BUSINESS TOOLS FOR PHARMACEUTICAL SCIENTISTS

PHMSCI 751

Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse pharmaceutical industry. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.

PHMSCI 680

Learn about essential components of drug development and cutting-edge research in drug discovery, drug action, and drug delivery. Focus on useful and practical information and essential underpinnings in chemistry, biology, physical chemistry, and engineering.

PHMSCI 759

Provides the experience and skill to find, read and critically analyze scientific and regulatory literature in the field of drug discovery and development.

PHMSCI 757

Scientific process of drug development from discovery through clinical trials. Brief history of drug development, along with an overview of drug discovery, preclinical, and clinical activities that take place during development. Application to real-world drug development scenarios and challenges, especially as they apply to development of drugs to treat neurological diseases.

PHMSCI 753

Key concepts and body of knowledge of Project Management (PM) applied to the specifics of the drug development process. PM theory and language. The life cycle of a project: Initiating, Planning, Executing, Monitoring and Control, and Closing. Predictive, adaptive and hybrid PM frameworks and tools. Project Charter, statement-of-work, scope of work, work-breakdown structure, project network and timelines. Critical path method and earned value analysis to adjust schedules, allocate resources, and implement corrective actions. Risk management in pharmaceutical projects. An overview of documents management and decision-making strategies.