Donate Now Become a member

Cart (0)

Already a DIA Member? Sign in. Not a member? Join.

Not a Member?

Create Account and Join

DoubleTree by Hilton Grand Biscayne Bay

Feb 21, 2019 7:00 AM - Feb 22, 2019 5:00 PM

1717 N Bayshore Drive, Miami, FL 33132

Latin America Regulatory Conference

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

Back to Agenda

Session 8: CTD for Registration Purposes in LATAM

Session Chair(s)

Peter Baker

International Relations Specialist, OIP, OGROP

FDA, United States

This session is intended to provide an overview of both the challenges and advantages of using the Common Technical Document (CTD) for product registration purposes, and will involve unique perspectives from the regulator and industry. The session will culminate in a panel discussion where you can request additional clarification for points addressed, or request additional information that might not have been covered.

Learning Objective : At the completion of this session, participants should be able to:
Understand the basic structure of the CTD
Hear some of the challenges faced by both regulators and industry in implementation of the CTD
Hear some of the advantages noted by both regulators and industry in implementation of the CTD
Understand how the CTD will be used in the future (anticipated trends)

Speaker(s)

CTD for Registration Purposes – An Industry Perspective

Juliana Schwarz Rocha

NG Reis Consultoria, Brazil

Regulatory Affairs Consultant

CTD for Registration Purposes – A Regulator’s Perspective

Ana Carolina Moreira Marino Araujo, PharmD

ANVISA, Brazil

Head of the International Affairs Office

CTD for Registration Purposes – Anticipated Future Trends

Yvonne Lozano

AbbVie, United States

Senior Director QA Audit and Compliance

Have an account?