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November 2017

eCTD Submissions of IND/NDA to the US FDA, EU and Canada

November 15 @ 10:00 am - 11:30 am
Live Webinar

Live Webinar Date: Wednesday November 15, 2017 Time: 10:00 AM ET | 7:00 AM PT Duration: 90mins with Q&A This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs…

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Packaging & Labeling

November 28 @ 10:00 am - 11:30 am
Live Webinar

Live Webinar Date: Tuesday November 28, 2017 Time: 10:00 AM ET | 7:00 AM PT Duration: 90mins with Q&A   Program will discuss practical development of packaging design and optimizing the design to fit the intended purpose. You will learn to translate a protocol into optimal package design.  A review of the compliance requirements between commercial and clinical packaging and labeling will be completed.  Review a case study of changing commercial packaging for optimization. The program will review how to establish…

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