ich and ectd study

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In completing Writing Assignment #1 students will have the opportunity to:

• Demonstrate understanding of the history and impacts of the ICH’s development of eCTD

• Describe the founding regions of the ICH as well as the makeup of the ICH membership with respect to agencies and observers

• Demonstrate knowledge of the basic structure of the eCTD

• Demonstrate an understanding of the basic aspects of the role of regulatory affairs in the eCTD submission process

For this assignment, you are a Sr Manager of Regulatory Affairs at a small, emerging biotechnology company called Silencia Therapeutics. The year is 2018 and you and your colleagues at Silencia Therapeutics are planning to submit your company’s first Investigational New Drug (IND) application to the FDA in order to enable the start of your first in human phase 1 clinical trial. Silencia is a small company of only 15 employees and you are the only regulatory affairs professional in its employ. Additionally, your IND submission is targeted for August 2018, just 4 months after the FDA’s mandatory cutoff for all IND applications to be made electronically in the CTD format. As Silencia is a small company, most of its employees are new to the clinical phases of drug development and have never submitted an IND to FDA and are completely unaware of what the CTD is or how electronic CTD submissions are made. As the Sr Manager of Regulatory Affairs, it is your task to develop an Executive Brief that you will deliver to your peers and also the Chief officers (including CEO!) of the company.

Your executive brief needs to be 5 – 7 pages 12- or 11-point font, double spaced and needs to include, at a minimum, a review of the following information:

• An introduction to ICH, its history, and its current membership. What countries formed the ICH? Are regulators and industry professionals able to join?

• An overview of the rationale for the ICH’s development of the electronic CTD. What is the eCTD and why has ICH developed this document?

• An in-depth review of the benefits of eCTD. How does eCTD help to improve the drug development process?

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