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Page 1: 3rd Asia Pacific Research Ethics Conference Conference ... · 3rd Asia Pacific Research Ethics Conference Conference Programme ... Dr Teoh Yee Leong ... National University of Singapore

Correct as of 21 Jan 2014 Page 1 of 11

3rd Asia Pacific Research Ethics Conference

Conference Programme Time/Venue Day 1 – 27 March 2014

0730 – 0900 Registration and Collection of Conference Badge

0900 - 1000

Opening Ceremony

Welcome Address: A/Prof Chin Jing Jih

Chairman, Organising Committee, APREC 2014

Divisional Chairman, Integrative & Community Care,

Tan Tock Seng Hospital, Singapore

Opening Address: Prof Chee Yam Cheng

Group Chief Executive Officer, National Healthcare Group

Keynote Speaker: Prof Nancy Kass

Phoebe R. Berman Professor of Bioethics and Public Health,

Berman Institute of Bioethics and Johns Hopkins,

Bloomberg School of Public Health

United States

Keynote Title: International Research Ethics: Rules, Guidelines, and Experiences from the

Field

1000 – 1030

Tea break

1030 - 1200 Concurrent Sessions

Session A1: Ethical Challenges in Population Health Research - Part 1

Chairperson:

Speakers Designation & Institution Topic

Prof Michael Tai

(Taiwan)

Professor,

Chungshan Medical University,

MOH Bureau of Health Promotion,

International Society for Clinical

Bioethics

Deception and Informed Consent in

Social, Behavioral and Educational

Research

Prof Lee Wing

On

(Singapore)

Dean,

Office of Education Research,

National Institute of Education

(NIE)

Research on Population Health in

Singapore: The Development of the

Research Ethics Board on Community

Heath (Domain Specific Review Board),

2012-2013

Session A2: Hot Topics on Quality of Clinical Research

Chairperson:

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Speakers Designation & Institution Topic

Ms Marisa

Petersen

(Australia)

General Manager

George Clinical Pty Ltd

TBC

Dr Marjorie A.

Speers

(USA)

Consultant,

Association for the Accreditation of

Human Research Protection

Programs (AAHRPP)

TBC

Session A3: Current Trends and Best Practices in Managing the Challenges in Clinical Trials and

Drugs or Device Development

Chairperson:

Speakers Designation & Institution Topic

Dr Victoria

Elegant

(China)

Vice President,

Medical Regulatory and Clinical

Affairs, APAC

Baxter Healthcare

Current Challenges in Managing Clinical

Trials in Asia Pacific

Ms Catherine

Lee

(Taiwan)

Area Head,

Clinical Trial Support and

Compliance Asia

Pfizer Inc

Current Trends/Best Practices in

Managing the Challenges in Clinical

Trials Conduct in Asia under Strategic

Partnership Model with CRO-from

Sponsor Perspective

Ms Emily Tan

(Singapore)

Vice President,

Clinical Operations, Asia Pacific,

<InVentiv Health Clinical

Current Trends/ Best Practices in

Managing the Challenges in Clinical

Trials and Drugs/ Device Development

Session A4: Hot Topics in Research

Chairperson:

Speakers Designation & Institution Topic

Prof Michael

Selgelid

(Australia)

Director,

Centre for Human Bioethics

Monash University

Research Ethics in Controlled Infection

Studies

Dr Susan Fish

(USA)

Professor of Biostatistics and

Epidemiology,

Boston University School of

Medicine

Alternative Consent

Ms Elizabeth

Bankert

(USA)

Assistant Provost,

Dartmouth College

Parkhurst Hall, Hanover

1200 – 1330

Networking Lunch

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1330 – 1500 Concurrent Sessions

Session B1: IRB Training Requirement of a Principal Investigator (PI): The Essential

Components of an Educational Program for Pis and Research Staff

Chairperson:

Speakers Designation & Institution Topic Ms Marisa

Petersen

(Australia)

General Manager,

George Clinical Pty Ltd

Training for Investigative Sites – Beyond

GCP

Dr Elyse

Summers

(USA)

President and CEO,

The Association for the

Accreditation of Human Research

Protection Programs (AAHRPP)

IRB Education

Prof Masayuki

Yoshida

(Japan)

Director,

Life Science and Bioethics Research

Center

Research Ethics Education for IRB

Members and Researchers: Current

Status in Japan

Session B2: Quality Risk Management in Industry-sponsored Clinical Trials

Chairperson:

