Category: Regulatory & Safety
Cell and Gene Therapy Lesson 3: A Developing, Growing and Changing Regulatory Landscape
Cell and Gene Therapy Lesson 4: Undefined Methodologies, Unstable Technology and Potential Challenges in the GMP Regulatory Environment
Natural History Studies in Rare Diseases and Genetic Biomarkers
Outsourcing from a Pharmacovigilance Perspective
The Do’s and Don’ts of Randomization in Clinical Trials
Balancing Scientific Value and Identification Risk in Anonymization
Eligibility Criteria in Clinical Trials
The Future of The Local Regulatory Affiliate: Adjusting To Global Strategies, Processes and Expectations
Positive Changes in the Latin American Clinical Trial Regulatory Environment