Think i- Pharmacovigilance Presentation

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Presentation Description

We at Think I are looking for potential business partners in pharmacovigilance and regulatory affairs, Our company is committed to deliver cost effective, flexible , complaint solutions to all pharmacovigilance services (Gap Analysis, Preparing SOPs & WI’ s, PSMF, Imparting PV Training, preparing SDEAs, Integrating QMS PV System, Case processing of ICSR, medical review, MedDRA coding, aggregate reporting, signal detection & risk management)

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Presentation Transcript

Your Pharmacovigilance Health Sciences Services Partner:

Your Pharmacovigilance Health Sciences Services Partner

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Overview

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YOUR COMPANY THINK I Services Safety contact centre Case Processing Data Entry Signal Detection E2B Submission Aggregate reporting Medical writing Pharmacovigilance training Medical Information ADR reporting DSUR, SUSAR, ASR PADER, PSUR/PBRER , Addendum White papers End to End PV training Safety Database Argus & AB Cube Your Pharmacovigilance Health Sciences Services Partner Take a look at our process flow Literature search MeSH search

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Corporate Facts (Contd..) Lineage : Think I is a part of the Tenet Health Edutech family, a 11 year old quality health sciences training and consulting firm which boasts of state of the art training and extensive consulting experience with the life sciences companies. Think I represents expertise, high quality, and cost-effectiveness to the users. The same vision has been translated into Think I as it has entered in health sciences services arena in 2013.

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The Think I Advantage Client-centric Engagement Model Our deep-set commitment to our clients defines how we do business, and the vast array of services we offer. We build our teams around your domain and technology requirements, offering specialized services and solutions that meet the distinct needs of your business. We believe in providing the right amount and quality of work at the right cost at the right time. Experienced Team An eminent panel which possesses superior medical knowledge and English writing skills to cater to global organizations as well as Indian organizations. The staff are pre trained at our sister organization, Think I, an internationally accredited Pharmacovigilance training organization. Entire team is GCP and GPV trained and certified. Team experienced on Oracle Argus Safety, ARISg and other proprietary safety databases.

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The Think I advantage (contd..) Quality as a way of life Think I systems, infrastructure, processes, IT are successfully audited by global auditors Data security Strong IT Systems, Servers & Processes Well secured offices – physical and electronic security – monitored 24x7 24x7 power supply and power back ups Internationally accepted, state of the art data handling systems Confidentiality agreements signed by all staff and vendors Ethics and Compliance Use of tried and tested business practices Aim to cultivate and nurture long term relationships with all our stakeholders

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Infrastructure Delhi National Capital Region (NCR) is considered the hub for education and healthcare being, equipped with the finest hospitals in Asia along with excellent health sciences and pharmaceutical educational institutions. Good pool of pharmacovigilance and clinical research professionals are available as Delhi National Capital Region has some of the best Clinical Research, Pharmacovigilance and other health sciences Institutes and Training centres in India. Presence of Regulatory Authority office (DCGI) in Delhi confers a definite advantage for pharmaceutical companies and clinical research organizations (CROs).

IT Infrastructure & Data Security:

IT Infrastructure & Data Security Strong IT Systems, Servers & Processes Well secured offices – physical and electronic security – monitored 24x7 Internal server which is firewall protected Round the clock monitoring to ensure security and maintenance Highest standards of data security measures are employed Zero risk of data loss, pilferage or unauthorised access 24x7 power supply and power back ups

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Quality Systems Think I systems, infrastructure, processes, IT are successfully audited by global auditors Internationally accepted, state of the art data handling systems Confidentiality agreements signed by all staff and vendors Think I has well defined, detailed, validated, audited SOPs on all business processes, services, IT, data security, administration, disaster management, business continuity planning.

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Pharmacovigilance Services Drug Safety Services Single case processing Aggregate Reports Literature search and Review QPPV services and Pharmacovigilance system master file MedDRA coding

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Drug Safety Services Post marketing Pharmacovigilance Clinical safety reporting Case Processing Case Processing( SAEs) Expedited reporting (ICSRs) Expedited reporting Literature screening Clinical Trial Safety PSURs Periodic reporting (ASRs) Safety Signal generation and assessment

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Drug Safety Services Case Intake Case Processing Medical Assessment Distribution/ submission Safety data Receipt Data entry Medical review Regulatory submission Duplicate check MedDRA Coding Causality assessment Ethics committee notification Triage Narrative writing Individual ICSR Signal screening Sponsor Case Tracking Reviewing cases and QC, Review case documents against source documents, Query generation and forwarding Create an analysis of similar events, Send to sponsor for 2 nd line MR, if necessary

