Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program : 3rd – 4th November 2012 This November

Let’s Come Together to SEE SEE

THINK

ACT

Practical Solutions to Challenges in Research Ethics - A focus on Human Research

Protection Program THINK

3rd & 4th November, Hotel Matthan, Bangalore

Not just a Conference - A Movement

Organized by

ACT

Scientific Content and Conference Organizers: Supported By an Educational Grant from 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

Patrons: Dr. - Chairman, MEMG Join the movement if you: Dr. Ranjan Pai - MD & CEO, MEMG Co Patrons:  Mr. Rajen Padukone - CEO & MD MHE Support ethical research Mr. Rakesh Singh – COO – MHE Got Ethics?  Want to learn how other Dr. H. Sudarshan Ballal - Medical organizations are working to protect Director & Chairman Medical Advisory Board – MHE human research participants Join the  Dr. Nagendra Swamy S.C. - President - Share best practices and ideas of MHE & Chairman- Quality Council, MHE your organizations [e.g., hospitals, Mr. C.G. Muthana - Vice President – Movement ethics committees, sponsors ] Operations - MHB  Understand the global and local

Conference Email id: perspective of research ethics [email protected]  Openly discuss challenges with all Your Forum. Your Voice research stakeholders – See, Think, Manipal Hospitals: Join the Movement Dr. K L Bairy [KMC, Manipal]: Act together 91- 9449208478 Be part of the Solution Dr. Pratibha Pereira [MHB]:

91-9448282506 Mr. Manjunath M V [MHB]: The objective of the conference is to bring together experts and all stakeholders 91-9902755225 to discuss the current ethical challenges in research, share best practices being Mr. Benny [MHB]: 91-9986332067 followed by organizations and propose solutions.

AAHRPP: Dr. Marjorie A. Speers: The Program will be conducted in Three Chapters – SEE, THINK and ACT [email protected] Ms. Sarah Kiskaddon: Chapter I: SEE - The session will use videos, visual displays and poster [email protected] presentations to set the stage for the conference theme – Practical Solutions to Telephone: +1 2027831112 Challenges in Research Ethics.

SEE 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 THINK 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. ACT

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.

Scientific Content and Conference Organizers: Supported By an Educational Grant from

Practical Solutions to Challenges in Research Ethics A focus on Human Research Protection Program rd th Bangalore: 3 – 4 November 2012

Program Outline

Date: 03-Nov-2012

Welcome & Introduction

08:00 – 09:00: Registration 09:00 – 09:30: Inauguration and Welcome: Dr. Nagendra Swamy S.C [President – MHE and Chairman - Quality Council, MHE]

CHAPTER I: SEE

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

CHAPTER II: THINK 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

Scientific Content and Conference Organizers: 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

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, ] 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, ] 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 ]

Date: 04-Nov-2012

CHAPTER II: THINK 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]

Scientific Content and Conference Organizers: 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

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

CHAPTER III: ACT 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 ? 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)]

Scientific Content and Conference Organizers: 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

Speaker & Panelists

Marjorie A. Speers Sarah H. Kiskaddon Dr. Karlberg President and CEO of the Association for Director of Business Development, Managing Director of Clinical Trial the Accreditation of Human Research Communications and Public Relations Magnifier Limited Protection Programs, Inc., (AAHRPP) for Association for the Accreditation of Human Research Protection Programs Inc., (AAHRPP}

Dr. J. Andrew Bertolatus

Associate Professor, University of Iowa; Dr Arun D Bhatt Co-chair of the University of Iowa Dr. Nandini K. Kumar President, Clininvent Research Pvt Ltd. Biomedical Institutional Review Board. Former Deputy Director General Sr. Member of the Council for AAHRPP] Grade(ICMR)

Dr. Urmila Thatte Chandrashekhar Potkar Dr. Amar Jesani Professor and Head at the Department Director, Medical and Regulatory Affairs Founder of the Forum for Medical Ethics of Clinical Pharmacology, Seth GS Pfizer Limited – India Society, Founder and Editor of IJME Medical College & KEM Hospital, (Indian Journal of Medical Ethics) Mumbai

Scientific Content and Conference Organizers: 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

