Conferences

 

Learning Objectives

• Understand what is the GCP application guidelines on ‘non-pharma’ trials
• Evaluate the Investigator Responsibilities in Relation to regulations and ethics
• Learn what is the minimum GCP Compliance needed for small companies
• Understand the potential impact of lapses in data privacy
• Master effective clinical research documentation, from protocol development to final reporting and publication of results
• Gain insights into a day in the Life of an activist Institutional Review Board
• Discuss the scope and definition of Misconduct and Fraud
• Learn why Good Laboratories Practice would make a good requisite to GCP
• Address the roles and responsibilities of inspectors, sponsors and auditors and how they affect your SOP
• Discover quality assurance strategies for clinical operation excellence
• Meet, Share, Connect and make new contacts with other professionals in the Pharmaceutical industry around the region

 

Conference Agenda

DAY ONE

8:30 Registration

9:00 Opening remarks from the Chair

9:05 Regulatory Updates: An Overview of the Singapore’s Integrated Research Network
• What is the prevailing clinical trials trend?
• The role of the regulator as an enabler of biomedical sciences initiatives
• Proposed changes to Clinical Trials Regulations
• GCP inspection updates


Dr Foo Yang Tong
Head, Clinical Trials, Product Evaluation and Registration Division
Health Products Regulation Group
Health Science Authority


9:55 A Day in the Life of An Activist Institutional Review Board (Research Ethics Committee)
• The Purpose and Functions of the IRB
• What kinds of Research Review can be performed under IRB Oversight?
• What does a large research site’s IRB look like?
• What happens at a Typical Board meeting?


Dr Steve Stoller
Director of Online Studies
Laureate/University of Liverpool


10:40 Morning Tea

11:00 Good Clinical Practices in Human Subjects Research: Striking a Balance in non-pharma trials
• What defines a “non-pharma” trial?
• Where is the ‘balance”?
• What is at stake?
• The decision making process: extent of monitoring, cost, human research protection, data protection, IRB and regulatory review etc


Emily Tan
Director, Clinical Research Asia
Pharmanet


11:45 Evaluating the Investigator Responsibilities In Relation to Regulations and Ethics
• Updates on FDA, DHHS, GCP and ICH Regulations and Guidelines
• Institutional Human Subject Review
• Informed Consent Process/Development


Dr Ross Horsburgh
Vice President, Asia Pacific
Kendle


12:30 Luncheon

1:30 Clinical Data Management in GCP audits
• Ensuring the validity of data source
• Developing and maintaining an environment that respects the privacy of research subjects
• Understand the potential impact of lapses in data privacy
• Making compliance with data privacy regulations a central focus of GCP audits


David Grennan
Senior Consultant
SeerPharma Singapore Pte Ltd

 
2:15 Quality Systems: The Roadmap to GCP Implementation
•    The Role of the Quality Assurance Auditor
•    Requirements of a good quality management system
•    Quality improvement assurance; quality improvement


Patrecia Flynn Valone
Director, Head Clinical Operations Quality Management Asia Pacific
Quintiles East Asia Pte Ltd


3:00 Afternoon Tea

3:20 Best Practices in Clinical Research: A Sponsor’s Perspective
• Making the right choice in study allocation and feasibility assessments
• Preparing for study initiation
• Study conduct: How to keep skeletons out of the closet
• Study closure and tying up loose ends


Sheila Rankin
Associate Clinical Research Manager
Pfizer Pte Ltd


4:05 GCP implementation and Inspection
• Determine how to best ensure the quality and integrity of human clinical research    
• Getting your site ready for regulatory inspection


Pranab Pillai
Project Manager
Covance (Asia) Pte Ltd


4:45 Closing remarks from the Chair

5:00 Close of Day One


 
DAY TWO

9:00 Opening remarks from the Chair

9:05 What is the Minimum GCP Compliance Needed – Guidance for Small Companies
• The minimal GCP compliance standard
• Challenges faced by small companies in executing GCP-compliant trials
• Guidelines on adaptation


