Global Harmonization – Global Regulatory and Clinical Affairs for Drug Development
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*Mark Bach, Merck 


The goal of industry to support global registration of new drugs and vaccines is challenging because of medical, regulatory and operational issues. Disease prevalence, genetic and environmental factors and concomitant therapy may vary by region. Regulatory issues include study approval timelines ranging from one to eight months, sometimes conflicting requirements for study design, requirements for country-specific sub-analyses, and increasing scrutiny of studies performed in emerging markets. Operational challenges include variable local infrastructure, the need to execute a trial across multiple languages and time zones, and in some cases, lack of well-trained investigators. The presentation will review these issues and potential solutions.