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TRANSCRIPT
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:
Correct as of 21 Jan 2014 Page 2 of 11
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
Correct as of 21 Jan 2014 Page 3 of 11
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
Correct as of 21 Jan 2014 Page 4 of 11
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
Correct as of 21 Jan 2014 Page 5 of 11
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
Correct as of 21 Jan 2014 Page 6 of 11
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
Correct as of 21 Jan 2014 Page 7 of 11
(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
Correct as of 21 Jan 2014 Page 8 of 11
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
Correct as of 21 Jan 2014 Page 9 of 11
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
Correct as of 21 Jan 2014 Page 10 of 11
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
Correct as of 21 Jan 2014 Page 11 of 11
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