Speakers Designation & Institution Topic

Ms Monica Lau

(Singapore)

Principal Advisor,

Quality Capability Development

and Clinical Quality Assurance,

GlaxoSmithKline (GSK) Pte Ltd

Sharing Audit and Inspection Findings

with Investigator Sites

Ms Sangeetha

P. Myles

(India)

Investigator Site Development

Lead,

Clinical Trial Support & Compliance

Pfizer Limited,

Pfizer Centre

Failure Mode and Effects Analysis

(FMEA)

Session B3: Project Management and Monitoring in Contract Research Organizations or

Pharmaceutical Companies

Chairperson:

Speakers Designation & Institution Topic

Dr Yeo Jing Ping

(Singapore)

Senior Portfolio Director of Project

Management,

Paraxel International

The Art of Project Management – How?

Mr Bhausaheb

Patil

(Singapore)

Senior Director and Head Clinical

Site monitoring Quality

Management (CSMQM) Asia,

Quintiles East Asia Pte Ltd

Risked Based Monitoring: Using Novel

Technologies for Effective Study

Oversight

Mr Leong Regional Manager, Risk-Based Monitoring in Clinical Trials

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Cheong Guan

(Singapore)

Clinical Development of Quality

Assurance,

GlaxsoSmithKline Pte Ltd

Session B4: Bio-similars: Patent Drugs vs their Generic counterparts

Vaccine Clinical Trials: The Ethics Behind it

Chairperson:

Speakers Designation & Institution Topic

Dr Teoh Yee

Leong

(Singapore)

Chief Executive Officer,

Singapore Clinical Research

Institute

Ethical Challenges in Vaccine Clinical

Trials

Dr Jeremy

Sugarman

(USA)

Deputy Director for Medicine,

John Hopkins Berman Institute of

Bioethics

Ethical Issues in the Clinical Translation

of Stem Cell Research

Dr Amar

Kureishi

(Singapore)

Chief Medical Officer and Head of

Drug Development Asia,

Quintiles

Biosimilars and the Ethics of Innovative

Medicines

1500-1600 Concurrent Sessions

Session C1: Policies and Procedures to Conduct Clinical Research in Vulnerable Population

Chairperson:

Speakers Designation & Institution Topic

Dr Elsie Lynn B.

Locson

(Philippines)

Pediatrician,

Department of Pediatrics,

Dr. Fe del Mundo Medical Center

Vulnerability of Children, A Must To

Remember

Dr Bruce

Gordon

(USA)

Executive Chairman, Institutional

Review Boards

Chairman, Joint Pediatric IRB

Professor and Division Chief

Pediatric Hematology/Oncology &

Stem Cell Transplantation

University of Nebraska Medical

Center

TBC

Session C2: How to Ace your Audit and Health Authority Inspections

Chairperson:

Speakers Designation & Institution Topic

Ms Valerie Tan

(Singapore)

Senior CRA Group Manager,

Novartis (Singapore) Pte Ltd

Top 10 Tips to Help You Ace Your Next

Audit and Inspection

Ms Monelle Quality Assurance Director, TBC

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Payet

(Singapore)

Pharmaceutical Product

Development (PPD)

Session C3: Understanding Proportionality

Chairperson:

Speakers Designation & Institution Topic

A/Prof Calvin

Ho

(Singapore)

Mr. Chan Tuck

Wai

(Singapore)

Assistant Professor,

Centre for Biomedical Ethics,

Yong Loo Lin School of Medicine,

National University of Singapore

Senior Associate Director and

Secretariat of the NUS Institutional

Review Board (NUS-IRB),

Human Protections Administrator

of the National University of

Singapore (NUS)

Proportionality in Informed Consent: A

Balancing Act?

Dr Xie Huiting

(Singapore)

Senior Staff Nurse,

Nursing Training,

Institute of Mental Health

Clinical Vs Researcher: Is There a

Conflict between the Ethical

Considerations in Research and Nature

of Being a Clinician?

Session C4: The Ethics of Openness: How Informed is Informed Consent?

Chairperson:

Speakers Designation & Institution Topic

Dr Emily Shen

(Australia)

Visiting Medical Officer,

Department of Medicine,

Maroondah Hospital

Department of Gastroenterology,

Eastern Health

How Informed is Informed Consent?

