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Assignment 4 Week 12 Completion requirements Opened: Wednesday, 27 November 2024, 12:00 AM Due: Wednesday, 18 December 2024, 11:59 PM As head of the Regulatory Affairs team in a large Finished Pharmaceutical manufacturing company you have been tasked with laying out a plan for dealing with a new drug application. This drug has just passed development stage and clinical trials and is ready for implementation at the planned site of manufacture, in Dublin. Prior to this you will need to review the work completed in the clinical trials, discuss what you would expect to see upon your review and what you will need for the submission. The drug itself is new with no competing drug on the market and is of great interest to the European market. Assess what route you would take for submission outlining the process and the choice of route. The company itself is a leading manufacturing of similar drugs. Please provide detail on what you would include in this plan under the headings listed below. Title: Provide a suitable and specific title to represent the content of the report. Introduction: Short Introduction with references. Aims: Specify the aims that you will be aiming to achieve. Discussion: Main Content (this section can have headings and sub-headings as well). Sub-headings: Based on the different stages of the key areas impacted in your Pharma company. Flow diagram (if any): Neatly presented (self-made and labelled). Tables (If any): (self-made linked with the flow diagram and labelled). Explanations: For each stage in detail. Conclusion and recommendation: Report. References: Include any References (Harvard Style) Submission Details: Submit project in one MS Word document in Moodle with a word count as below by Weds 18th Dec. Total: 3500 words Max Marks 40% The reason what you will find that the staff is too long is because some basic information touched must be included things like : maintaining … (E.C., EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 2: Personnel, 2013). Production Production operations are required to comply with Good Manufacturing Practices (GMP) to guarantee the quality of products that fulfill necessary manufacturing and marketing authorizations. These procedures must be executed under the supervision of qualified personnel …. Guidelines and regulations cited as per topics Generalised solution for this assignment is not permitted as he wants things I gave examples about, please help me to shorten it as I am ‘dying’ of exhaustion and I am very very too late (1 day if possible) and happy christmas
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