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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
Regional Regulatory Policy LATAM Region, Global International Regulatory Policy
Productos Roche S.A. DE C.V., Mexico
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)
Facilitating Access to Innovation in LATAM Regulatory Landscape
Rocio Beneitez
Novartis Pharma Logistics, Inc., Guatemala
Regional Regulatory Affairs Head of New Product Strategy (LACan)
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
Canadian Regulatory Framework for Cell and Gene Therapies
Omar Tounekti, PhD, MBA
Health Canada, Canada
Acting Director, Centre for Oncology, Radiopharmaceuticals and Research
Speaker
Eva Maria Ruiz de Castilla, PhD, MSc
Latin America Patients Academy, United States
Executive Director