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Drug Safety Services (Contd..) Aggregate Reporting Periodic Safety Update Reports (PSURs) Periodic Adverse Drug Experiences Report (PADERs), Development Safety Update Reports (DSURs) and Periodic Benefit Risk Evaluation Reports (PBRERs) Other Reports- Addendum reports, Summary Bridging Reports (SBRs), SUSAR Reports, Drug Safety Reports (DSRs) and Annual Safety Reports (ASRs)

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Drug Safety Services (Contd..) Preparation and development of risk management plan, RMP Preparation of Detailed Description of Pharmacovigilance System Literature Search and Review Preparation of Pharmacovigilance System Master File (PSMF) for the QPPV MedDRA coding services

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Pharmacovigilance Consulting Services Building a complete pharmacovigilance system for pharmaceutical companies and CROs QPPV/ LPVRP/LAR services in markets where it is required Preparation of SOPs and other guidance documents Writing and updating Reference Safety Information (RSIs) Pharmacovigilance audits Regulatory support and guidance Pharmacovigilance corporate training programmes

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Pharmacovigilance Consulting Services (Contd..) In addition to the services mentioned previously, we also offer the following to Indian companies wishing to enter the United States of America (USA) market Pharmacovigilance audits Inspection readiness Setting up and managing the overall drug safety infrastructure in the USA Developing Standard Operating Procedures (SOPs) for the pharmacovigilance processes

List of QPPV/LPVRP services::

List of QPPV/LPVRP services: Function as a single point of contact between the regulators and MAH Provide expertise in leading pharmacovigilance operations in the region Collecting , logging, documenting and forwarding Adverse events (AEs), Product Quality Complaints ( PQCs) and Medical Information Enquiries, as needed Communicate to Global Pharmacovigilance and facilitate the fulfillment of any local pharmacovigilance obligations as per local health regulatory requirements Forward all pharmacovigilance data to Global Pharmacovigilance and contractual partners within the prescribed timelines and filing received acknowledgements regarding this Periodic Reconciliation of AEs with Central Processing Group

List of QPPV/LPVRP services (Contd..):

List of QPPV/LPVRP services (Contd..) Sending initial responses to Adverse Event/Product complaint reporter Translation Reviewing local health authority websites at periodic intervals for updates Submission of expedited ICSRs and Aggregate reports to Regulators Co-ordination for Safety data exchange agreements between MAH and local contractors Reporting Potentially New safety information/Crisis management to Global Pharmacovigilance team Maintaining the Local Pharmacovigilance Site File and associated documentation

Pharmacovigilance System Set Up:

Pharmacovigilance System Set Up Gap Analysis, Preparing SOPs & WI’ s, PSMF, Imparting PV Training, preparing SDEAs, Integrating QMS at Bliss with the PV System Most of this information prepared, could be used for several other marekts with some minor changes

Our Packages :

Our Packages Tier 1: Case processing on client database Tier 2: Case processing and safety database of Think I Tier 3: Case processing on safety database of Think I and aggregate reporting Tier 4 : Case processing on safety database, aggregate reporting with Signal Detection and Risk management

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Corporate Training Programmes Think I certified team of trainers ensures a focus on constant training and retraining of its staff. Team Think I is rich in experience, qualification and stability. We have a good pool of well trained and certified professionals with medical, dental, life sciences and Pharmacy backgrounds.

Pharmacovigilance Training:

Pharmacovigilance Training Think I corporate pharmacovigilance programmes are designed to provide comprehensive yet cost effective training solutions to the client needs. All programmes have been prepared in consultation with industry experts and cater to the live industry scenarios. Programmes can be delivered at the client site or in an online mode. Suitable for beginners as well as mature PV companies.

Pharmacovigilance Training :

Pharmacovigilance Training 1. Understanding pharmacovigilance systems Regulations in Pharmacovigilance This section would cover international regulations and applicable local regulations as per client requirements Setting up a pharmacovigilance system Qualified Person for Pharmacovigilance (QPPV) and their importance 2. Spontaneous case processing Receipt and handling of spontaneous reports including narrative writing Expeditable and non expeditable reports Medical Evaluation Quality Checks Electronic submissions

Pharmacovigilance Training :

Pharmacovigilance Training 3. Handling study reports Introduction to clinical studies and receipt of study reports Handling solicited and clinical study reports Narrative Writing Medical review and SUSARs (SUAs) Investigator’s Brochures and their significance Blinded clinical trials- PV considerations 4 . Literature search and review Regulations, Databases, review and case entry Aggregate reporting requirements Risk Benefit Assessment

