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Royal Tulip Brasília Alvorada Hotel

2024 年 09 月 25 日 8:00 上午 - 2024 年 09 月 26 日 4:00 下午

Shtn - Trechno 01, Conj 1Bb - Bloco C, 40800-200 Brasília, Brazil

Latin America Annual Meeting

Take advantage of opportunities for networking and knowledge sharing with key stakeholders influencing the advancement and implementation of initiatives in Latin America.

Early Bird Rates Expire

DAYS

HOURS

MINUTES

SECONDS

Session 7, Track A: CTD/eCTD and Cloud-based System Solutions: Future Vision

Session Chair(s)

Flavia  Firmino Ribeiro, PharmD

Flavia Firmino Ribeiro, PharmD

Director Reg Global CMC

Pfizer, Brazil

Representative Invited

Representative Invited

AstraZeneca, United States

Representative Invited

Representative Invited

Merck Serono Limited, United Kingdom

In this session, speakers will discuss the future vision and potential enhancements of CTD and eCTD for regulatory submissions. The session will explore advancements in technology and best practices that can further improve the effectiveness and acceptance of these formats. Participants will also have the opportunity to recognize the importance of digital ways of work including eCTD implementation, without ignoring the different challenges and numerous advantages.

Learning Objective :
  • Recognize eCTD's foundational significance and assess its adaptability and inherent limitations amidst rapid technological advancements in the cloud era
  • Identify how cloud platforms can address eCTD's limitations, fostering enhanced information

Speaker(s)

Representative Invited

eCTD in a Cloud Era: Evolution, Integration, and the Future of Regulatory Submissions

Representative Invited

Merck Serono Limited, United Kingdom

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