This hy-flex course addresses important issues related to quality and regulatory science of pharmaceuticals and the course provides important information on strategies for these areas.  The course at an intermediate level and is intended to address many basic aspects of the topic areas.  Regulatory submissions and quality concepts will be addressed.  The course includes online sessions, synchronous sessions, and/or case studies.

Modern pharmaceutical companies must conduct drug discovery, development, manufacturing, and marketing in a highly regulated environment with increasing competition and pricing pressures.  Systems for quality manufacturing, quality by design of manufacturing processes, and regulatory excellence are critical elements for success in this complex and evolving environment.  Every effort must be made to ensure drugs are safe and effective for the intended indication.  The cost of poor quality and the penalties for non-compliance are unacceptable in today’s drug development business.  Knowledge of effective quality principles and practices is critical to getting things right the first time. This course will provide information on best-in-class methods for quality systems and regulatory science. 

The rationale of the course is based on the concept that high quality and appropriate compliance (QA/QC) are essential for the viability of industry, and academia as well.  Almost daily, examples come to light showing the downside of poor quality or compliance:  operations or organization closed, fines levied, careers affected, public images besmirched, and credibility lost.  Furthermore, there is concern and evidence that for TB drugs, lack of efficacy, or diminished efficacy, due to poor quality, leads to the development of resistant bacteria.