solved Demonstrate understanding of the history and impacts of the ICH’s

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. Your company has recently successfully developed a new drug and now, you and your cross-functional colleagues at Silencia Therapeutics are planning to submit your company’s first New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA.
Silencia is a small company of only 15 employees and you are the only regulatory affairs professional in its employ. As Silencia is a small company, most of its employees do not know what ICH or the eCTD are and require some help from their regulatory affairs team members!
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 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 basics of electronic CTD. What is the eCTD and why has ICH developed this dossier format? What are the major differences between eCTD submissions to the FDA vs. EMA?
A review of the benefits of eCTD. How does eCTD help to improve the drug development process?