regulatory Affairs

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 ‘Ask the Instructor’ forum or email me directly.