regulatory Affairs

You are asked to apply your learnings throughout the course to develop a comprehensive
regulatory plan for a drug you make-up. I will be
looking to ensure you apply critical thinking as
you describe the development stages, regulatory
processes, regulations,
procedures, applicable
guidance documents, necessary m
eetings and relevant challenge
s your product will face. You
should begin at the pre-clinical phase; discuss
the steps and activities through to the submission
of the New Drug Application and plans for beyond.
With regard to the drug you invent, please provide
the therapeutic area as well as the indication
you are developing the product for. It is not requi
red to come up with a chemical formulation for
your product, but you are welcome to if you would like.
I recommend that once you review the details fo
r this assignment you begin developing your
regulatory plan by adding to it and revising it week
by week. A table of contents slide should be
included and is also a good way for you to organi
ze your presentation. The last slide of your
presentation should include all your references; yo
u do not need to include references on each of
your slides.
Please do not wait until the last week to work on this. I recommend building it over time. If you
have any questions please do not hesitate to post
your question in the ‘Ask the Instructor’ forum
or email me directly.

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