Think I- Delivering cost effective & complaint pharmacovigilance

1. Your Pharmacovigilance Health Sciences Services Partner

2. Overview

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

4. 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 Ias it has entered in health sciences services arena in 2013.

5. The Think IAdvantage • 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.

6. The Think Iadvantage (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

7. 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).

8. 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

9. 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.

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

11. Drug Safety Services

12. Drug Safety Services

13. 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)

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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.

22. Pharmacovigilance Training • Think Icorporate 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.

23. 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

24. 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

25. 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

26. Pharmacovigilance Training 7. Guidance documents in Pharmacovigilance • Types of guidance documents • Importance and scope of SOPs and WI’s 8. ReferenceSafety 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

27. 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 • Fully validated for quick, easy import, entry and electronic submissions of adverse events.

28. 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 • Safety solutions are FDA 21CFR part 11, E2B (R3), HL7 compliant • Validated according to GAMP 5 (Good automated manufacturing practices), full validation dossier provided. • Generation of PBRER and Signal Detection. • Extensive support 24/7 & Training on database through e- learning, virtual and Face to Face

29. Licence : 4 packages = 4 levels of Services Included Options quoted on demand

30. Implementation & Training  The Implementation cost remains the same regardless of the level of service chosen Options quoted on demand Included

31. Additional available options Options quoted on demand  Different options are available depending on the level of service chosen

32. 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)

33. 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.

34. 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.

35. 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.

36. 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.

37. VISION Our Team has DEDICATION QUALITY EXPERTISE CONTINUITY

38. 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