Regulatory and Manufacturing Practices

Catalog description

This course required by the PhD program will provide to the student the fundamentals behind the regulatory guidelines and regulations related to the quality of a pharmaceutical drug throughout it’s life cycle. Starting from the development of the drug, sub mission and clinical trials, manufacturing process development, commercial manufacture, up to it’s discontinuation. The student will learn through interactive lectures and class discussions the regulations and guidelines developed and/or embraced by the Fo od and Drug Administration, such as Code of Federal regulations (CFRs), FDA Frameworks and Guidelines, and the International Conference on Harmonization (ICH), and the European Medicines Agency (EMA) regulations. PHSC 8600- Principles in Research Design-Two (2) credits. In this course the students will be exposed to the skills necessary for writing a successful research proposal including basic concepts, statement of problem, hypothesis, objectives, design of experiments, experiment planning, analysis of the data and docu mentation of results. At the end of the course the students will be required to submit an original completed research proposal.