Welcome & Introduction

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3 08:00 09:00: Registration 09:00 10:00: Welcome & Inauguration Day 1 Saturday, 29 June 2013 ROYAL ROOM Dr. Naresh Trehan, Chairman and Managing Director, Medanta The Medicity, India Dr. Ranjit Roy Choudhary, Chairman, Task Force for Research, Apollo Hospitals Educational and Research Foundation, New Delhi and National Professor of Pharmacology, India Dr. Robert Califf, Vice Chancellor Director, Duke Translational Medicine Institute, USA Prof. Nirmal Kumar Ganguly, Biotechnology Research Professor, National Institute of Immunology, India Dr. Marjorie A. Speers, President and CEO, Association for the Accreditation of Human Research Protection Programs Inc., USA Mr. Aijaz Tobaccowalla, Managing Director - Pfizer Limited, India 10:00 11:00: Implementation of New Indian Regulations for Protection of Research Participants: Insurance and Compensation Moderator: Dr. YK Gupta, Professor & Head, Department of Pharmacology, All India Institute of Medical Sciences, India Dr. Mubarak Naqvi, Senior Director CSU, Sanofi India Limited, India Mr. BT Kaul, Associate Professor, Faculty of Law, University of Delhi, India TBD Insurance Company Dr. Ranjit Roy Choudhary, Chairman, Task Force for Research, Apollo Hospitals Educational and Research Foundation, New Delhi and National Professor of Pharmacology, India Mr. Alishan Naqvee, Partner at LexCounsel, Law Offices, India 11:00 11:30: Tea/Coffee and Networking 11:30 12:30: Spotlight on Ethics Committee role for Protection of Research Participants Moderator: Dr. Nalin Mehta, Member, AIIMS Ethics Committee, India Welcome & Introduction Session Theme: Impact & Implementation of New Regulations Dr. Nandini Kumar, Former Deputy Director General Sr. Grade (ICMR),India Dr. Urmila Thatte, Professor and Head, Dept. of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, India

4 Mr. Solomon Yimam, Assistant Country Director (Clinical Research) U.S. FDA India Office, India Dr. Robert Califf, Vice Chancellor Director, Duke Translational Medicine Institute, USA TBD, Biopharma Industry Professional Session Theme: Patients First Focus of Human Research Protection 12:30 13:30: Introducing The Concept of Human Research Protection Program: Different Stakeholders, Different Perspectives Moderators: Dr. Nagendra Swamy S.C, President - MHE & Chairman- Quality Council, MHE, India Dr. Marjorie A. Speers, President and CEO of AAHRPP,USA Dr. Mohanish Anand, Senior Director, Global Investigator Site Strategy, Pfizer Inc., USA TBD, Academia Dr. Nandini Kumar, Former Deputy Director General Sr. Grade (ICMR), India Ms. Sameena Maldar, Community Member, National Institute of Research in Reproductive Health Ethics Committee, India 13:30 14:30: Lunch 14:30 15:30: Patients First: The Focus Of Human Research Protection Program Moderators: Ms. Mohuya Choudry, Journalist and Clinical Research Reporter, India Dr. Felix Khin-Maung-Gyi, CEO, Chesapeake Research Review, Inc., USA Ms. Bridgitte Attwood, Sr. Director, Global Clinical Trial Development & Support Lead, Pfizer Inc USA Ms. Meeraben Shah, Lay Member of Ethics Committee / Founder member PARTAKE, India Dr. Nalin Mehta, Member, AIIMS Ethics Committee, India Dr. Sanjay Mittal, Director - Research and Clinical Cardiology, Medanta - The Medicity, India 15:30 16:00: Tea/Coffee and Networking Session Theme: Quality, Compliance & Public Perception 16:00 17:00: Quality Matters : Improving The Protection of Research Subjects and Providing Public Assurance Moderators: Dr. Surinder Kher, Chief Executive Officer- Asia at Manipal Acunova Limited, India Dr. Bairy Laxminarayana K, Director, Manipal Centre for Clinical Research, Manipal, India Mr. Pathik Divate, CEO, Jehangir Clinical Development Center (JCDC), India

