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 14, 2022 10:00 AM - Mar 16, 2022 3:15 PM

(US Eastern Standard Time)

Latin America Regulatory Conference

DIA Your Way! Join us virtually from the comfort of your home/office March 14-16 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 3: Regulatory Convergence and Collaboration

Session Chair(s)

Roberta  Mele Mazza, RPh, RAC

Roberta Mele Mazza, RPh, RAC

Q&RA Manager, División Diagnóstica

Productos Roche , Argentina

Leonardo Semprun Semprun, RPh

Leonardo Semprun Semprun, RPh

Global Regulatory Policy Lead-LatAm

MSD, Panama

Regulatory convergence takes many forms and represents an effort to improve the transparency and alignment of interactions between agencies and the industry regarding scientific principles, practices and procedures, as reflected in the acceptance of internationally recognized technical guidance documents and implementation of regulatory mechanisms that align with them. The purpose of this session is to bring together representatives of global regulatory bodies, industry and academia who are directly involved in the management of the regulatory process to exchange knowledge and experiences on the evolving regulatory environment of medical products regarding initiatives of convergence, both regional and international agencies, and understand how it helps streamline the regulatory process to facilitate the achievement of public health goals.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize trends on general collaboration for better convergence in the region and other international agencies
  • Identify the opportunities offered by convergence in favor of improving transparency and alignment between agencies and industry
  • Assess challenges and lessons learned about convergence initiatives in the region

Speaker(s)

Lawrence  Liberti, PhD, RAC

Opportunities for Greater Convergence in Latam

Lawrence Liberti, PhD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

Martin  Harvey Allchurch, LLM

Overview - Medicines Assessed Under the ‘EU-M4all’ Procedure

Martin Harvey Allchurch, LLM

European Medicines Agency, Netherlands

Head of International Affairs

Gustavo  Mendes Lima Santos, MPharm

Lessons Learned from Collaboration and Convergence Initiatives

Gustavo Mendes Lima Santos, MPharm

Brazilian Health Regulatory Agency (ANVISA), Brazil

Herbal and Complementary Medicines Office - GMESP

Heriberto Enrique García Escorza, MPA, RPh

Agency Lessons Learned from Collaboration and Convergence Initiatives

Heriberto Enrique García Escorza, MPA, RPh

Instituto de Salud Pública de Chile, Chile

Director

Angelika  Joos, MPharm

Regulatory Convergence - Industry Perspective (Medicines)

Angelika Joos, MPharm

MSD, Belgium

Executive Director, Global Regulatory Policy

Sandra Ligia González Aguirre

Regulatory Convergence - Industry Perspective (Medical Technology)

Sandra Ligia González Aguirre

Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States

Executive Secretary, Inter-American Coalition for Regulatory Convergence

Miriam Jackeline Jackeline Loera Rosales

Speaker

Miriam Jackeline Jackeline Loera Rosales

COFEPRIS, Mexico

International Affairs 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.