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Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
SEE
ACT
This November
Let’s Come Together to
SEE
THINK
ACT Practical Solutions to Challenges in Research Ethics
- A focus on Human Research Protection Program
3rd & 4th November,
Hotel Matthan, Bangalore
Not just a Conference - A Movement
THINK
Organized by
Supported By an Educational Grant from
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Patrons: Dr. Ramdas Pai - Chairman, MEMG Dr. Ranjan Pai - MD & CEO, MEMG Co Patrons: Mr. Rajen Padukone - CEO & MD MHE Mr. Rakesh Singh – COO – MHE Dr. H. Sudarshan Ballal - Medical Director & Chairman Medical Advisory Board – MHE Dr. Nagendra Swamy S.C. - President - MHE & Chairman- Quality Council, MHE Mr. C.G. Muthana - Vice President – Operations - MHB Conference Email id: [email protected] Manipal Hospitals: Dr. K L Bairy [KMC, Manipal]: 91- 9449208478 Dr. Pratibha Pereira [MHB]: 91-9448282506 Mr. Manjunath M V [MHB]: 91-9902755225 Mr. Benny [MHB]: 91-9986332067 AAHRPP: Dr. Marjorie A. Speers: [email protected] Ms. Sarah Kiskaddon: [email protected] Telephone: +1 2027831112
SEE *
THINK *
ACT
The objective of the conference is to bring together experts and all stakeholders to discuss the current ethical challenges in research, share best practices being followed by organizations and propose solutions. The Program will be conducted in Three Chapters – SEE, THINK and ACT
Chapter I: SEE - The session will use videos, visual displays and poster presentations to set the stage for the conference theme – Practical Solutions to Challenges in Research Ethics. Participating hospitals and organizations are invited to display posters and materials on the following themes:
- Human Protection Measures in your Organization - Practical Solutions to Challenges in Research Ethics
Chapter II: THINK – Thought provoking sessions, panel discussions and expert interviews aimed at engaging audience and stimulating ideas. There will be three main sessions focused on role of (i) Organization, (ii) Ethics Committees & Regulators and (iii) Researchers.
Chapter III: ACT -The culmination of the discussions into the “Action Planning”. The discussion, outcome and solutions proposed during this conference will be published as a paper by AAHRPP [Association for the Accreditation of Human Research Protection Programs] and Manipal Hospitals.
Join the movement if you:
Support ethical research Want to learn how other
organizations are working to protect human research participants
Share best practices and ideas of your organizations [e.g., hospitals, ethics committees, sponsors ]
Understand the global and local perspective of research ethics
Openly discuss challenges with all research stakeholders – See, Think, Act together
Your Forum. Your Voice Join the Movement
Be part of the Solution
Got Ethics?
Join the Movement
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Program Outline
Date: 03-Nov-2012
08:00 – 09:00: Registration 09:00 – 09:30: Inauguration and Welcome: Dr. Nagendra Swamy S.C [President – MHE and
Chairman - Quality Council, MHE]
09:30 – 10:00: Introducing the concept of a Human Research Protection Program Speaker: Dr. Marjorie A. Speers [President and CEO of AAHRPP - Association for the Accreditation of Human Research Protection Programs Inc.]