5 Dr. Chandrika Arora, Former Senior Director & Head Clinical Operations - Quintiles (India) Dr. Chandrashekhar Potkar, Director, Medical & Regulatory Affairs, Pfizer Limited, India Dr. Sanjay Mittal, Director Clinical Cardiology & Research, Medanta-The Medicity, India 17:00 17:30: Compliance In Clinical Research And Impact On Public Perception Of Clinical Trials Speaker: Dr. Tal Burt, Scientific Director, Duke Global Proof-of-Concept, Research Network, USA Dr. Arun Bhatt, President, Clininvent Research Pvt. Ltd., India Day 2 Sunday, 30 June 2013 ROYAL ROOM I Conducted By: Association for the Accreditation of Human Research Protection Programs, Inc. Session Theme: Seeking AAHRPP Accreditation 9:00 9:30: Introduction to AAHRPP Accreditation Philosophy and Process Speaker: Dr. Marjorie A. Speers, President and CEO of AAHRPP, USA 9:30 10:30: Overview of the Accreditation Standards (Speers) Speaker: Dr. Marjorie A. Speers, President and CEO of AAHRPP, USA 10:30 11:00: Tea/Coffee and Networking 11:00 11:30: Building a Human Research Protection Program Speaker: Dr. Bairy Laxminarayana K, Director, Manipal Centre for Clinical Research, Manipal, India 11:30 12:00: How to Conduct a Self-Assessment Speaker: Mrs. Neelambari Bhosale, Head Quality Assurance, Jehangir Clinical Development Center Pvt. Ltd., India 12:00 13:00: Education, About and Implementation of HRPP Speaker: Dr. Pratibha Pereira, HRPP Consultant, India 13:00 14:00: Lunch

6 Day 2 Sunday, 30 June 2013 ROYAL ROOM II Conducted By: Public Awareness of Research for Therapeutic Advancements through Knowledge & Empowerment Society 9:00 9:15: Conception and Goals of PARTAKE Speaker: Dr. Nandini Kumar, Former Deputy Director General Sr. Grade (ICMR), India 9:15 9:30: PARTAKE Governance Optimal Structuring of a Multi-stakeholder Public Awareness Organization Speaker: Dr. YK Gupta, Professor & Head, Department of Pharmacology, All India Institute of Medical Sciences, India 9:30 10:30: Need and Role for the PARTAKE Initiative in India s Clinical Research Environment General Discussion Ms. Poonam Bagai, Founder Chairman at Cankids...KidsCan Dr. Tal Burt, Scientific Director, Duke Global Proof-of-Concept, Research Network, USA Dr. Pooja Sharma, Senior Scientist, Medanta The Medicity, India Dr. Surinder Kher, Chief Executive Officer- Asia at Manipal Acunova Limited, India 10:30 11:00: Tea/Coffee and Networking 11:00 11:15: Challenges Facing a Multi-stakeholder Clinical Research Environment Speaker: Dr. Naresh Trehan, Chairman and Managing Director, Medanta The Medicity, India 11:15 11:30: Role and Perspective of Media on Challenges Facing Multi-stakeholder Initiatives Speaker: Ms. Gauri Kamath, Journalist, India 11:30 13:00: Optimal Way Going Forward for the PARTAKE Initiative: Concrete Solutions to Perceived Challenges Panel Discussion Dr. Mubarak Naqvi, Senior Director CSU, Sanofi India Limited, India Dr. Anil Seth, Director, Clinical Operations, Eli Lilly & Co India Pvt. Ltd., India Dr. Nalin Mehta, Member, AIIMS Ethics Committee, India 13:00 14:00: Lunch Session Theme: Public Perception

