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ITMAT Education Fall 2021 Course Offerings

July 21, 2021 by Rebecca Lopez Leave a Comment

The Master's of Science in Translational Research is pleased to announce  the thesis dissertation defense of

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

Filed Under: Announcements, Courses Tagged With: Career: Research (academic)

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