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Overview

Meeting:
Day One: March 6 – 10:00AM-4:00PM
Day Two: March 7 – 10:00AM-4:30PM
Day Three: March 8 - 10:00AM-4:30PM

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

DIA is thrilled to announce our 2023 Latin America Annual Meeting (formerly known as Latin America Regulatory Conference) that will include opportunities for networking and knowledge sharing with key stakeholders influencing the advancement and implementation of initiatives in Latin America and the Caribbean. This new meeting expands in scope from our previous meetings discussing topics relating to the Latin America region, and presents the following three tracks: Regulatory, Clinical and Pharmacovigilance. Cross-track sessions provide the opportunity to discuss key connection points across major components of regulatory, clinical and pharmacovigilance initiatives, efforts and collaboration within these functional areas in an organization or company. Join us to discuss multi-regional cooperation, global harmonization, lessons learned, and best practices to stimulate discussion and foster collaboration amongst stakeholders in Latin America and the Caribbean.

Registered attendees will receive access to all session recordings for 2 full months post-conference! This allows you to remain flexible with your schedule and not worry if you need to miss a session. Have a conflict with the dates of the conference? Register anyway and you will receive access to the recordings!

Need approval in order to attend? Download and fill out our Justification Letter to demonstrate to your supervisor why this is a must-attend event.

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Who should attend?

  • Meeting Designed For:

    • Academia
    • Benefit-Risk Assessment and Communication
    • Clinical Research and Development
    • Clinical Operations
    • CROs/Vendors
    • Drug Regulation
    • Drug Safety/Pharmacovigilance
    • Global Submission/Project Management
    • Government Affairs
    • Manufacturing
    • Medical and Scientific Affairs
    • Medical Communication
    • Medical Information
    • Medical Product Safety Assessment
    • Pharmacoepidemiology
    • Policy and Intelligence
    • Post-Market Studies
    • Quality Assurance and Compliance
    • Real-World Evidence
    • Regulatory Agencies
    • Regulatory Affairs, Operations, and Strategy
    • Research and Development
    • Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
    • Strategic Sourcing/Planning
  • Learning Objectives:

    • Recognize the evolution of regulatory systems and its impact on healthcare in Latin America
    • Define future perspectives, challenges, and opportunities for the regulation of biopharmaceuticals in Latin America
    • Describe current drug safety and pharmacovigilance rules and processes, regulatory trends, and expectations for compliance
    • Recognize the importance of good regulatory practices for strengthening and improving the performance of sustainable regulatory systems
    • Analyze opportunities for interaction with HAs and possibilities for joint communication strategies centered around the patient
    • Share trends and case of studies on effective reliance practices in the region and discuss major remaining obstacles and recommend a path forward
    • Follow the implementation of strategies and plans to strengthen the regulatory systems and guarantee access to medical devices, in vitro diagnostics and other related medical products
    • Discuss trends on general collaboration and convergence in the region while exploring ICH implementation in Latin America
    • Recognize the importance of input from patients for effective decision-making strategies for pharmacovigilance
    • Identify the different regulatory strategies on ICH Q12 implementation, based on local regulatory environments and complexities
    • Describe the different aspects of digital health technology (DHT) standards and technical guidance in Latin America
    • Discuss the value of different sources of pharmacovigilance data for signal detection and effectiveness measures of risk minimization strategies
    • Develop multidisciplinary regulatory strategies considering emerging regulatory pathways (e.g., orphan drug and accelerated pathways) that allows for sustainable access in Latin America
    • Identify the market dynamics of medical devices, combination products, and wearables in Latin America
    • Register



      Welcome Video in English

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      Welcome Video in Spanish

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      Program Committee

      • Fernanda  Lessa, MBA, MPH
        Fernanda Lessa, MBA, MPH Health Regulatory Systems
        Consultant, Switzerland
      • Viktoria  Magyar, LLM, MSc
        Viktoria Magyar, LLM, MSc Student
        USC School of Pharmacy, United States
      • Maria Antonieta Tony Roman, MPharm
        Maria Antonieta Tony Roman, MPharm Head Regulatory Policy Emerging Markets LATAM
        Novartis, Mexico
      • Leonardo  Semprun, RPh
        Leonardo Semprun, RPh Senior Director, Global Regulatory Policy LATAM
        MSD, Panama
      • 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
      • Flavia  Firmino Ribeiro
        Flavia Firmino Ribeiro Director Reg Global CMC
        Pfizer, Brazil
      • Gislaine  Dib, PharmD
        Gislaine Dib, PharmD Pharmacovigilance Manager
        PGA Farma, Brazil
      • Raphael Elmadjian Pareschi, MBA
        Raphael Elmadjian Pareschi, MBA Patient Safety Lead/ Head of Pharmacovigilance Brazil
        Roche, Brazil
      • Rosana Miguel Messias Mastellaro, PharmD, RPh
        Rosana Miguel Messias Mastellaro, PharmD, RPh Director of Regulatory Affairs
        Sindusfarma, Brazil
      • Bianca  Passos, PharmD, MBA
        Bianca Passos, PharmD, MBA Country Safety Head - Brazil
        Sanofi, Brazil
      • Michelle  Arguelles Gonzalez, RPh
        Michelle Arguelles Gonzalez, RPh Executive Director, Clinical Research
        Merck Sharp & Dohme (MSD), Mexico
      • Duglas  Rodriguez Calderon, MSc
        Duglas Rodriguez Calderon, MSc Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence
        Roche, Panama
      • Lorena  Larrosa
        Lorena Larrosa Regulatory Affairs Manager
        Abbvie, Uruguay
      • Susan  Koepke, MBA
        Susan Koepke, MBA Head of Regulatory Affairs LATAM
        EMD Serono, Inc. , Healthcare Business of Merck Kgaa, Darmstadt, Germany., United States
      • Patricia  Pineda, MSc
        Patricia Pineda, MSc International Regulatory Analyst, OIP, OGROP, OC
        FDA, United States
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