Presentations

A Practical Overview of Clinical Development for Biosimilars (294.63 KB)
Adaptive Clinical Services: A CRO's Perspective (1.85 MB)
Biosimilars in the US: Some Analytical, Non-clinical and Clinical Considerations (218.81 KB)
Clinical Development Partnership with Biotechnology Companies in Asia Pacific (482.8 KB)
Clinical Trial Materials Supply Chain (499.47 KB)
Clinical Trials in Asia Pacific (798.63 KB)
Continuous Metrics Interchange (5.46 MB)
CTA's Outside the US - How Do Clinical Trial Agreements and Processes Look Outside of the US? (229.74 KB)
Designing Sae and Effecient Phase Studies to Expedite Clinical Development (312.07 KB)
Development and Commercialisation Framework for Biosimilars_Creating a Clinical Strategy (795.31 KB)
Does Global Challenge the Synergy of CDM (2.88 MB)
Early Clinical PK_PD Development Phase for Biosimilars (1.61 MB)
English on the Go (1.68 MB)
FDA Approaches to Combination Therapies (97.42 KB)
FDA Cell Selection Point of Care Guidance (182.13 KB)
FDAs Critical Path Initiative and Drug Development (304.8 KB)
Human Vaccines and TSE Agents: A Case Study in Risk Evaluation and Risk Management (164.21 KB)
Impact of Global Regulatory Guidelines_Updates on Clinical Trials for Biosimilars (596.68 KB)
Issues in Observational Research Survey Findings (990.59 KB)
Jurisdictional Issues Assoc with HCT/Ps (857.88 KB)
Measures of Potency (262.76 KB)
Meeting Global Regulatory Requirements in Early Phase Studies (763.34 KB)
Novel Vaccine Manufacturing Platforms; Novel Concerns (290.57 KB)
Novel Vaccine Technologies/Cell Substrates (539.06 KB)
Nuances of Resource Planning and Utilization (116.7 KB)
Observational Research: A Critical Element for Post-Approval Success (364.6 KB)
Observational Studies and Patient Registeries (1.46 MB)
Overview of Follow on Biologics in Asia Pacific Region (5.13 MB)
Patient Registry Case Study (653.77 KB)
Regulatory and Scientific Considerations on Development of the Biosimilars in the Asia Region (469.21 KB)
Regulatory Environment for Clinical Studies in Asia Pacific (313.41 KB)
Regulatory Perspective/Active Immunotherapeutics (127.68 KB)
Stability Studies for Cell Therapies (324.49 KB)
The Impact of Technology on Observational Research (904.64 KB)
US Regulatory Perspective on Stability Testing (95.33 KB)
Vaccine Adjuvants Regulatory Considerations (145.44 KB)