Course Detail: BIOT107 - DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS

DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS: Students will learn about topics such as Quality by Design, Good Lab Practice, Molecule Design by QbD, Vaccine Potency Testing, Design of Clinical Trials, Vaccine Regulation and Preclinical Studies, cGMP Manufacturing and Compliance, and COVID-19 Disease and Biopharmaceutical Approaches.

Upon completion of this course students will be able to demonstrate: 

  • An in-depth understanding of the history and current organization of the Food and Drug Administration (FDA), the development of the regulatory process, the history of key regulations and how to obtain FDA clearance to initiate clinical trials on new biotechnology products. 
  • An understanding of the process of biotechnology product development, including clinical stages and design of clinical trials and the various regulatory submissions.
  • An understanding of the submission requirements supporting clinical trials. 

Guest speakers include staff from AstraZeneca, FDA, and Glaxo SmithKline.

This course is not limited to UMBC students and is open to the general public.  The course is offered in our Live Online Synchronous format.  All lectures will be recorded to accommodate international students and professionals with challenging schedules. 

 Session Detail: 2218CERBIOT107P101

Schedule: Every week on Wednesday, starting on 09/01/21 and ending on 12/15/21
Times: 06:00pm - 08:45pm
REGULAR PRICE : $1500.00

Facility Detail

Live Online Synchronous
Live Online Synchronous: (LOS)
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Live Online Synchronous: (LOS)