regulatory Affairs

You are asked to apply your learnings thr

oughout 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 ëAsk the Instructorí forum 

or email me directly. 

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