Category: Regulatory & Safety

Regulatory Insights: Pandemic Speeds Adoption of Telemedicine in Clinical Trials

Regulatory Insights: COVID-19 and its Impact on the Regulatory Affairs Landscape

Successfully Managing Change in Your Pharmacovigilance System

Successful Partnering in Pharmacovigilance For Clinical Trials

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