Dr Karabee

Mukherjee

(India)

Manager and Clinical Trainer,

Clinical Trials and Research

Department Apollo Gleneagles

Hospital

Make that Consent Informed

1600-1630

Tea Break

1630 - 1730 Keynote 1

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Chairperson:

Keynote Speaker: Prof Bernard Lo

President, The Greenwall Foundation

Professor of Medicine Emeritus,

Director Emeritus, Program in Medical Ethics,

University of California San Francisco United States

Keynote Title: Global Principles and Asian Cultural Traditions: Finding Common Ground

1730-1800

Poster Presentation / Free Viewing

Time/Venue Day 2 – 28 March 2014

0800 - 0900 Registration

0900 - 1000 Keynote 2

Chairperson:

Keynote Speaker: Prof Michael Selgelid

Director, Centre for Human Bioethics

Monash University

Australia

Keynote Title: Relationships between Public Health Surveillance Ethics and Human Subjects

Research Ethics

1000 – 1030

Tea Break

1030 - 1200 Concurrent Sessions

Session D1: Ethical Challenges in Population Health Research - Part 2

Chairperson:

Speakers Designation & Institution Topic

Prof Shang-Yung

Yen

(Taiwan)

Professor,

Graduate Institute of Management

of Technology

Feng Chia University

TBC

Prof Vajira

Dissanayake

(Sri Lanka)

Professor, Faculty of Medicine,

University of Colombo

Critical Perspectives on Collaboration,

Governance and Competition in Health

Research - Findings of the Biomedical

and Health Experimentation in South

Asia Study Group

Prof Susan Fish Professor of Biostatistics and TBC

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(USA)

Epidemiology,

Boston University School of

Medicine

Session D2: Quality Risk Management in Investigator-initiated Clinical Trials

Chairperson:

Speakers Designation & Institution Topic

Ms Angie Sim

(Singapore)

Regional Quality and Compliance

Director (AP),

Global Clinical Operations,

Johnson and Johnson PRD

Quality Risk Management from Sponsor

Perspective

Ms Emily Tan

(Singapore)

Vice President,

Clinical Operations, Asia Pacific,

inVentiv Health Clinical

TBC

Session D3: Responsible Conduct of Research – Whose Responsibility Is It?

Chairperson:

Speakers Designation & Institution Topic

A/Prof Calvin Ho

(Singapore)

Assistant Professor ,

Centre for Biomedical Ethics,

Yong Loo Lin School of Medicine,

National University of Singapore

Ethical Responsibility to Consider

Accessibility of Medicines in Research

Prof Byung-In

Choe

(Korea)

Professor,

Nicholas Cardinal Cheong

Graduate School for Life,

The Catholic University of Korea

Improving National Quality Assessment

and Accreditation System of an IRB in

Korea: The Challenges and Opportunities

Mr Tony Mayer

(Singapore)

Research Integrity Officer,

Nanyang Technological University

Embedding Research Integrity in a Fast-

Rising and Research-Intensive Asian

University

Session D4: Payment to Research Subjects: Avoiding Coercion, Undue Influence, and

Exploitation

Chairperson:

Speakers Designation & Institution Topic

Dr Emily Shen

(Australia)

Visiting Medical Officer,

Department of Medicine,

Maroondah Hospital

Department of Gastroenterology,

Eastern Health

Payment to Research Subjects: Avoiding

Undue Influence

A/Prof Daniel

Fung

(Singapore)

Chairman Medical Board,

Institute of Mental Health

Reimbursement, Reward or Bribery? A

Singaporean Experience for Child and

Adolescent Research

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Dr Danny Soon

(Singapore)

Managing Director,

Lilly-NUS Centre for Clinical

Pharmacology

Can We Justify Paying Volunteers for

Research Participation

1200 – 1300

Lunch

1300 - 1400

Concurrent Sessions

Session E1: Management of Conflict of Interest by IRB

Chairperson:

Speakers Designation & Institution Topic

Dr Marjorie A.

Speers

(USA)

Consultant,

Association for the Accreditation

of Human Research Protection

Programs (AAHRPP)

TBC

Ms Elizabeth

Bankert

(USA)

Assistant Provost,

Dartmouth College

Parkhurst Hall, Hanover

TBC

Session E2: Quality Indicators as a Quantitative Way of Tracking Quality. Benchmark and Sharing

Amongst Countries as to How Others Track Their Quality Management Processes

Chairperson:

Speakers Designation & Institution Topic

Dr Elyse I.

