Overview

Conference: March 14-16

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.

DIA brings you a conference with interactive dynamics, where you will be engaged in discussions with key stakeholders influencing the advancement and implementation of regulatory convergence initiatives in Latin America.

Join us to discuss multi-regional cooperation, global harmonization, and best practices related to Latin America’s regulatory landscape. Sessions will highlight regulatory approaches and good practices to ensure reliance in Latin American and strategic initiatives to improve collaboration and cooperation.

*The primary language is English, however simultaneous interpretation in Spanish and Portuguese will be available during this Conference.

On-Demand Webinar

Forward-Looking to DIA LARC 2022: Insights from CECEMED and Leveraging Lessons Learned from COVID-19

Thursday, February 10, 2022 | 11:00 – 12:00PM ET
DIA’s Latin America Regulatory Conference (LARC) 2022 virtual Promotional Webinar will provide highlights of the key regulatory concepts and discussions initiatives of theto be discussed at DIA’s LARC 2022 3-day conference occurring held on March 14- to 16, 2022. Gain an insider’s view as to what will be discussed at LARC 2022 with a Sspecial focus will be on Cuba's National Regulatory Authority (NRA), Center for State Control of Medicines, Equipment and Medical Devices (Spanish acronyms CECMED). The Promotional Webinar will touch on lessons learned from the pandemic to achieveing a greater regulatory agility and emergency preparedness in the Latin American region.

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Who should attend?

Professionals involved in:

Academia
Clinical Research and Development
CROs/Vendors
Global Submission/Project Management
Government Affairs
Medical and Scientific Affairs
Policy and Intelligence
Quality Assurance and Compliance
Regulatory Agencies
Regulatory Affairs, Operations, and Strategy
Research and Development
Strategic Sourcing/Planning

Learning objectives

At the conclusion of this activity, participants should be able to:

Distinguish main actions and best practices implemented by health authorities in Latin America and the Caribbean
Identify current and future regulatory projects and priorities from regulators in the region
Identify main concepts and uses of Good Regulatory Practices and Good Reliance Practices
Distinguish the concepts of NRAs of regional reference and of WHO Listed Authorities and identify the roles and responsibilities of reference authorities in the context of the ongoing efforts in strengthening regulatory systems in the Americas
Distinguish main actions and best practices implemented by the NRArr from Latin America in the past year and lessons learned from COVID-19
Identify the opportunities offered by convergence in favor of improving transparency and alignment between agencies and industry
Identify best practices and examples of implementation of risk-based approaches and outline opportunities for the expansion of these approaches in Latin America and the Caribbean
Recognize the differences and describe the processes between an emergency use authorization and a full approval
Describe important areas for future development within the medical device industry and recognize the regulatory challenges of medical device registration before and during the pandemic
Describe traceability and labeling information importance, the synergies supporting regulatory system strengthening, and post-marketing surveillance
Describe the WHO mRNA vaccines guideline and discuss learnings and opportunities in the Latin America region with respect to vaccines
Recognize the global and regional regulatory landscape to address rare diseases, identify the unique features and main challenges of cell/gene therapy, and describe the use of RWD and RWE for regulatory decision-making applicable to orphan drugs and advanced therapies

Program Committee

Maria Guazzaroni Jacobs, PhD Director, Quality Intelligence, Global Supply
Pfizer Inc, United States
Maria Cristina Mota Pina, MBA Head, Regulatory Policy for Emerging Markets -Japan and Australia
AbbVie, United States
Fernanda Lessa, MBA, MPH Health Regulatory Systems
Consultant, Switzerland
Viktoria Magyar, LLM, MSc Doctoral Student, Department of Regulatory and Quality Sciences
USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, United States
Roberta Mele Mazza, RPh, RAC Q&RA Manager, División Diagnóstica
Productos Roche , Argentina
Gustavo Mendes Lima Santos, MPharm Herbal and Complementary Medicines Office - GMESP
Brazilian Health Regulatory Agency (ANVISA), Brazil
Maria Antonieta Tony Roman, MPharm Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Leonardo Semprun, PharmD Global Regulatory Policy Lead-LatAm
MSD, Panama
Sonia Viejobueno, LLM Associate Director, Regulatory Policy LATAM
Johnson & Johnson Innovative Medicine, Argentina
Susan Zavala Coloma, MS, RPh Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
DIGEMID, Peru
Cammilla Horta Gomes, MA, MPharm Latam Regulatory Policy Lead
Roche, Brazil