10:00 – 10:30: Past & Present - Clinical Research Trends, Challenges and Importance Speaker: Dr. Johan Karlberg [Managing Director of Clinical Trial Magnifier Limited]
10:30 – 11:00: Tea/Coffee Break. Poster Display by participating Organizations
Session I: Role of the Organization
11:00 – 12:00: Human Research Protection Program : Building a New Paradigm for Research Panel Discussion – Testimonials and sharing of best practices by organizations Speakers and Panel Discussion Moderator: Dr Bairy Laxminarayana K [Director, Manipal Centre for Clinical Research, Manipal University] Panelists: Dr. Marjorie A. Speers [AAHRPP], Dr. Pratibha Pereira [HOD of Clinical Research Department and Quality Implementation Department, Manipal Hospital Bangalore], Ms. Neelambari [Head Quality Assurance, Jehangir Clinical Development Centre Pvt. Ltd.], Dr. Denis Xavier [Professor and Head, Dept. of Pharmacology, St. John's Medical College; Principal Investigator - NIH Center of Excellence; Coordinator, Division of Clinical Trials, St. John's Research Institute]
12:00 - 13:00: The Legal perspective of Clinical Trials - Informed consent, Compensation, Contracts and Conflict of Interest. Speakers: Samir Kazi [Director Legal, Pfizer], Dr. Milind Antani [Head, Pharma, Life Science and Healthcare Practice at Nishith Desai Associates], Mr. Vasantha Krishna K [Legal consultant for Manipal Education and Medical Group] Q&A Session Moderator: Justice Bannurmath
13:00 – 14:00: Lunch
Welcome & Introduction
CHAPTER II: THINK
CHAPTER I: SEE
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
14:00 – 15:00: Quality Improvement Activities to Improve the Protection of Research Subjects
Panel Discussion - Quality improvement, Indicators and measures by organizations Speaker and Panel Discussion Moderator: Dr. Johan Karlberg [Managing Director of Clinical Trial Magnifier Limited] Panelists: Ms. Sarah Kiskaddon [Director of Business Development, Communications and Public Relations for AAHRPP], Mr. Manjunath V [Quality Implementation - MHE], Mr. Rajesh Saxena [Head Clinical Research, Max Healthcare], Dr. Savita Dhillon [Medical Director, Medanta Duke Research Institute (MDRI)]
Session II: Role of Ethics Committee and Regulators
15:00 – 16:00: Ethics Committees: Protecting Human Subjects – Challenges Panel discussion – Ethics Committees: What More Can Be Done?
Speaker: Dr. Nandini K Kumar [Former Deputy Director General, Senior Grade (ICMR)] Moderator: Dr. Urmila Thatte [Professor and Head at the Department of Clinical Pharmacology, Seth GS Medical College & KEM Hospital, Mumbai] Panelists: Dr. Nandini K Kumar, Dr. (Prof.) P.P. Bapsy Sr. Consultant, Medical Oncologist [Apollo Hospitals, Bangalore], Dr. R. B. Ghooi [Professor of Drug Discovery and Clinical Research at Symbiosis International University, Pune], Dr. Joseph Thomas [Professor of Urology, Kasturba Medical College]
16:00 – 16:30: Tea/Coffee Break. Poster Display by participating Organizations 16:30 – 17:00: Indian Regulations - Protecting Human Participants
Speaker: Prof. Arunabha Ray [Head, Dept. of Pharmacology at Vallabhbhai Patel Chest Institute, Faculty of Medicine, University of Delhi]
Date: 04-Nov-2012
Session II: Role of Ethics Committee and Regulators continued… 09:00 –09:30: US FDA Expectations from Clinical Trials to Protect Human Participants -
Warning Letter and Inspection Trends, Observations and Implications for Sponsors, Organizations, Researchers and Ethics Committees Speaker: Shehnaz Vakharia [Founder and Principal Consultant Theraverity]
09:30 – 10:30: Systematic Assessment of Research Risk - Protocol Evaluation and Assessing Risks and Potential Benefit Speaker: Dr. J. Andrew Bertolatus [Associate Professor, University of Iowa; Co-chair of the University of Iowa Biomedical Institutional Review Board (IRB). Member of the Council for AAHRPP]
CHAPTER II: THINK
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Session III: Role of Researchers 10:30 – 11:00: Compliance and Data Integrity in Clinical Research - Avoiding Protocol,
Deviations, Reducing Bias, Accurate Recording and Interpretation of Data, Preventing Research Misconduct. Speaker: Dr. Arun Bhatt [President, Clininvent Research Pvt Ltd.]
