News and Insights

Strategic Approaches to Regulatory and Compliance

Germany Post AMNOG: Insights for BioPharma

BioPharm International

Manufacturers exploring opportunities in global markets face dynamic demographic and disease trends, changing market demands, and evolving regulatory requirements—all of which differ from one country to another. While emerging markets continue to represent a new channel of demand for pharmaceutical products, manufacturers have quickly realized that significant attention must still…

Integrating RWE into Investigator Initiated Trials

Pharmaceutical Compliance Monitor

Expanding government and payer requirements for additional data on products, whether for safety monitoring, efficacy confirmation or economic and clinical value evaluation, underscore the importance of an integrated strategy for investigator initiated trials (IIT) and real world evidence (RWE) research. In developing an IIT/RWE strategy, companies need to be clear…