Speaker & Panelists

Prof. P.P. Bapsy Dr. Mohanish Anand Dr Bairy Laxminarayana K Sr. Consultant – Medical Oncologist, Senior Director, Global Investigator Site Director, Manipal Centre for Clinical Apollo Hospitals, Bangalore. Former Strategy, Pfizer US Research, Manipal University Prof. & Head – Medical Oncology

Dr. R. B. Ghooi Dr. Milind Antani Prof. Arunabha Ray Professor of Drug Discovery and Clinical Head, Pharma, Life Science and Head, Dept. of Pharmacology at Research at Symbiosis International Healthcare Practice at Nishith Desai Vallabhbhai Patel Chest Institute, University, Pune Associates Faculty of Medicine, University of Delhi.

Dr. Joseph Thomas Dr. P.Usha Rani Professor of Urology , Additional Professor; Dept of Clinical Dr. Kamala Rai Kasturba Medical College Pharmacology and Therapeutics; Medical Director, Novartis Nizam’s Institute of Medical Sciences

Scientific Content and Conference Organizers: 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

Speaker & Panelists

Dr. Pratibha Pereira Dr. Krathish Bopanna Dr Raju Titus Chacko HOD of Clinical Research Department President & Chief Executive Officer, Professor of Medicine and Medical and Quality Implementation Semler Research Centre, Bangalore Oncology, Head Medical Oncology Department, Manipal Hospital service at the Christian Medical Bangalore College, Vellore, Tamil Nadu, India.

Mrs. Neelambari Bhosale Savita Dhillon Mr. Vasantha Krishna K Head Quality Assurance, Medical Director, Medanta Duke Legal consultant for Manipal Education Jehangir Clinical Development Centre Research Institute (MDRI) and Medical Group. Pvt. Ltd.

Rajesh Saxena Dr.P.K.L.Nandini Mr. Manjunath V Head Clinical Research, SI Team Leader [RMH]/ H.O.D Quality Implementation - MHE Max Healthcare Clinical Research [BGS Global Hospital]

Scientific Content and Conference Organizers: 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

Speaker & Panelists

Dr. Denis Xavier Hemant Rehani Professor and Head, Dept. of Dr. Poonam Patil Quintiles VP & Head Clinical Pharmacology, St. John's Medical Consultant Medical Oncologist, Manipal Development Services India College; Principal Investigator - NIH Hospital Bangalore Center of Excellence; Coordinator, Division of Clinical Trials, St. John's Research Institute.

Justice Bannurmath Mr. Samir Kazi Ethics Committee Manipal Hospital Dr. Dinesh C Doval Director, Legal, Pfizer Bangalore Director, Medical Oncology & Research,

Rajiv Gandhi Cancer Institute

Suchela Srivatsa Lalit Pai Shehnaz Vakharia Head – Integrated Site Services, Pharma Research Entrepreneur, Founder and Principal Consultant Quintiles Cytespace, Theraverity

Scientific Content and Conference Organizers: 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

Speaker & Panelists

Dr. Nagendra Swamy S.C Dr Siddharth Laskar President - MHE & Chairman- Quality Council, MHE Radiation Oncologist, Member Secretary, [Manipal Health Enterprises] IRB II, Tata Memorial Hospital

Got Ethics? - Join the Movement

Registration

Registration Venue: Registration Fee [Includes tea and Lunch on both days] Hotel Matthan, #134, HAL Airport Road, Industry Academia Kodihalli, Bangalore-17. Ph No.: 080 42494949, Fax : 080 42494948 www.matthan.in Rs. 3000 Rs. 1000 Hotel & Logistics Queries: Ramya K , Cell : + 91- 7795809001, Off. +91-80-25024631, *Additional Rs. 500 for spot registration Poster: Dimensions of the poster display can be up to Please send in the completed Registration form to the 4 feet high and 3 feet wide. th following address: PSCRE Conference, C/0 Srivarshini. A.K, Last date for submitting posters – 10 October 2012 Manipal Hospital, Clinical Research Center, 7th Floor, 98, HAL Airport Road, Bangalore -560017, For any queries contact: Mobile: +91 - 9986697282, Office. +91- 80-25024631 [email protected]

Scientific Content and Conference Organizers: Supported By an Educational Grant from