Harmonization of CDISC standards for Regulatory submissions
Journal Title: IOSR journal of Business and Management - Year 2018, Vol 20, Issue 9
Abstract
Harmonization plays a key role in the modern world due to its impact on resourcing and budgeting. When submitting the dossier to regulatory agencies the requirements differ hence, there should be guidelines for companies to set the differences right. The drug development process submissions should be done in an integrated way to regulatory agencies although there are major differences between them. We should prioritize our requirement for easy implementation and determination. Since it causes double work to be done to regulatory agencies, we need to identify the gap and the requirement of implementation of the model and the need for standardization of regulations globally. Has time finally come to harmonize regulatory agency requirements across the world? if not now, can it be done in due course of time? The major challenges to have this implemented include globalization, approval time shortening, enhancing safety measures and accelerated review process. Until then, the drug development submission process should be done in an integrated way considering the differences. There is a need for inter organisational harmonisation process and companies must reconsider in the study package during the initial trial phase. This paper will outline the requirement of regulatory harmonization across globe and the need for inter-organisational harmonisation model. This helps in providing an overview of implementation of one model of harmonization approach and strategies for effective planning and harmonization of company specific implementation standards.
Authors and Affiliations
Alagupriya Somasundaram, Dr. S. Madhavan
Keywords
Related Articles
- EP ID EP412436
- DOI 10.9790/487X-2009010813.
- Views 71
- Downloads 0
Factors Affecting Post-Initial Public Offer of Listed Companies at the Nairobi Securities Exchange
Initial Public Offerings (IPOs) have recently become popular as way of sourcing for funds by organizations and to the investors by buying shares in those companies. However, IPO can be a risky investment avenue because o...
Organisational Change Management and Employees Productivity in the Nigeria Banking Sector
The essence of this study effort is to investigate what consequence change has on organizations and how best these consequences can be addressed to ensure that employees’ productivity is enhanced. It thus covers major ba...
Attitude of In and Out-Group Employees and Leader Member Exchange
Leader member Exchange (LMX) theory focuses on the quality of Leader-members two-way relationship (dyadic relationships); that is directly related to organizational success. It’s proved that relationship of leader with s...
Indian Entrepreneurial Communities: The People Who Set-up Their Businesses
Entrepreneurship has been considered as a major source of employment generation, economic growth and prosperity of a nation. India is also not an exception for good entrepreneurship. India which was famous for its’ prosp...
The Professionalism on Indonesian Navy Vessel’s officer
The purpose of the research is to establish the Reality Descriptions about the Professionalism on Indonesian navy vessel’s (KRI) officer. The data analysis was revealed through and based on the discovered data about ship...