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
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