DIA India Medical Devices Conference 2020 Strategies for the Medtech Revolution 21-22 February | Leela Ambience Convention Hotel, New Delhi, India

DIA India Medical Devices Conference 2020 Strategies for the MedTech Revolution 21-22 February | Leela Ambience Convention Hotel, New Delhi, India

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PROGRAM COMMITTEE Over the past decade, there has been an acceleration in the development of new medical devices and these new product innovations stem from the discovery of an Vinay Rajan unmet patient need to better monitor and manage their health, aid providers in Regional Clinical Leader improving care delivery, or devices that enable better treatment administration. Indian Subcontinent Medtronic Navigating medical device design and development is a complex process with regulations, specifications, application requirements, and patient needs. With this Sudhakar Mairpadi program, DIA India is creating a platform to discuss the process of developing a medical Head – Quality, Regulatory device right through concept feasibility, design validation preclinical research, clinical and Government Affairs, development, market approval and post approval marketing as well as deliberate upon Philips the various factors influencing development strategy including regulations, evolving end user needs, technology innovations and the need for product differentiation.

Bina Naik Objective Chief Operating Officer With this program, our goal is to look deeper into the challenges and opportunities in CBCC Global design and development of medical devices and creation of strategies that enhance probability of a successful market launch, balancing technology advancements with end user needs, navigating major regulatory pathways, compliance and design control needs Saikat Biswas for devices, effective preclinical, clinical and PMS planning and execution. Head, Medical Devices Pharma and Services Wipro Key topics for the event and expected participation: Key Focus Areas Ashish Indani • The Impact of MDRs and The Way Forward for Medical Devices in India Domain Consultant • Application of Latest Technologies in Device Design Development Life Sciences ADD • Determining Preclinical Development Needs: Mechanical, Animal and Biocompatibility Platforms & Medical Studies (ISO 10993) Devices • Clinical Evaluation and Investigation for Devices Tata Consultancy Services • Implementing Iso 13485, MedDev 2.12.2 And 21 CFR 820 / 803 Requirements • Use of Medical Device in An Off-Label Indication - Boon in Disguise? Anish Desai • Health Economics and Health Technology Assessment in Medical Device Environment Director IntelliMed Healthcare Key Functions and Departments Participating: Solutions • Device development professionals • Regulatory affairs Sundeep Agarwal • Clinical development General Manager • Quality affairs Compliance & Regulatory • Compliance and testing professionals Affairs • Design and development consultants Datt Mediproducts Pvt Ltd • General management • PMS experts for devices

Lipi Chakairyar Head- Regulatory Affairs Indian Subcontinent Medtronic

Priyadarshini Arambam General Manager - Clinical Research Operations Academics & Research For further information, please reach out to: Department Niveda Ramkumar Batra Hospital and Medical +91 9620372878 | [email protected] Research Centre

8.00 – 9.00 Registration

9.00 – 9.30 Opening Ceremony

09.30 - 10.15 Key note Presentation | STRENGTHENING MEDICAL DEVICE REGULATIONS IN INDIA- THE WAY FORWARD

V.G. Somani Drug Controller General of India (DCGI) CDSCO

10.15 - 11.00 Tea / Coffee Break

Session # 1 Navigating Medical Device Regulations

Session Chair | Saikat Biswas Global Head – Medical Devices, Pharma & Services, Digital Operations & Platforms, Wipro

11.00 – 11.30 CURRENT REGULATORY TRENDS IN MEDICAL DEVICE DEVELOPMENT – NAVIGATING DEVICE SPECIFIC ISO REGULATIONS

Sushant Senapaty Senior Manager - Regulatory Services Practice Digital Operations and Platforms Wipro

11.30 – 12.00 HOW TO CLASSIFY YOUR NEW DEVICE FOR US, EU AND GHTF AFTER EU MDR2017 (EU) AND MDR 2017 (INDIA)?

Latika Vats Director Regulatory and Quality Assurance Medtronic

12.00 – 13.00 EVOLVING DEVICE REGULATIONS- ENSURING COMPLIANCE, QUALITY AND PATIENT SAFETY

Moderator Saikat Biswas Global Head – Medical Devices, Pharma & Services, Digital Operations & Platforms, Wipro

Panelists Shalabh Srivastava Sudhakar Mairpadi A Ganesh Kumar Milind Antani Praveen Kumar L Head of Quality Head- Quality Head – Quality & Lead - Pharma & Director - Regulatory Enterprise Regulatory & Govt Regulatory Affairs Healthcare Affairs and Wipro Digital Affairs (India Zone) Medical Device & Head-Devices Operations and Philips Siemens Healthineers Med-Tech Practice Cipla Ltd. Platforms Nishith Desai Associates