11:00 – 11:30: Tea /Coffee & Networking 11:30 – 12:30: Protecting Human Subjects in a Clinical Trial: Investigator’s Role
Panel Discussion - Role and need for research coordinators - Effective models using research coordinators and Investigators Speaker: Dr. Dinesh C Doval [Director, Medical Oncology and Research, Rajiv Gandhi Cancer Institute] Moderator: Dr. Poonam Patil [Consultant Medical Oncologist, Manipal Hospital Bangalore] Panelists: Dr. Arun Bhatt [President, Clininvent Research Pvt Ltd.], Lalit Pai [Pharma Research Entrepreneur, Cytespace], Dr. Raju Titus Chacko [Professor of Medicine and Medical Oncology, Head Medical Oncology service at the Christian Medical College, Vellore], Dr. P. Usha Rani [Additional Professor; Dept of Clinical Pharmacology and Therapeutics, Nizam’s Institute of Medical Sciences], Dr. P K L Nandini [SI Team Leader, RMH/ H.O.D CR BGS Global Hospital]
12:30 – 13:30: Lunch
13:30 – 14:15: Applying Failure Mode and Effect Analysis [FMEA] Methodology to Continuous
Improvement at Investigator Sites: Challenges in Clinical Research, Public Perception, Root Cause Analysis. Speaker: Dr. Mohanish Anand [Senior Director, Investigator Site Strategy, Pfizer US]
14:15 -15:00: Building a Robust Human Research Protection Program. Speaker: Sarah H. Kiskaddon [Director of Business Development, Communications and Public Relations for Association for the Accreditation of Human Research Protection Programs [AAHRPP]
15:00 – 15:30: Tea /Coffee & Networking 15:30 – 16:00: Role of Training and Education on Clinical Research Practices in Improving
Research. Speaker: Dr. Kamala Rai [Medical Director, Novartis]
16:00 – 17:00: Practical Solutions to Challenges in Research Ethics Panel Discussion - Future: What needs to be done to ensure credibility of India? Speaker: Dr. Pratibha Pereira [HOD of Clinical Research Department and Quality Implementation Department, MHB], Suchela Srivatsa [Head – Integrated Site Services, India, Quintiles] Moderator: Dr. Chandrashekhar Potkar [Director, Medical and Regulatory Affairs, Pfizer India] Panelists: Dr. K Bopanna [President & Executive Director, Semler Research Centre], Dr. Nagendra Swamy S.C [President - MHE & Chairman- Quality Council, MHE], Hemant Rehani [Quintiles VP & Head Clinical Development Services India], Prof. A Ray [Professor& Head, Pharmacology, VPCI], Dr Siddharth Lascar [ Radiation Oncologist, Member Secretary and IRB II, Tata Memorial Hospital], Dr. Amar Jesani [Founder of the Forum for Medical Ethics Society, Founder and Editor of IJME (Indian Journal of Medical Ethics)]
CHAPTER III: ACT
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Marjorie A. Speers President and CEO of the Association for
the Accreditation of Human Research Protection Programs, Inc., (AAHRPP)
Sarah H. Kiskaddon Director of Business Development,
Communications and Public Relations for Association for the Accreditation of Human Research Protection Programs
Inc., (AAHRPP}
Dr. Karlberg Managing Director of Clinical Trial
Magnifier Limited
Dr. J. Andrew Bertolatus Associate Professor, University of Iowa;
Co-chair of the University of Iowa Biomedical Institutional Review Board.
Member of the Council for AAHRPP]
Dr Arun D Bhatt President, Clininvent Research Pvt Ltd.
Dr. Nandini K. Kumar Former Deputy Director General Sr.
Grade(ICMR)
Dr. Urmila Thatte Professor and Head at the Department
of Clinical Pharmacology, Seth GS Medical College & KEM Hospital,
Mumbai
Chandrashekhar Potkar Director, Medical and Regulatory Affairs
Pfizer Limited – India
Dr. Amar Jesani Founder of the Forum for Medical Ethics
Society, Founder and Editor of IJME (Indian Journal of Medical Ethics)
Speaker & Panelists
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Dr. Mohanish Anand Senior Director, Global Investigator Site
Strategy, Pfizer US
Dr Bairy Laxminarayana K Director, Manipal Centre for Clinical
Research, Manipal University
Prof. P.P. Bapsy
Sr. Consultant – Medical Oncologist, Apollo Hospitals, Bangalore. Former
Prof. & Head – Medical Oncology
Prof. Arunabha Ray
Head, Dept. of Pharmacology at Vallabhbhai Patel Chest Institute,
Faculty of Medicine, University of Delhi.