Pharmacovigilance Training :

Pharmacovigilance Training 5. Aggregate Reports Roles and responsibilities Types of aggregate reports Content and format Quality control and distribution 6. Signal detection, assessment and risk management plans General considerations Sources of signals Detection and assessment Risk assessment and minimization

Pharmacovigilance Training :

Pharmacovigilance Training 7. Guidance documents in Pharmacovigilance Types of guidance documents Importance and scope of SOPs and WI’s 8. Reference Safety Information Types of RSIs Role and Importance Review of and updating RSIs 9 . Pharmacovigilance Audits and Inspections Introduction and relevant guidance Audit preparations Audit findings and CAPA

Safety database solutions:

Safety database solutions Think I partners with AB- Cube Solutions –France AB Cube provides cloud based software solutions for vigilance in Human Drugs, Medical Devices, Cosmetics, Nutraceuticals and veterinary products. Cost effective User friendly F ully validated for quick, easy import, entry and electronic submissions of adverse events.

Key features of our safety solution :

Key features of our safety solution Unlimited number of users with one time implementation cost. Safety solutions are FDA 21CFR part 11, E2B (R3), HL7 compliant Validated according to GAMP 5 (Good automated manufacturing practices), full validation dossier provided. Safety solutions are FDA 21CFR part 11, E2B (R3), HL7 compliant Generation of PBRER and Signal Detection. Extensive support 24/7 & Training on database through e- learning, virtual and Face to Face

Licence : 4 packages = 4 levels of Services:

Licence : 4 packages = 4 levels of Services BASIC PROFESSIONAL BUSINESS ENTERPRISE Software Functionalities Full Functionalities Unlimited number of users Standard Validation Dossier Online Access to documents Free upgrades for latest functionalities & compliance Healthcare Certified Hosting (HADS) Technical support & user assistance Support Through Tickets Monday – Friday 9:am-6:pm Monday – Friday 9:am-6:pm 7/7 9:am-6:pm 7/7 24/24 Support by phone Max. number of Key users 1 2 3 5 Answer time 5H 4H 3H 2H Included Options quoted on demand

Implementation & Training:

Implementation & Training BASIC PROFESSIONAL BUSINESS ENTERPRISE Implementation Same price BASIC PROFESSIONAL BUSINESS ENTERPRISE Training eLearning Virtual Face to Face Included Options quoted on demand  The Implementation cost remains the same regardless of the level of service chosen

Additional available options:

Additional available options BASIC PROFESSIONAL BUSINESS ENTERPRISE Gateway Provider Audit Migration Validation assistance Specific Development Set up Assistance Inspection preparation or assistance Installation On-Premise Options quoted on demand  Different options are available depending on the level of service chosen

Argus safety :

Argus safety We are also official license partner for Argus Safety and we provide database for carrying out pharmacovigilance activities in: Case Entry / Book In / Case Triaging Data Entry Medical Review Aggregate reporting (Line Listings , Summary tabulations)

The Leadership Team:

The Leadership Team Our leadership team consists of experts from the field of pharmacovigilance, clinical data management, clinical operations and corporate training. Total 100+ man years of combined experience in their fields of expertise. Capability to perform tasks from our site as well as client site. Think I is led by an impressive group of executives with hands-on expertise in safety, medical and regulatory affairs, and project governance. All have experience in guiding global organizations to function as a unified team.

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Our Values Quality We ensure quality in our processes, data integrity and excellence of deliverables. Customer Focus Our team at Think I are dedicated to satisfying the needs of our customers. We believe in creating and sustaining global standards of service that gains us customer trust and confidence.

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Our Values (Contd..) Knowledge We are always open to learn, unlearn and re learn from all sources. Knowledge sharing is important to us and is encouraged . Commitment Our primary commitment is to our clients and to our Employees and Clients and we aspire to cater to the highest of their expectations.

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Our Values (Contd..) Trust The cornerstones of our business are honesty and integrity. Thus, we aim to cultivate and nurture long term relationships with all our stakeholders. Continuous improvement We believe in continuous improvement of our technologies, procedures and the results we deliver to our customers.

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VISION Our Team has DEDICATION EXPERTISE CONTINUITY QUALITY

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It would be our pleasure to hear from you Business Development Think I C-101, First Floor Sector 2 NOIDA 201301 India Email : bd@thinki.in Website : www.thinki.in Phone : +91 98100 68241

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