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Global Change of Regulations for Regulatory Affairs in electronic Submission Management for API, Generic and Originators
時間: 2018年11月30日(五) 11:00-11:30. 南港展覽館404會議室

This presentation will show the Global Regulatory changes which affects the Regulatory Departments in handling Dossier submissions to Global and local Agencies and how to overcome the ongoing regulations and how to provide high quality and adequate Submissions for applications of Drugs, Drug Substances and Medical devices to the Food and Drug Associations around the world like US FDA, Health Canada, MCC South Africa, EMA, EU, Switzerland, Australia (TGA) Thailand, GCC, China and other regions.
More and more countries subscribing the ICH (The International Conference on Harmonisation) and going the next step into global electronic dossier submissions like CTD, NeeS and eCTD, to provide better services to the industry for quicker Application review and approval.
In this presentation the attendees will see and learn about the global Agencies approach from the beginning and it will show an outlook of the future Submissions and regulations around the Globe and how to overcome the constantly changing regulations.

主講: Stefan Horneborg / Senior Business Development Manager APAC & MENA
主辦單位: EXTEDO GmbH (德國)
2018台灣醫療科技展 Roadshow 創新技術發表會 線上報名網頁

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