REG 510 – Introduction to Clinical & Translational Research
Instructor: Emma Meagher, MD
Time: MW, 8:30 – 10 am
Modality: Online
Open to nondegree: Yes
This introductory course lays the foundation for understanding practical aspects of designing and conducting clinical research in an academic environment. The course is divided into two modules: Module 1: Trial Design and Execution and Module 2: Regulatory Environment for clinical research inclusive of clinical trials. The first module introduces clinical research, clinical protocols, study design and execution and the drug development process. The second module covers ethical considerations in clinical research, study oversight, and the regulatory environment for clinical trials . Upon completion, students should have a strong foundation in the fundamentals of clinical research.
Contact: Bethany Sanghani (bgermany@upenn.edu) with questions
Complete the course request form if you are interested in registering for the course
REG 616 Quality Assurance
Instructor: Dawn Lundin
Time: Tuesdays, 4 – 7 pm
Modality: Online
Open to nondegree: Yes
Quality assurance (QA) plays a critical role in the reliability and reproducibility of product development and, manufacturing. As a component of the Quality Management System, quality assurance includes all activities performed by an organization for the prevention of errors and defects. This course intends to focus on QA principles, standards and requirements, with regard to the FDA-regulated product development lifecycle. Further, the course aims to offer examples of QA and quality control measures through auditing monitoring and risk management. Application of quality assurance and the interfaces between GLP, GTP,GMP-and Pharmacovigilance regulatory regulated activities during product development and manufacturing will also be addressed.
Contact: Bethany Sanghani (bgermany@upenn.edu) with questions
Complete the course request form if you are interested in registering for the course