Summers

(USA)

President and CEO,

Association for the Accreditation

of Human Research Protection

Programs (AAHRPP)

Use of Quality Indicators to Track Quality

in Academic Institution

Dr Manju Rani

(Philippines)

Senior Technical Officer (Health

Research),

Western Pacific Regional Office

World Health Organization

Improving Transparency and

Harmonization of Procedures for

Research Ethics Oversight: Development

and Use of Online IT Solutions

Session E3: Best Practices for Effective Site Selection and Recruitment

Chairperson:

Speakers Designation & Institution Topic

Ms Joanne Chio

(Singapore)

Head Clinical Trials,

Haematology-Oncology Research

Group, National Cancer Institute,

National University Health System

Recruiting Humans Subjects: Current

Challenges and Strategies to Overcome it

– A Site Perspective

Ms Jill Wong

(Singapore)

Clinical Study Manager

Danone Nutricia Research

Should Social Media (Facebook, LinkedIn

etc) be Used in Clinical Research? – The

Pros and Cons of Using Social Media

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Session E4: Recent Developments in Medical Device Regulation and Enforcement, South East

Asia and beyond

Chairperson:

Speakers Designation & Institution Topic

A/Prof Tan Sze

Wee

(Singapore)

Deputy Executive Director,

Agency for Science, Technology

and Research, Biomedical

Research Council

Research Ethics in Biomedical and

Medical Device Research

1400 - 1530 Concurrent Sessions

Session F1-1: Ethical and Legal Considerations in Human Subjects Research

Chairperson:

Speakers Designation & Institution Topic

A/Prof Terry

Kaan

(Singapore)

Associate Professor,

National University of Singapore

TBC

Prof Elizabeth

Pangalangan

(Philippines)

Professor of Law,

University of the Philippines

TBC

Dr Roli Mathur

(India)

Scientist,

Indian Council for Medical

Research,

Ansari Nagar, New Delhi

TBC

Session F1-2: Administrative Screening Processes for the IRB (IRB Framework and Operations) or

Best Practices and Other Strategies for Managing IRBs

Chairperson:

Speakers Designation & Institution Topic

Dr Wang Meixia

(China)

Director,

Beijing You’an Hospital,

Capital Medical University

Non-Compliance and Protocol Deviation

Report

Dr Sriwimon

Manochiopinig

(Thailand)

Assistant Professor,

Siriraj Institutional Review Board

Faculty of Medicine,

Siriraj Hospital Mahidol University

Siriraj IRB’s Continuous Quality

Improvement (CQI) Program

Dr Felix Gyi

(USA)

Founder & CEO

Chesapeake IRB

Practical and Robust Evaluation Program

of EC/IRB Members

Session F2: Quality Improvement - Ethical and Regulatory Issues

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Chairperson:

Speakers Designation & Institution Topic

Dr Benjamin Kou

(Taiwan)

Chairman,

Human Subject Protection,

Association in Taiwan (HuSPAT)

TBC

Ms Sumitra

Sachidanandan

(Singapore)

GCP Inspection Consultant,

Clinical Trials Branch,

Health Sciences Authority

Better Prepare than Repair - Quality

Improvement Initiatives by the Health

Sciences Authority

Session F4: The Social and Ethical Issues of Tissue Banking for Research

Chairperson:

Speakers Designation & Institution Topic

Ms Helena Ellis

(USA)

Director,

Duke Biobank

Consideration and Protection of

Research patients in the Consent Process

and Participation in Duke's Tissue

Banking Protocol

Prof Alastair

Campbell

(Singapore)

Chen Su Lan Centennial Chair in

Medical Ethics,

Director, Centre for Biomedical

Ethics,

Yong Loo Lin School of Medicine

National University of Singapore

Tissue Banking for Research : Ethical and

Regulatory Challenges

Mr Chan Tuck

Wai

(Singapore)

Senior Associate Director and

Secretariat of the NUS Institutional

Review Board (NUS-IRB),

Human Protections Administrator

of the National University of

Singapore (NUS)

Human Biological Materials:

Abandonment, Donation or Research

Participation

1530 - 1600

Tea break

1600 - 1700 Keynote 3

Chairperson:

Keynote Speaker: Prof Kon Oi Lian

Division Head (Medical Sciences)

National Cancer Centre

Chair, NCCS Research Committee

Singapore

Keynote Title: The Naked Genome

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NOTE

• Scientific programme is accurate at the time of update. Details are subject to changes.

• For the latest Conference program, please check our website at www.aprec-nhg.com.sg