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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: [email protected]
Phone: +91 124 477 1136
INQUIRY CONTACT:
Mr. Md Muneeb Ahsan Phone: +91 98181 52572
Mr. Santhosh Joseph Phone: +91 8527 374455
Email: [email protected]
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
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