●  The Data Monitoring Committee: A Collective or a Collection?

●  Evolution of Phase II Oncology Trial Design: from Single Arm to Master Protocol

●  Quality Tolerance Limits’ Place in the Quality Management System and Link to the Statistical Trial Design: Case Studies and Recommendations from Early Adopters

●  A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry

●  Important Considerations for Signal Detection and Evaluation

●  Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis Partners

●  Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

●  Statistical Considerations on the Use of RWD/RWE for Oncology Drug Approvals: Overview and Lessons Learned

●  A Comparison of Instructions for Use Documents and Manufacturer Produced Administration Videos for Biological Products

●  Validation of Artificial Intelligence Containing Products Across the Regulated Healthcare Industries

●  Horizon Scanning in Tissue Engineering Using Citation Network Analysis

●  EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age

●  An Extended Framework of Multiple Testing in Group Sequential Design

●  Exploratory Analysis of Drug Lag in New Oncology Drugs Between Japan and the US

●  Results and Feasibility of the Virtual Inspection of Clinical Trials During Pandemic of COVID-19 in Peru

●  Review of the Food and Drug Administration’s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle Communications

●  Adaptation of the WOMAC for Use in a Patient Preference Study

●  Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers

●  Efficient Risk Mitigation Planning for a Clinical Trial

●  Comparison Between Simultaneous and Sequential Utilization of Safety and Efficacy for Optimal Dose Determination in Bayesian Model-Assisted Designs

●  Factors Affecting Success of New Drug Clinical Trials

●  Linguistic Analysis of Generic-Generic Drug Name Pairs Prone to Wrong-Drug Errors for which Tall-Man Lettering is Recommended

●  An Industry Survey on Unmet Needs in South Korea’s New Drug Listing System

●  Digital Tools—Regulatory Considerations for Application in Clinical Trials

●  The Challenges for Manufacturers of the Increased Clinical Evaluation in the European Medical Device Regulations: A Quantitative Study