the software 4) Coection of data at a specific time frame point/contractua obigation 5) Goba inference of the safety data 6) Fie formats 7) Submission of Reports (pubishing, cinica report, abeing specification) 8) Audit management 9) Preparation of the PSUR, ICSR and submission 10) 510K fiing

13 NOTES

14 NOTES

15

16 Contact Us Terzetto Pharma Metrics Private Limited Contract Safety Organisation No. 142/2, 2nd Cross, Munnireddy Layout, Horamavu, Bangaore Teephone , Emai :

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