13.00 – 14.00 Networking Lunch AGENDA | DAY 1 | 21st February, 2020

Session # 2 – Enhancing Device Safety Through Improved Materiovigilance Practices

Session Chair | Lipi Chakhaiyar Head - Regulatory Affairs Indian Subcontinent, Medtronic

14.00 – 14.30 OVERVIEW OF MEDICAL DEVICE SAFETY SURVEILLANCE SYSTEM IN INDIA

Vivekanandan Kalaiselvan Principal Scientific Officer Indian Pharmacopoeia Commission

14.30 – 14.50 PSUR AND REGULATORY REPORTING REQUIREMENT AS PER MDR AND PSUR MANAGEMENT

CDSCO Representative – TBC

14.50 – 15.10 SAFETY REPORTING CHALLENGES: PERSPECTIVE FROM REGIONAL SAFETY MONITORING CENTRE

Harmeet Rehan Professor & Head, Lady Hardinge Medical College

15.10 – 16.00 OPEN FORUM DISCUSSION: USE OF MEDICAL DEVICE IN AN OFF-LABEL INDICATION - BOON IN DISGUISE?

Moderator Lipi Chakairyar Head, Regulatory Affairs, Indian Subcontinent, Medtronic Panelists V. Kalaiselvan Rahul Chauhan Latika Vats Sahjogita Kathuria Principal Scientific Officer Director Director- Regulatory Director RA & QA Indian Pharmacopoeia Regulatory and Medical and Quality Assurance Terumo Commission Affairs- South Asia Medtronic Reckitt Benckiser 16.00 – 16.15 Tea / Coffee Break

Session# 3 – Emerging Preclinical and Translational Paradigms for Devices

Session Chair | Sudhakar Mairpadi Head- Quality, Regulatory and Govt Affairs, Philips

16.15 – 16.45 CONCEPT VALIDATION, DESIGN FEASIBILITY AND IMPORTANCE OF BUILDING IN END USER NEEDS THROUGHOUT THE DEVELOPMENT CYCLE

Rupam Choudhury Global Industry Vertical Head, Tata Consultancy Services

16.45 – 17.15 DETERMINING PRECLINICAL DEVELOPEMENT NEEDS: MECHANICAL, ANIMAL AND BIOCOMPATIBILITY STUDIES (ISO 10993)

A Ganesh Kumar Head – Quality & Regulatory Affairs (India Zone), Siemens Healthineers AGENDA | DAY 2 | 22nd February, 2020

Session # 4 – Effective Clinical Investigation and Evaluation Strategies

Session Chair | Bina Naik Chief Operating Officer, CBCC Global

09.00 – 09.30 CLINICAL INVESTIGATIONS OF MEDICAL DEVICES – TYPES OF STUDIES, STUDY DESIGNS, VARIOUS CONTROLS AND A BRIEF REFERENCE TO ISO 14155

Sindhu John Manager - Clinical operations, South Asia Medtronic

09.30 - 10.00 CLINICAL EVALUATION OF MEDICAL DEVICES

Milind Antani Lead - Pharma & Healthcare Medical Device & Med-Tech Practice Nishith Desai Associates

10.00 - 10.30 POST MARKET FOLLOW UP STUDIES - REQUIREMENTS AND IMPLEMENTATION

Sumit Anand Associate Director - Clinical Operations Abbott

10.30 - 11.00 Tea / Coffee Break

Session# 5 –Emerging Trends in Clinical Development of Devices

Session Chair | Priyadarshini Arambam General Manager - Clinical Research Operations-Academics & Research Department Batra Hospital and Medical Research Centre

11.00 – 11.30 ROLE OF TECHNOLOGY IN DEVICE DESIGN AND DEVELOPMENT

Sundeep Agarwal General Manager, Compliance and Regulatory Affairs, Datt Mediproducts Pvt Ltd.

11.30 – 12.00 SYNCHRONIZING CLINICAL DEVELOPMENT STRATEGY WITH TECHNOLOGY INNOVATIONS IN MEDICAL DEVICES

Jayesh Jani Strategic Medical Affairs and Professional Education Director ConvaTec

12.00 – 12.30 CLINICAL DEVELOPMENT CHALLENGES FOR NEXT GENERATION MEDICAL DEVICES- INVESTIGATOR’S PERSPECTIVE

Upendra Kaul Chairman Batra Heart Centre and Dean Academics and Research

12.30 – 13.00 PANEL DISCUSSION | CLINICAL DEVELOPMENTSTRATEGIES FOR NEW AGE DEVICES- WHAT LIES AHEAD?

