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6th Latin American Regulatory Conference (LARC) 2014

May 14 2014 9:00AM - May 15 2014 6:15PM | Miami Marriott Biscayne Bay 1633 North Bayshore Drive Miami, FL 33132

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Overview 

Join Global Regulators, Industry and Academia to Engage in Strategic Discussion on the Current Regulatory Landscape, Future Research and Drug Development in Latin America.

Based on the success of previous LARCs since the conference’s inception in 2009, DIA will continue to present this dynamic symposium involving key stakeholders to influence the advancement of regulatory convergence initiatives within Latin America.

NEW! Help Shape the Conference Discussions!
Once you register you will receive preconference communications and instructions on how to send your questions for speakers in advance of the conference. Get ready to join the discussions during the interactive panel sessions!

Simultaneous Translation will be available in English and Spanish. / Traducción Simultánea en inglés y en español.

Únase al grupo selecto de académicos y oficiales de las agencias reguladoras de la región; participe en conversaciones estratégicas sobre el panorama regulatorio actual; así como sobre el futuro de la investigación y desarrollo de medicamentos en América Latina.

Con base en el éxito y la calidad de las pasadas cinco Conferencias Regulatorias de América Latina (LARC), celebradas en Chile, México, Panamá, y más recientemente en Colombia, la DIA le trae un simposio con nuevas dinámicas interactivas, donde los participantes tendrán oportunidad de tratar directamente con los actores que influyen en el avance e implementación de las iniciativas de convergencia de regulación en América Latina.

El único foro verdaderamente imparcial y neutral para todos los actores del sector farmacéutico de la región.
¡NUEVO! !Prepárese para participar dentro de las sesiones!

Una vez registrado, recibirá comunicaciones previas a la conferencia e instrucciones sobre cómo enviar sus preguntas a los oradores antes de la conferencia. ¡Prepárese para participar en las sesiones interactivas!

Para descargar el programa en español dar click aquí.

Featured Topics 

  • Regulatory Landscape and Regulatory Convergence Framework; Red PARF/VII PANDRH Discussions
  • New Regulatory Approaches and Initiatives
  • Multi-regional Clinical Trials (MRCTs)
  • Drug Safety, Marketing Surveillance, and Quality Control Monitoring
  • Health Systems and Security of the Supply Chain: Traceability and Counterfeit Medicines
  • Biologics and Biosimilars Regulations: Industry and Regulatory Agency Perspectives
  • Emerging Topics

Who Should Attend 

This program will benefit individuals involved in:

  • Drug regulation
  • Clinical research and development
  • Clinical safety and pharmacovigilance
  • Clinical trial and project management
  • Drug development and discovery
  • Medical and scientific affairs
  • Preclinical development
  • Quality assurance
  • Research and development
  • Strategic sourcing/planning
  • Regulatory affairs

Learning Objectives 

  • Define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America
  • Discuss the progress of the PANDRH Convergence process and the current working groups

Hotel & Travel 

TRAVEL AND HOTEL
The most convenient airport is Miami International Airport (MIA) and attendees should make airline reservations as early as possible. A limited number of rooms are available at Miami Marriott Biscayne Bay: 1633 North Bayshore Drive, Miami, FL 33132, at the reduced rate shown below (rate is guaranteed until April 21, 2014, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel. Contact information for Travel Planners is as follows: Attendees can follow this link or call +1.212.532.1660 or 1.800.221.3531 in the USA. When making your hotel reservation by phone, please select option 1 for “Hotel Reservations” and inform the phone agent that you are making a reservation for the Latin American Regulatory Conference (Event #14825).

Standard Room Rate: $159
Upon request, DIA can issue supporting letters for attendees who paid registration to get a USA visa. Please contact Alejandro.Bermudez@diahome.org.

VIAJE Y ACOMODACIONES
El aeropuerto cercano más conveniente es el Aeropuerto Internacional de Miami (MIA). Se les exhorta a hacer sus planes de viaje lo más pronto posible. DIA ha bloqueado un número limitado de habitaciones bajo tarifa especial (con descuento) en el hotel Miami Marriott Biscayne Bay: 1633 North Bayshore Drive, Miami, FL 33132. Esta tarifa (al calce) está garantizada hasta el día 21 de abril de 2014 (o hasta que se haya acabado la disponibilidad de habitaciones). Nota: para recibir la tarifa con descuento por favor contactar a Travel Planners y no directamente con el hotel. Información de contacto de Travel Planners: click en el  vinculo or llamar teléfono +1.212.532.1660 o 1.800.221.3531 en los EE.UU. Al hacer su reserva de hotel por teléfono, por favor seleccione la opción 1 para “Reservas de Hoteles” e informar el agente telefónico que usted está haciendo una reserva en la Latin American Regulatory Conference (Evento # 14825).

