E-Presentations

• The Future of Health Care Innovation: Complementary Challenges for the US, Singapore, and the World
• Strategies to Enhance Value to Our Patients in a Singapore Hospital
• Using Health Technology Assessment to Improve Clinical Outcomes and Manage Costs
• Applying Global Innovations in Singapore
• A Journey to Measuring and Delivering Value for Patients in SingHealth
• Using Real-World Evidence – What, Why and How?

• Enabling Innovations through Collaborations in Advancing Healthcare
• Current Priorities for Health and Biomedical Sciences Research in Singapore
• Collaborations in Harnessing Data Analytics for Active Surveillance
• Overview of Regulatory Approaches for Cell, Tissue and Gene Therapy Products
• Regulation of Advanced Therapy Medicinal Products in Europe
• Risk-based Methods For Regulatory Review: Practical Experience and Key Consideration
• HSA's Collaborative Efforts in Enhancing Access to Generic Therapeutic Products
• Continued Efforts Towards Promoting Good Submission Practice
• Application of Good Review Practices in Ensuring Product Safety, Efficacy and Quality
• Good Distribution Practice: Practical Approaches to Improve Compliance

• New Frontiers In International Regulatory Science
• Update on the Asia Training Centre from PMDA’s Roadmap
• Enhancing The Responsiveness of Regulatory Systems to Global Health Needs
• Nurturing the Next Generation Of Regulatory Leaders
• Ensuring Regulatory Impact and Relevance
• Developing A Holistic Curriculum For The Regulatory Professionals
• Maximising Healthcare Impact Through Using Perspectives from Patients
• Approaches To Implementing Good Submission Practices
• Establishing Centres of Excellence – APEC RHSC
• Good Regulatory Practices for Medical Technology
• Opportunities For Knowledge Transfer Among Regulatory Stakeholders
• Sustainable Healthcare – Opportunities for Paradigm Shifts In Health Products
• The PUCRI Approach In Enhancing Regulatory Capability
• Evolving Post-Market Activities For Effective Life Cycle Management
• Mobile Tech for Enhancing Clinical Monitoring
• Precision Medicine Through Pharmacogenomics
• Regulatory Convergence Activities - APEC Harmonisation Centre (AHC)
• Regulatory Systems Strengthening

• Driver of Successful Regulatory Transformation: Experience from the PMDA
• Exploring Opportunities And Challenges Of Regulatory Convergence
• Regulation, Health Technology Assessment, Payers
• Improving Healthcare: Opportunities for Regulatory Innovation
• Stepping into Regulatory Excellence through Convergence
• Is Referencing and Reliance a Feasible Approach for ASEAN?
• CoRE's Initiative to Enhance Regulatory Capabillities in ASEAN
• Mobile Health Apps - Implications on Healthcare and Opportunities for Regulatory Affairs
• Accommodating Trends in Personalised Medicines: Evolving Regulatory Frameworks
• Health Technology Assessment - Impact on Regulations and Healthcare in Singapore
• Emerging Developments in Advanced Therapeutics - Regenerative Medicine:
• Sustainable Development Goals: Facilitating Regulatory Excellence and Timely Access to New and Advanced Therapies
• Emerging Role of Academia in Regulatory Education
• 3D Printing From Development to Market: Overcoming Regulatory Barrier
• Prospects of Partnerships Among ASEAN Regulatory Stakeholders - Industry Perspective
• Regulation of Devices in Asia - Recent Changes and Outlook for the Future

CoRE Scientific Symposium 2017: Impact of Real-World Evidence on regulatory decision-making and systems

• Can Real World Evidence Replace Randomised Controlled Trials
• The Influence of Real World Evidence in Shaping the Regulatory Landscape
• Real World Evidence in Medical Device Regulation

Pharmacovigilance

• Risk Management Strategy: A European Point of View
• A Point on the Methidology for Evaluating the Effectiveness and Burden of the Different Risk Minimisation Methods
• Pharmacovigilance in Singapore
• Industry Experience in Risk Minimization Methods and the Assessment of Their Effectiveness

Precision Medicines and Companion Diagnostics

• Challenges in Bringing Precision Medicines to Patients
• Regulatory Perspective on CDx in Japan
• Precision Medicine and Companion Diagnostics: Regulatory Framework
• Regulation of Precision Medicine and Companion Diagnostics – Singapore’s Perspective
• Companion Diagnostics: Current Frameworks and Processes: US FDA experience

Advanced Therapies (2017)

• Welcome and Introductions for APEC RHSC Centre of Excellence Pilot Workshop on Advanced Therapies
• Introducing APEC RHSC CoE Pilot on Advanced Therapies
• 21st Century Cures Act
• Trials For Advanced Therapies Typical Characteristics Of Trials
• Regulation of Regenerative Medicine in Japan
• Update from Korea MFDS on Understanding The Basis of Framework and Process in Asia For Advanced Therapies
• Updates on Regulatory Framework in Singapore
• Overview of The Development of Advanced Therapies
• USP Standards for Cell- and Tissue-based Therapies
• GMP Requirements - Manufacturer's Perspective
• Ethics of An Unregulated Industry Selling Stem Cell Therapies

Bioequivalence

• Approaches to Assessing Bioequivalence in ASEAN
• Regulatory Strategy For Generic Drugs
• Overview of BE Approaches for Different Dosage Forms
• BE Approaches For Oral Dispersible Tablets
• BE Approaches for Modified Release Oral Solid Dosage Forms
• The US Pharmacopeia Revision Process
• In-Vitro Dissolution Testing
• BCS-based Biowaivers: What and Where?
• Requirements for BCS-based Biowaivers
• Addressing Challenges in Bioequivalence Through Collaboration and Work-sharing