Day 1 – Saturday, 29 June 2013

ROYAL ROOM

08:00 – 09:00: Registration

09:00 – 10:00: Welcome & Inauguration

Speakers:

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

Speakers:

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

Panelist:

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

Speakers:

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

Session Theme: Impact & Implementation of New Regulations

Welcome & Introduction

Mr. Solomon Yimam, Assistant Country Director (Clinical Research) U.S. FDA India Office, India

Panelist:

Dr. Robert Califf, Vice Chancellor Director, Duke Translational Medicine Institute, USA

TBD, Biopharma Industry Professional

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

Speakers:

Dr. Marjorie A. Speers, President and CEO of AAHRPP,USA

Dr. Mohanish Anand, Senior Director, Global Investigator Site Strategy, Pfizer Inc., USA

TBD, Academia

Panelist:

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

Speakers:

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

Panelist:

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

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

Speakers:

Dr. Bairy Laxminarayana K, Director, Manipal Centre for Clinical Research, Manipal, India

Mr. Pathik Divate, CEO, Jehangir Clinical Development Center (JCDC), India

Session Theme: Patients First – Focus of Human Research Protection Program

Session Theme: Quality, Compliance & Public Perception

Dr. Chandrika Arora, Former Senior Director & Head Clinical Operations - Quintiles (India)

Panelist:

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

Panelist:

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.

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

Session Theme: Seeking AAHRPP Accreditation

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

Speakers:

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

Panelist:

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

Day 2 – Sunday, 30 June 2013

BOARD ROOM LOUNGE

Conducted By: Indian Society for Clinical Research

9:30 – 10:30: Expanding EC roles: Are we biting more than we can chew? - Debate

Speakers:

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

Speakers:

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

Speakers:

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

Session Theme: Ethics in India: Expanding Horizons

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-122 002, INDIA

Phone: +91 124 477 1234

ACCOMMODATION:

The Leela Kempinski Gurgaon:

Contact: Mr. Amitesh Dayal

Email: mice.gurgaon@theleela.com

Phone: +91 124 477 1136

INQUIRY CONTACT:

Mr. Md Muneeb Ahsan Phone: +91 98181 52572

Mr. Santhosh Joseph Phone: +91 8527 374455

Email: HRPP2013@medanta.org

REGISTRATION FEES:

Affiliation Till 28th

June 2013 29th

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

Net Banking:

A/c No. 000383900000226

IFSC Code: YESB0000003

Bank Name: Yes Bank ltd.

Note:

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 Institute10th Floor, A-Wing,

Medanta-The Medicity Sector-38, Gurgaon – 122 001

2. In case of payment by Net Banking: Complete the registration form and email the scanned copy to

HRPP2013@medanta.org

REGISTRATIONS FORM

Dear Conference Organizer,

I would like to register for the HRPP 2013 Conference at THE LEELA KEMPINSKI, Gurgaon on 29th – 30

th

June, 2013. Following is the completed Registration Form and Payment details:

Title:_____________________________________________________________________________________

Name:____________________________________________________________________________________

Education:_________________________________________________________________________________

Name of the Institution / Organization:__________________________________________________________

Designation:_______________________________________________________________________________

Phone Number:__________________________ Email:_____________________________________________

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