7 Day 2 Sunday, 30 June 2013 BOARD ROOM LOUNGE Conducted By: Indian Society for Clinical Research Session Theme: Ethics in India: Expanding Horizons 9:30 10:30: Expanding EC roles: Are we biting more than we can chew? - Debate Proposition Dr. Vishwas Sovani, Country Manager, Revogenex Inc., India Opposition Dr. Ravindra Ghooi, Chairman, Jehangir Institutional Review Board, India 10:30 11:00: Tea/Coffee and Networking 11:00 12:00: How to make the consent process in India more robust, include discussion on Video consent Moderators: Dr. Arun Bhatt, President, Clininvent Research Pvt. Ltd., India Dr. Sanjeev Sinha, Consultant Physician, Additional Professor, Department of Medicine, AIIMS, India Dr. Preethi Shivayogi, Chairperson, Lifeline Ethics Committee, India Mr. Alishan Naqvee, Partner at LexCounsel, Law Offices, India 12:00 13:00: Active role of Ethics Committees in driving Ethical Research in India Ms. Preethi Shivayogi Chairperson, Lifeline Ethics Committee, India Dr. Anirban Roychowdhury, Senior Director-Global Clinical Trial Operations, MSD Pharmaceuticals Pvt. Ltd., India 13:00 14:00: Lunch Day 2 Sunday, 30 June 2013 ROYAL ROOM Combined Sessions by AAHRPP, PARTAKE, ISCR 14:00 15:30: Summary of the breakout sessions and outcomes followed by audience discussion Speaker: AAHRPP, PARTAKE & ISCR 15:30 16:00: Vote of thanks - MDRI & Medanta 16:00 16:30: Tea/Coffee and Networking

8 CONFERENCE INFORMATION ORGANIZERS: Patron: Dr. Naresh Trehan, Chairman & Managing Director, Medanta The Medicity Organizing Chairman: Dr. Sanjay Mittal, Director Clinical Cardiology & Research, Medanta -The Medicity Organizing Secretary: Mr. Sachin Shedge, Director Business Development, Medanta Duke Research Institute Organizing Committee: Dr. Pooja Sharma, Dr. Mukul Manchanda, Dr. Mehmood Azim, Mr. Rajiv Misra Mr. Md Muneeb Ahsan, Mr. Santhosh Joseph CONFERENCE VENUE: The Leela Kempinski Gurgaon Ambience Island, National Highway 8 Gurgaon, Haryana , INDIA Phone: ACCOMMODATION: The Leela Kempinski Gurgaon: Contact: Mr. Amitesh Dayal mice.gurgaon@theleela.com Phone: INQUIRY CONTACT: Mr. Md Muneeb Ahsan Phone: Mr. Santhosh Joseph Phone: HRPP2013@medanta.org REGISTRATION FEES: Affiliation Till 28 th June th June 2013 Hospital / Ethics Committee / Academia Rs. 2500/- Rs. 3500/- Pharmaceutical / Biotech / Medical Device / CRO Rs. 4000/- Rs. 5000/- PAYMENT OPTIONS: Cheque / Demand Draft: Payable to Medanta Duke Research Institute Pvt. Ltd., New Delhi Note: Net Banking: A/c No IFSC Code: YESB Bank Name: Yes Bank ltd. 1. In case of payment by Cheque / Demand Draft: Mail back the completed registration form along with the payment to Muneeb Ahsan / Santhosh Joseph at Medanta Duke Research Institute10 th Floor, A-Wing, Medanta-The Medicity Sector-38, Gurgaon In case of payment by Net Banking: Complete the registration form and the scanned copy to HRPP2013@medanta.org

9 REGISTRATIONS FORM Dear Conference Organizer, I would like to register for the HRPP 2013 Conference at THE LEELA KEMPINSKI, Gurgaon on 29 th 30 th June, Following is the completed Registration Form and Payment details: Title: Name: Education: Name of the Institution / Organization: Designation: Phone Number: Correspondence Address: Payment Details: Cheque / Demand Draft Online Bank Transfer (Net Banking) 1. Cheque / Demand Draft: No. dated drawn on bank for Rs,. 2. Net Banking: Transaction id: dated for Rs,. Signature with date: Scientific Content and Organizers: Supported by an Educational Grant from