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

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Mar 06, 2023 10:00 AM - Mar 08, 2023 4:30 PM

(US Eastern Standard Time)

Latin America Annual Meeting

Latin America Annual Meeting is fully virtual. Join us from the comfort of your own space!

Session 9, Track A: How to Keep Pace with the Advancement of Innovation and Emerging Technologies while Safeguarding Patients

Session Chair(s)

Urimara  Argotti-Rodriguez, MBA

Urimara Argotti-Rodriguez, MBA

Regional Regulatory Policy LATAM Region, Global International Regulatory Policy

Productos Roche S.A. DE C.V., Mexico

Susan  Koepke, MBA

Susan Koepke, MBA

Head of Regulatory Affairs LATAM

EMD Serono, Inc., United States

This session will discuss emerging global regulatory pathways and insights for the implementation of a successful regulatory strategy plan accompanied by molecule access in the healthcare system. Topics in this session include innovative therapies (e.g., advanced therapy medicinal products [ATMPs] and cell and gene therapy), orphan drugs, and the need of the enhancement of a regulatory framework to foster innovation without prejudice of the patient’s safety.

Learning Objective :
  • Identify critical factors influencing the evolution of the regulatory landscape and access to emerging technology
  • Develop multidisciplinary regulatory strategies considering emerging regulatory pathways (e.g., orphan drug and accelerated pathways) that allows for sustainable access in Latin America
  • Foster development of a regulatory framework for innovative therapies such as advanced therapy medicinal products (ATMPs), cell and gene therapy

Speaker(s)

Rocio  Beneitez

Facilitating Access to Innovation in LATAM Regulatory Landscape

Rocio Beneitez

Novartis Pharma Logistics, Inc., Guatemala

Regional Regulatory Affairs Head of New Product Strategy (LACan)

Diana  Tellez, DrMed, MPH

Facilitating Access to Innovation in LATAM / Practical Pragmatic Approaches. Access and Reimbursement

Diana Tellez, DrMed, MPH

Merck Group, Colombia

Director Market Access and Pricing Operations LATAM

Omar  Tounekti, PhD, MBA

Canadian Regulatory Framework for Cell and Gene Therapies

Omar Tounekti, PhD, MBA

Health Canada, Canada

Acting Director, Centre for Oncology, Radiopharmaceuticals and Research

Eva Maria  Ruiz de Castilla, PhD, MSc

Speaker

Eva Maria Ruiz de Castilla, PhD, MSc

Latin America Patients Academy, United States

Executive Director

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.