Dr Lay-Beng Goh
Chief Executive Officer
Ben Apex Pte Ltd


9:55 Risk Management and Impact Analysis: Strategies on minimizing exposure for the Sponsor and Clinical Investigator
• Configuring the right risk/benefit ratio
• How do you develop a proactive, comprehensive safety model and risk management strategy
• Selling “GCP excellence culture” as part of the research and development process


Dr Walter Gunzburg
Chairman
Austrianova Singapore Pte Ltd


10:40 Morning Tea

11:00 Clinical Research Documentation – From Protocol Development to Final Reporting and Publication of Results
• The essential clinical study documents
• Regulatory reports and manuscripts for peer-reviewed publication
• Purpose, general structure and important constituents of documents
• Standards, guidelines, ethics and compliance
• Strategic planning, document development process, practical issues and best practices


Dr. Jennie Wong
Senior Manager (Research), University Medicine Cluster
National University Health System


11:45 Good Laboratories Practice: Why GLP would make a good requisite to good GCP
• How sample analysis and its practical in laboratories can be further enhanced by GLP
• Ensuring accurate reconstruction of experiments
• Troubleshooting and Optimization Steps
• Application of GLP Standards to new and existing laboratories practices


Dr S Dhamodaran
Senior Research Scientist, Clinical Laboratories
Clinical Trials and Research Unit
Changi General Hospital


12:30 Luncheon

1:30 Panel Discussion: Facilitated Discussion on Good Clinical Practice

    
Dr S Dhamodaran, Senior Research Scientist, Clinical Laboratories, Clinical Trials and Research Unit, Changi General Hospital
    
Dr Ross Horsburgh, Vice President, Asia Pacific, Kendle
    
Associate Professor Shabbir M Moochhala, Programme Director, Combat Casualty Care Programme, Head Population Genetic Lab, Defence Medical & Environmental Research Institute, DSO National Laboratories


2:15 Conduct Unbecoming in Clinical Research
• Scope and Definition of Misconduct and Fraud
• History and Prevalence of Misconduct
• Government and Industry Experiences
• The Shared Responsibility


Associate Professor Shabbir M Moochhala
Programme Director, Combat Casualty Care Programme
Head Population Genetic Lab, Defence Medical & Environmental Research Institute
DSO National Laboratories


3:00 Afternoon Tea

3:20 Training of Clinical Staff: Why a crucial understanding of GCP is key to effective research
• Going beyond the ‘how to’ aspect of GCP implementation
• How to empower staffs to make informed decision regarding protocols
• Understanding how motivated clinical staffs can lead to higher subject recruitment and retention


Dr Faith Fung
Head of Clinical Operations, Asia Pacific
Sanofi-Aventis


4:05 Knowledge Sharing and Technology Transfer – Creating a symbiotic relationship between educational institutions and research institutes
• Be a conduit from the transparent exchange and understanding of information especially in GCP implementations
• How research institutes can help university create the workforce needed for research organization
• Developing clinical research infrastructure for Singapore’s Life Sciences Initiative
    

Professor David Hogan
Dean, Education Research
National Institute of Education


4:45 Concluding remarks from the Chair

5:00 Close of Conference

 

Workshop Agenda

Workshop Title: Compliance to ICH GCP Guidelines – a Practical Approach

Learning Objectives:

Upon completion of this workshop the attendee should be able to:

1. Understand the Importance of compliance to GCP
2. Discuss the Mechanisms to implement and assure quality through interactive sharing
3. Compare and contrast Auditing versus Monitoring
4. Gain insights to the purpose and requirements of Clinical Quality Assurance (CQA)
5. CQA activities before, during and after a Clinical Site Audit
6. Learn how to handle FDA Inspections:
   • What to expect
   • How to prepare and manage an inspection
   • How to respond to deficiencies
   • Common audit findings