Moderator Priyadarshini Arambam General Manager - Clinical Research Operations, Academics & Research Department Batra Hospital and Medical Research Centre

Panelists Jayesh Jani Upendra Kaul Sundeep Agarwal Manish Narang Saurabh Kumar Strategic Medical Chairman General Manager Senior Medical Advisor Director Affairs and Batra Heart Centre Compliance and Asia Pacific & Japan HEOR - Scientific Services Professional and Dean Academics Regulatory Affairs Abbott Vascular IQVIA Education Director and Research Datt Mediproducts ConvaTec Pvt Ltd.

13.00 - 14.00 Networking Lunch AGENDA | DAY 2 | 22nd February, 2020

SESSION # 6 – Emerging Trends in Medical Device Marketing Authorization and Commercialization

Session Chair | Anish Desai Director, IntelliMed Healthcare Solutions (A division of Pharmaserv Solutions)

14.00 – 14.30 HEALTH ECONOMICS AND HEALTH TECHNOLOGY ASSESSMENT IN MEDICAL DEVICE ENVIRONMENT

Vibhav Garg Director, Health Economics & Govt Affairs India HUB & ASEAN, Boston Scientific

14.30 – 15.00 LEVERAGING HEALTH TECHNOLOGY ASSESSMENT IN CREATING PRICING STRATEGIES FOR INDIA

Pinaki Ghosh Manager - Pharmacoeconomics, HTA and Market Access, BBraun

15.00 – 15.30 Tea/Coffee Break

Session# 7 – Shaping The Future of Medical Devices in India

Session Chair | Ashish Indani Domain Consultant- Life Sciences ADD Platforms & Medical Devices, Tata Consultancy Services

15.30 – 15.45 GENERATION AND UTILITY OF UNIQUE DEVICE IDENTIFICATION (UDI)

Utsav Dave Senior Engineer, Tata Elxsi

15.45 – 16.00 BIG DATA AND AI IN COMPLIANCE AND REGULATION

Bhavish Agarwal Co-founder, Dhan AI

16.00 – 16.45 PANEL DISCUSSION: EXECUTIVE PERSPECTIVES ON THE FUTURE OF MEDICAL DEVICES IN INDIA

Ashish Indani Domain Consultant, Life Sciences ADD Platforms & Medical Devices, Tata Consultancy Services Panelists Rachna Malik Preeti Wani Anish Desai Sumit Anand Rahul Rathod Global Head - Advanced Plant Head Director Associate Director Medical Affairs Drug Development (Medical Devices) IntelliMed Healthcare Clinical Operations Cluster Head Platforms (ADD) Sahajanand Laser Solutions Abbott Dr. Reddy’s Laboratories -Life Sciences Technology Ltd (A division of Tata Consultancy (SLTL) Pharmaserv Services Solutions)

16.45 – 17.00 SUMMARY OF KEY FINDINGS- TAKE AWAYS FROM DIA MEDICAL DEVICES CONFERENCE 2020

Ashish Indani Domain Consultant, Life Sciences ADD Platforms & Medical Devices, Tata Consultancy Services

17.00 Closing Remarks DIA India Medical Devices Conference 2020 - Strategies for the MedTech Revolution Event I.D. 20655 | 21-22 February 2020 | India

VENUE: THE LEELA AMBIENCE CONVENTION HOTEL, DELHI CANCELLATION POLICY: ON OR BEFORE 31ST JANUARY 2020 1 CBD, MAHARAJA SURAJMAL ROAD, NEAR YAMUNA SPORTS COMPLEX, • Cancellations must be in writing and received by 31st January 2020 DELHI -110032, INDIA • Registrants who do not cancel in writing by that date and do not attend T: +91 (11) 71721234 F: +91 (11) 71721235 the event will be responsible for the full registration fee paid. Registrants CONTACT PERSON: MONICA BHAGAT : M: +91 - 8130990843 are responsible for cancelling their own hotel and airline reservations. MEETING MANAGER: • DIA reserves the right to alter the venue, if necessary. If an event is NIVEDA RAMKUMAR cancelled, DIA is not responsible for any airfare, hotel or other costs Associate Director - Scientific Programs and Development incurred by registrants. DIA (India) Private Limited • UPON CANCELLATION, the administrative fee that will be withheld from cell: +91 9620372878 | [email protected] refund amount is 25 % of the delegate fee Kanchan Patel FULL MEETING CANCELLATION Associate Director - India Operations • All refunds will be issued in the currency of the original payment DIA (India) Private Limited cell: +91 90.2909.8844 | [email protected] Online registrations: visit our website www.diaglobal.org

REGISTRATION FEES FOR TWO DAYS CONFERENCE (Registration fee includes refreshment breaks and luncheons.)

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