Dr. Milind Antani Head, Pharma, Life Science and
Healthcare Practice at Nishith Desai Associates
Dr. R. B. Ghooi Professor of Drug Discovery and Clinical
Research at Symbiosis International University, Pune
Dr. P.Usha Rani Additional Professor; Dept of Clinical
Pharmacology and Therapeutics; Nizam’s Institute of Medical Sciences
Dr. Kamala Rai Medical Director, Novartis
Dr. Joseph Thomas Professor of Urology ,
Kasturba Medical College
Speaker & Panelists
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Dr. Krathish Bopanna President & Chief Executive Officer,
Semler Research Centre, Bangalore
Dr Raju Titus Chacko Professor of Medicine and Medical Oncology, Head Medical Oncology
service at the Christian Medical College, Vellore, Tamil Nadu, India.
Dr. Pratibha Pereira
HOD of Clinical Research Department and Quality Implementation
Department, Manipal Hospital Bangalore
Mrs. Neelambari Bhosale Head Quality Assurance,
Jehangir Clinical Development Centre Pvt. Ltd.
Savita Dhillon Medical Director, Medanta Duke
Research Institute (MDRI)
Mr. Vasantha Krishna K Legal consultant for Manipal Education
and Medical Group.
Rajesh Saxena
Head Clinical Research, Max Healthcare
Dr.P.K.L.Nandini SI Team Leader [RMH]/ H.O.D Clinical Research [BGS Global
Hospital]
Mr. Manjunath V Quality Implementation - MHE
Speaker & Panelists
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Hemant Rehani Quintiles VP & Head Clinical Development Services India
Dr. Denis Xavier Professor and Head, Dept. of
Pharmacology, St. John's Medical College; Principal Investigator - NIH Center of Excellence; Coordinator, Division of Clinical Trials, St. John's
Research Institute.
Dr. Poonam Patil Consultant Medical Oncologist, Manipal
Hospital Bangalore
Dr. Dinesh C Doval Director, Medical Oncology & Research,
Rajiv Gandhi Cancer Institute
Mr. Samir Kazi Director, Legal, Pfizer
Justice Bannurmath Ethics Committee Manipal Hospital
Bangalore
Suchela Srivatsa Head – Integrated Site Services,
Quintiles
Lalit Pai Pharma Research Entrepreneur,
Cytespace,
Shehnaz Vakharia Founder and Principal Consultant
Theraverity
Speaker & Panelists
Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program
Bangalore: 3rd – 4th November 2012
Scientific Content and Conference Organizers: Supported By an Educational Grant from
Dr. Nagendra Swamy S.C President - MHE & Chairman- Quality Council, MHE
[Manipal Health Enterprises]
Dr Siddharth Laskar
Radiation Oncologist, Member Secretary, IRB II, Tata Memorial Hospital
Registration Registration Fee [Includes tea and Lunch on both days] Industry Academia
Rs. 3000 Rs. 1000
*Additional Rs. 500 for spot registration Please send in the completed Registration form to the following address: PSCRE Conference, C/0 Srivarshini. A.K, Manipal Hospital, Clinical Research Center, 7th Floor, 98, HAL Airport Road, Bangalore -560017, Mobile: +91 - 9986697282, Office. +91- 80-25024631
Venue: Hotel Matthan, #134, HAL Airport Road, Kodihalli, Bangalore-17. Ph No.: 080 42494949, Fax : 080 42494948 www.matthan.in Hotel & Logistics Queries: Ramya K , Cell : + 91- 7795809001, Off. +91-80-25024631, Poster: Dimensions of the poster display can be up to 4 feet high and 3 feet wide. Last date for submitting posters – 10th October 2012 For any queries contact: [email protected]
Speaker & Panelists
Registration
Got Ethics? - Join the Movement