Category: Regulatory & Safety

Cell and Gene Therapy Lesson 1: Acronyms, Buzzwords and Crucial Lingo

Cell and Gene Therapy Lesson 2: Remarkable Therapies Call For Complex Clinical Trials

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