regulatory affairs
Paper details:
These instructions were on the document labeled changes
I have clarified and attached the required documents as the writer did not make the changes and continued to not
make the changes
as itinally stated this is part 2 of the indication module
I need the changes done not like how it was initially which is copy and paste from the sample indication module.
Please confirm that you are working on it as soon as possible.
Please check the file 267012 | Changes.doc .
These changes were not done 4. Using the medical reviews and pivotal trial documents please fill in the
highlighted sections Under section 3.0 Global Regulatory Strategic Considerations and use the attached
documents named : Rytary pivotal trial, Duopa pivotal , Northera pivotal study, Nuplazid pivotal study ,Northera
medical review,Nuplazid Medical Review, Rytary medical review, and duopa medical review.
Client:
1. In the Section 2.2.1 Precedent Pivotal Trial Designs please provide a summary of all the conclusion of the
clinical trial data using the attached documents called Rytary pivotal trial, Duopa pivotal , Northera pivotal study
and Nuplazid pivotal study.
2. In section 2.1.3 Applications referred to advisory committees/scientific advisory groups please add a
summary in Table 2.c of the attached document called advisory committee Northera
3. In section 2.5 Health Authority Guidances and Communications Related to Indication under 2.5.1.1 please
use the information found http://www.aafp.org/afp/2007/0315/p922.html and fill in the table. Also under section
2.5.1.2 Europe use the guidance attached named indication related guidance documents Parkinson and create a
table like the one provided.
4. Using the medical reviews and pivotal trial documents please fill in the highlighted sections Under section 3.0
Global Regulatory Strategic Considerations and use the attached documents named : Rytary pivotal trial, Duopa
pivotal , Northera pivotal study, Nuplazid pivotal study ,Northera medical review,Nuplazid Medical Review, Rytary
medical review, and duopa medical review.
Client:
please make the changes

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.