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: pscre_conference2012@yahoo.in 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: mspeers@aahrpp.org Ms. Sarah Kiskaddon: skiskaddon@aahrpp.org 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: pscre_conference2012@yahoo.in

Speaker & Panelists

Registration

Got Ethics? - Join the Movement