Research Presentations (session 1 of 5) - Aikawa, Sakamaki and Shivani

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Philippines Conference Room
Encina Hall, Third Floor, Central, C330
616 Jane Stanford Way, Stanford, CA 94305

In this session of the Corporate Affiliates Research Presentations, the following will be presented:

Yuta Aikawa, Ministry of Economy, Trade & Industry, Japan, "A Study About a Government Policy to Develop Defense Industry"

In April 2014, under consideration of the recent situation of international cooperation and developing defense equipment in the world, the government of Japan decided on the “Three Principles on Transfer of Defense Equipment and Technology”.  Additionally, the Acquisition, Technology and Logistics Agency was newly established in the Ministry of Defense (MOD) in October 2015, consolidating and reorganizing acquisition-related organization in the MOD to address the new age and duties.  These recent changes could have a big impact on the defense industry in Japan.  In his research, Aikawa tries to figure out how to develop the defense industry by looking at the situation in South Korea, whose government recently developed to export defense equipment to other countries.  Aikawa uses this example to illustrate implications for the government of Japan on the future of the defense industry.

 

Tsuzuri Sakamaki, MInistry of Finance, Japan, "What Impact Would the Ongoing Basel III Implementation Procedure Have on Banks' Value Creation and Risk Management?"

Basel III has been developed in response to the financial crisis that started in 2007 and reached one of its many peaks with the Lehman Brothers bankruptcy in September 2008.  The aim of the Basel Committee on Banking Supervision (BCBS) implementing Basel III is to make the banking system more resilient to market stress, but this new regulation inevitably limits the ability of banks to take deposits and lend money to the real economy.  Banks are also under constant pressure from their own shareholders who are providing them with equity capital to maximize the usage of the capital in order to achieve high returns for them.  With all these regulatory policy intensions and market economic constraints taken into account, Sakamaki has researched into whether the Basel III would indeed lead to increased stability of the banking system, or what possibly unintended negative consequences could develop in its implementation process.

 

Ravishankar Shivani, Reliance Life Sciences, "Pharmaceutical Process Validation — A Science and Risk-Based Approach to Evaluate Impact of Changes on Regulatory Filings"

Regional differences in regulatory oversight of post-approval changes exists in the ICH regions and there is an urgent need for clarification of current expectations and how best to optimize the use of relevant regulatory tools in place in the different regions.  The key aspects considered are 1) inclusion of risk-based regulatory commitment approach to enable post-approval changes and continual improvement,  2) establishing criteria for an harmonized risk-based change management system, and 3) introducing the concept of post-approval change management plan for regulatory overview. 

Shivani has researched the possibilities of changes to the attributes of a product over the life cycle that are necessary to maintain product quality and efficacy.  His research identifies the methodology for inclusion of the proposed changes during the development phase as commitments in dossiers to facilitate regulatory assessment. 

 


 

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