A. Chamblee, Esq., RAC, F*RAPS

Johns Hopkins Course Information

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Advanced Academic Programs Biotechnology Overview

Regulatory Processes for Domestic and Global Biotech Products
Regulatory affairs (RA) comprises the rules and regulations governing product development and post-approval marketing. In the U.S., the FDA establishes and oversees the applicable regulations. Biotechnology products may be classified as drugs, biologics, or medical devices. Each type is regulated by a different center within the FDA. This course provides an overview of RA and its impact on product development. Topics include: RA history, regulatory agencies, how to access regulatory information, drug submissions, biologics submissions, medical device submissions, GLP, GCP, GMP, and FDA inspections.

I have been teaching this class on line for the past few years, and I like the interaction.  On-line, a student doesn't just listen to a lecture, but must provide information, questions, and opinions and share stories from their work.  My on-line students have said they learn a lot from this, although it requires more thought, preparation - and therefore time - before each class.  Because the interaction works well, traditional classes that I teach will not be a lecture class.  The assignments will be to review the slides before class and be prepared to ask a question or discuss an issue.  Each week, one or two students will sign up for a topic that interests them and they will lead the discussion.  I will work with those students one or two weeks in advance and help them get ready.  I will pass out the list of topics to all the students at the same time, so they have an equal chance to choose.

 

Because each week is so important, and requires extra preparation, and because students will get feedback and information each week, I have no prepared exams.  The grade will be based on participation each week, the topic that the student leads, and a final group project where students prepare for an FDA meeting.  Students who need to skip more than one class, or who want extra credit, can attend one of the many free local meetings with FDA or trade association and tell the class about it.

 

Before the class, there is a lot of great information on the FDA website, www.fda.gov

 

Try especially here: http://www.eduneering.com/fda/courses/fdatour/welcome.html

and here http://www.fda.gov/oc/history/default.htm

and here for drug information:  http://www.fda.gov/cder/index.html

and here for device information:   http://www.fda.gov/cdrh/devadvice/

 

I love to keep my class improving all the time, so if you have any suggestions or any concerns, please let me know.

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