The Regulatory Science Community represents a diverse community of scientists from biopharmaceutical industry, government, and academia who are interested in the science of clinical pharmacology and translational medicine and the application to the drug development process, with an ultimate aim to enhance patient care.
The goal of the Regulatory Science Community is to promote interaction between drug development scientists, clinicians, and regulators to facilitate integration of a broad expanse of skill sets required to develop a molecule into a clinically useful therapeutic entity. This is accomplished through the following:
Education and Communication:
Education on hot topics in regulatory sciences, both in clinical pharmacology and drug development. This includes discussion of influence and impact of clinical pharmacology, translational medicine, and regulatory science:
- Present examples of clinical pharmacology that made a difference in drug development and usage.
- High impact examples of modeling and simulation and impact on regulatory approvals and drug development decision making.
- High impact examples of where systems pharmacology made a difference to the label.
- How to translate information into a label (labeling associate director).
- Outreach to global regulatory agencies to discuss key hot topic issues.
Advance the scientific expertise in regulatory science by promoting collaboration between academic, industrial, and regulatory scientists including:
- Key external groups
- Key ASCPT groups