Standard Room Rate: $159
En caso de ser necesario, DIA proporcionará cartas de recomendación, para facilitar la obtención de una Visa de entrada a los EEUU a los participantes que hayan cubierto su cuota de inscripción y que así lo soliciten. Favor de contactar a: Alejandro.Bermudez@diahome.org.

Contact Information 

Mr. Alejandro Bermudez-Del-Villar, MA/IBBD
Latin American and Global Development Coordinator
Alejandro.Bermudez@diahome.org

LETTER TO SUPPORT YOUR US VISA APPLICATION
DIA can provide a confirmation letter for you for this conference so long as you have: a) already registered for this conference and b) paid the registration for this conference. To request a confirmation letter please send an email to Alejandro Bermudez Del Villar.

Para descargar el programa en español dar click aquí. 

Program Committee 

Previous Next

Agenda  

Day 1 Wednesday, May 14, 2014

  • 9:00AM - 9:30AM

    Welcome and Opening Comments

    Speaker(s):

    • Susan Cantrell, RPh
      Senior Vice President and Managing Director, DIA Americas
      DIA, United States
    • Welcome and Opening Comments
      Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States
    • Welcome and Opening Comments
      Sergio Guerrero, MD
      Chair, DIA Advisory Council for Latin America
      President/CEO, Accelerium Clinical Research, Mexico
  • 9:30AM - 10:00AM

    Keynote

    Speaker(s):

    • The Situation of Infectious Diseases in the Latin American Region
      Ricardo Walter Rüttimann
      Director, Vaccines Division
      Fighting Infectious Diseases in Emergent Countries(FIDEC-FUNCEI), United States
  • 10:30AM - 12:30PM

    Session 1: Updates on Regional and Global Convergence


    Session Chair(s):

    • Mike Ward
      Manager, International Programs Division
      Health Canada, Canada

    This panel session will provide an interactive dialogue forum to update and review topics on strategic planning stemming from the PAHO’s VII Pan American Network for Drug Harmonization (PANDRH)/Red PARF, which took place in Canada on September 5-7, 2013. This session will also cover information on the WHO/ICDRA (International Conference of Drug Regulatory Agencies) Meeting and Pre-ICDRA Conference, to take place in Rio de Janeiro, Brazil in August 2014.

    Speaker(s):

    • Introduction
      Mike Ward
      Manager, International Programs Division
      Health Canada, Canada
    • Regional Overview and the Regional Platform on Access and Innovation for Health Technologies (PRAIS)
      Jose Daniel Peña Ruz
      Regional Advisor, Medicines and Health Technologies
      Pan American Health Organization (PAHO)/World Health Organization (WHO), Chile
    • World Health Organization’s Perspective
      Lembit Rago, MD, PhD
      Head, Regulation of Medicines and other Health Technologies
      World Health Organization (WHO), Switzerland
    • Interactive Discussions with Panelists and the Audience
      Maria Guazzaroni Jacobs, PhD
      Director, Quality and Regulatory Policy (QRP)
      Pfizer Inc., United States
  • 1:30PM - 3:30PM

    Session 2: Discussion on New Regulatory Approaches and Initiatives


    Session Chair(s):

    • Beatriz Luna
      Director, Medicines Department
      Ministry of Public Health, Uruguay

    This panel is devoted to analyze and discuss innovative regulatory approaches that agencies in the Latin American region have used to support and help advance the pharmaceutical and Medical devices Industry in the region.

    Speaker(s):

    • ANVISA/Brazilian Initiatives
      Silmara Cristiane da Silveira Andreoli
      Especialista em Regulação e Vigilância Sanitária
      ANVISA, Brazil
    • Introduction
      Beatriz Luna
      Director, Medicines Department
      Ministry of Public Health, Uruguay
    • FDA Initiatives
      Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States
    • Colombian Initiatives
      Claudia Vaca, MD
      Senior Advisor, Medicines
      Ministry of Public Health and Social Protection, Colombia
    • Interactive Discussions with Panelists and the Audience
      Cristina Alonso Alija, PhD
      Bayer Healthcare Pharmaceuticals Inc., United States
  • 3:45PM - 6:00PM

    Session 3: Integrity of the Supply Chiain and Global Product Quality


    Session Chair(s):

    • Mike Ward
      Manager, International Programs Division
      Health Canada, Canada

    Latin American markets have become more vulnerable to and negatively impacted by the international movement of spurious, substandard, falsified, falsely-labeled and counterfeit (SSFFC) medical products. This session will focus on the region’s efforts and initiatives to ensure that the trade in legitimate products is not disrupted. Specific areas to be discussed, include, but are not limited to, a) good distribution practices, b) controls on components used as part of good manufacturing practices and quality management systems, c) import and export practices, d) dispensing practices via the Internet, e) detection technologies, among others.

    Speaker(s):

    • Introduction
      Mike Ward
      Manager, International Programs Division
      Health Canada, Canada
    • Traceability in Brazil
      Jésica Carino
      Fiscalizadora, Programa Nacional de Control de Mercado de
      Medicamentos y Productos Médicos, ANMAT, Argentina
    • Guatemalan Regulation on Counterfeit Medicines
      Raul Mendoza Paredes
      Coordinator, Legal & Technical Unit
      Ministry of Public Health and Social Assistance, Guatemala
    • Update on RX360
      Anthony Zook, PharmD
      Senior Project Manager, Counterfeits Management
      Merck and Co., Inc., United States

Day 2 Thursday, May 15, 2014

  • 9:00AM - 11:00AM

    Session 4: Panel Discussion: Multi-regional Clinical Trials (MRCTs)


    Session Chair(s):

    • Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States

    This session is devoted to discuss specifics on the value and potential benefits of MRCTs. Participants from regulatory agencies, the pharmaceutical industry, and academia will come together to identify issues and make recommendations for resolving major challenges with the aim of improving the capacity of the Latin American region to carry out MRCTs.

    Speaker(s):

    • Introduction
      Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States
    • Ecuadorian Perspective
      Cesar Masache, MD
      Head, National System on Pharmacotherapy & Pharmacovigilance
      Ministry of Public Health, Ecuador
    • From Compliance to Compentency: Core Compentencies for the Clinical for the Clinical Research Professional
      Stephen Sonstein, PhD
      Director, Clinical Research Administration
      Eastern Michigan University, United States
    • Interactive Discussions with Panelists and Audience
      Vitor Harada, MBA, RPh
      Senior Director, Clinical Site Monitoring
      Quintiles, Brazil
  • 11:20AM - 12:20PM

    Session 5A: Industry Perspective on Biotherapeutics & Biosimilar Products


    Session Chair(s):

    • Thomas Kirchlechner, PhD
      Head, Regulatory Emerging Markets
      Sandoz Biopharmaceuticals Development (Novartis), Austria

    This panel session aiming at providing an all-encompassing perspective on the Biotherapeutics and Biosimilar products fi eld. As such, the session has been divided into two sections. The first one includes perspectives by industry experts, while the second is comprised by a panel of regulatory agencies officials specialized in the topic. A dynamic and interactive panel discussion with the audience will take place at the end of the second section for all stakeholders to visit on the multiple views provided by the panelists.

    Speaker(s):

    • Introduction /Biosimilar Monoclonal Antibodies and Advanced Therapies
      Thomas Kirchlechner, PhD
      Head, Regulatory Emerging Markets
      Sandoz Biopharmaceuticals Development (Novartis), Austria
    • Biosimilar Products in Brazil
      Edilson Uiechi, DVM
      Libbs, Brazil
    • Regional and Global Perspective
      Ana Padua, MSc
      Latin America DRA Manager & Policy
      Roche, Brazil
  • 1:20PM - 3:45PM

    Session 5B: Regulatory Agencies Perspective on Biotherapeutics & Biosimilar Products


    Session Chair(s):

    • Hans Vasquez, MD
      Clinical Review Coordinator
      Dirección General de Medicamentos Insumos y Drogas (DIGEMID) , Peru

    Session 5B: Regulatory Agencies Perspective on Biotherapeutics & Biosimilar Products

    Speaker(s):

    • Introduction
      Hans Vasquez, MD
      Clinical Review Coordinator
      Dirección General de Medicamentos Insumos y Drogas (DIGEMID) , Peru
    • Argentinean Perspective
      Patricia Aprea, MD
      Director, Drug Evaluation Agency
      ANMAT, Argentina
    • Brazillian Perspective
      Silmara Cristiane da Silveira Andreoli
      Especialista em Regulação e Vigilância Sanitária
      ANVISA, Brazil
    • Mexican Perspective
      Francisco García Zetina
      Director Ejecutivo De Autorización de Productos y Establecimientos
      COFEPRIS, Mexico
    • Columbian Perspective (via TC)
      Claudia Vaca, MD
      Senior Advisor, Medicines
      Ministry of Public Health and Social Protection, Colombia
    • Interactive Discussions with Panelists and Audience
      Thomas Kirchlechner, PhD
      Head, Regulatory Emerging Markets
      Sandoz Biopharmaceuticals Development (Novartis), Austria
    • Interactive Discussions with Panelists and Audience
      Hans Vasquez, MD
      Clinical Review Coordinator
      Dirección General de Medicamentos Insumos y Drogas (DIGEMID) , Peru
  • 4:00PM - 5:00PM

    Session 6: Interactive Panel on Transparency and Good Review Practices (GRPs)


    Session Chair(s):

    • Mike Ward
      Manager, International Programs Division
      Health Canada, Canada

    This session will discuss the current efforts on transparency and good review practices as regulatory agency’s ways to improve their performance and ensuring the quality of the regulatory systems in place. Presentations will focus on the World Health Organization’s Draft Guidance on GRPs; Global Transparency reviews, CTDs, Regulatory Cooperation, among other topics.

    Speaker(s):

    • Global Regulatory Cooperation and Transparency
      Justina A. Molzon, JD, MSc, RPh
      Associate Director for International Programs, Office of Strategic Program CDER
      FDA, United States
    • Good Review Practices
      Sabine Kopp, PhD
      Quality Assurance and Safety: Medicines Essential Medicines and Health Products
      World Health Organization, Switzerland
    • Good Review Practices
      Prisha Patel, MSc
      Manager, Emerging Markets Programe
      Centre for Innovation in Regulatory Science (CIRS), United Kingdom
    • Interactive Discussion with Panelists and Audience
      Anthony Ventura
      Head of Latin America Region, Worldwide Regulatory Strategy - International
      Pfizer Inc., United States
  • 5:00PM - 6:00PM

    Plenary Session: Special Planning Session for the 7th DIA Latin American Regulatory Conference (LARC)

    Speaker(s):

    • Plenary Session: Special Planning Session for the 7th DIA Latin America Regulatory Conference (LARC)
      Sergio Guerrero, MD
      Chair, DIA Advisory Council for Latin America
      President/CEO, Accelerium Clinical Research, Mexico
    • Plenary Session: Special Planning Session for the 7th DIA Latin America Regulatory Conference (LARC)
      Alejandro Bermudez-del-Villar, MA
      Project Coordinator, Latin America and Global Program Development
      DIA, United States
  • 6:00PM - 6:15PM

    Closing Remarks and Conference Adjourned

    Speaker(s):

    • Closing Remarks and Conference Adjourned
      Sergio Guerrero, MD
      Chair, DIA Advisory Council for Latin America
      President/CEO, Accelerium Clinical Research, Mexico

Registration Fees 

Other Fees

Charitable Nonprofit/Academia
$855.00
Government (Full Time)
$652.00
Non-LA Industry EB (Members save $390 at checkout)
$1790.00

Member

Latin America Industry (Members)
$1075.00

Non-Member

Latin America Industry (Non-members)
$1250.00
Group Discounts

There are no group discounts for this event.


Join DIA now to qualify to save on future events and to receive all the benefits of membership.

CANCELLATION POLICY: On or before APRIL 4, 2014, Administrative fee that will be withheld from refund amount:

  • Member or Nonmember = $200
  • Government or Academia or Nonprofit (Member or Nonmember) = $100

Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

CANCELACIONES (ANULACIONES): Hasta el día 4 de ABRIL, 2014, Cuota de gastos administrativos a ser retenida:

  • Miembros o No Miembros = USD$200
  • Académicos, oficiales gubernamentales u organizaciones sin fines de lucro = USD$100

Las Cancelaciones se deben de realizar en forma escrita hasta la fecha indicada. Después de la fecha indicada no se realizarán reembolsos y se retendrá la cantidad pagada. Igualmente, las cancelaciones de hotel y aerolíneas son responsabilidad del asistente. Es Posible transferir el registro a otro colega, excepto el pago por membresía, que no es transferible. Favor de notificar a DIA de cualquier cambio con suficiente anticipación.
DIA se reserva el derecho de cambiar el lugar del evento si es necesario.

Si el evento es cancelado, DIA no se hace responsable por gastos de hotel, avion u otros gastos incurridos como preparación para su asistencia al evento.

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