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11th Latin American Conference of Clinical Research

Sep 25 2014 8:00AM - Sep 26 2014 6:30PM | CINTERMEX Convention Center Av. Fundidora No. 501 - Col. Obrera N.L. Monterrey 64010 Mexico

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Overview 

Simulatneous Translation will be available in English and Spanish

Meet with global and regional clinical researchers, industry, and academia professionals to engage in interactive strategic discussions on current clinical research and medical devices regulations and polices, and implementation approaches to future research around the world and in Latin America.

DIA’s 11th LACCR is the top regional academic forum on clinical research in Latin America. LACCR is the only neutral forum in the region aimed at fostering the integration of professionals in the field, aiming to fully develop Latin America’s potential in the scope of clinical research globally. The two-day conference will feature presentations on hot topics ranging from global issues to focusing on specific details of clinical research and medical devices. Speakers will highlight the most relevant issues for the Latin American region in regulatory, pharmacoeconomy, ethics, a clinical site’s infrastructure, the components of clinical research, and much more.

Please visit our registration site which has registration and hotel information

To register/Registro.

Featured Topics 

  • Clinical research sites issues
  • Pharmaco-economy topics
  • Ethics in clinical research
  • Scientific issues
  • Regulatory updates
  • Generic products
  • Integration of the supply chain industry components
  • Excellence in education and training
  • Medical devices
  • Stakeholders’ role and active participation in the industry

Who Should Attend 

  • Research professionals: clinical, laboratory, site members, and CRAs
  • CROs and SMOs
  • Service providers
  • Clinical investigators (active and potential)
  • Ethics committees
  • Regulatory agencies
  • Medical education institutions and associations
  • Pharmaceutical sponsors
  • Other professionals considering initiating their activities in this professional area
  • Regulatory affairs professionals
  • Supply chain industry professionals

Learning Objectives 

  • Manage the different phases of a sponsored trial, providing guidance and leadership to the study team in order to achieve or surpass the project objectives and become competitive in the research arena
  • Understand what kind of professional development can be achieved in clinical research
  • Understand the long way from basic research to public health innovation in the clinical research arena
  • Understand the regulatory principles and procedures in clinical research and interact with the regulatory stakeholders in the region
  • Compare the Latin America opportunities with other emerging markets in clinical research

Contact Information 

Agenda Details & Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Please visit our registration site which has registration and hotel information

To register/Registro.

Program Committee 

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Agenda  

Day 1 Thursday, Sep 25, 2014

  • 8:00AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Barbara Lopez Kunz, MS
      Global Chief Executive
      DIA, United States
    • Sergio Guerrero, MD
      Chair, DIA Advisory Council for Latin America
      President/CEO, Accelerium Clinical Research, Mexico
  • 8:30AM - 9:00AM

    Transcelerate Initiatives: Goals and Implications on the Latin American Industry


    Session Chair(s):

    • Speaker Invited
      United States

    Transcelerate Initiatives: Goals and Implications on the Latin American Industry

  • 9:00AM - 10:30AM

    Plenary 1: Economic Impact of Regulations in Regional Competitiveness


    Session Chair(s):

    • No-image Wanda Dobrzanski Nisiewicz, MD
      Vice President and General Manager, Vaccines and Infectious Diseases
      inVentiv Health Clinical, Argentina
    • Gabriela Davila, MD
      Compliance Director, Latin America and Puerto Rico
      Pfizer, Mexico

    Plenary 1: Economic Impact of Regulations in Regional Competitiveness

    Speaker(s):

    • Panelist
      Pablo Viard, MD
      Regional Clinical Trials HUB Director
      Bristol-Myers Squibb, Argentina
    • Panelist
      Jose Daniel Peña Ruz
      Regional Advisor, Medicines and Health Technologies
      Pan American Health Organization (PAHO)/World Health Organization (WHO), Chile
    • Panelist
      Gabriela Davila, MD
      Compliance Director, Latin America and Puerto Rico
      Pfizer, Mexico
    • Panelist
      Patient Representative Invited
      United States
  • 11:00AM - 12:30PM

    Plenary 2: Public-Private Partnerships Fostering Educational Programs in Clinical Research


    Session Chair(s):

    • Andres Bayona, MD
      Director Clinical Management
      Asociacion Peruana para la Promocion de Investigacion Clinic, Peru

    Plenary 2: Public-Private Partnerships Fostering Educational Programs in Clinical Research

    Speaker(s):

    • Education in Clinical Research: The Latin American Experience
      Honorio Silva, MD
      President
      Inter-American Foundation for Clinical Research (IAFCR), United States
    • University Partnerships: Education in Clinical Research Centers
      Juan Luis Yrivarren, MD
      Director, Ricardo Palma Clinical Research Center, Peru
    • Core Competencies for the Global Clinical Research Professional
      Stephen Sonstein, PhD
      Director, Clinical Research Administration
      Eastern Michigan University, United States
  • 12:30PM - 1:30PM

    Plenary 3: Certification of Ethics Committee in Latin America


    Session Chair(s):

    • No-image Charles Schmidt, MD
      Head Scientific Medical Advisory Board, Prof., Santa Casa Medical
      Estern Medical CRO, Brazil

    Plenary 3: Certification of Ethics Committee in Latin America

    Speaker(s):

    • Bioethics
      Sarah H. Kiskaddon, JD, MA
      Director, Global Business Development and Public Affairs
      (AAHRP) Assn for the Accreditation of Human Research Protection Programs, United States
    • The Mexican Perspective
      Carlos Hinojosa, MD
      Deputy Director, Clinical Research
      Instituto Mexicano de Nustricion, Mexico
    • The WHO Perspective
      WHO Speaker Invited
      United States
  • 2:30PM - 3:30PM

    Plenary 4: Biobanks: Clinical and Research Applications


    Session Chair(s):

    • Hugo Alberto Barrera Saldaña, MD
      Secretario Ciencia y Tecnología / CEO
      FM-UANL / Vitaxentrum, Mexico

    Plenary 4: Biobanks: Clinical and Research Applications

    Speaker(s):

    • The University of Nuevo Leon's Biobank
      Maria de Lourdes Garza, MD
      Professor
      University of Nuevo Leon, Mexico
    • Biobanks' Applications in Clinical Research - An Example
      Speaker Invited
      United States
  • 4:00PM - 5:00PM

    Concurrent Session A: Medical Communication & Medical Science Liaison as Part of the Medical Affairs Responsibilities in Latin America


    Session Chair(s):

    • No-image Jose Luis Viramontes, MD
      Director, Clinical Management, Mexico, Central America and the Carribean
      PPD, Mexico

    Concurrent Session A: Medical Communication & Medical Science Liaison as Part of the Medical Affairs Responsibilities in Latin America

    Speaker(s):

    • Creating an Innovative Medical Information Contact Center Experience in LA
      Patricia Tortorelli, MD
      Associate Director, Medical Communications
      Pharmaceutical Product Development, Inc (PPD), Brazil
    • Medical Information Management as a Key Responsibility of the Medical Director in Pharmaceuticals: The Mexican Experience
      Rafael Bravo, MD
      Medical Director
      Novartis Mexico, Mexico
  • 4:00PM - 5:00PM

    Concurrent Session B: Ethical Monitoring in the Investigator-Research Subject Relationship in Clinical Research


    Session Chair(s):

    • Federico Ramos, MD
      President, Ethics Committee, San Jose Hospital
      Instituto Tecnologico de Estudios Superiores de Monterrey (ITESM), Mexico

    Concurrent Session B: Ethical Monitoring in the Investigator-Research Subject Relationship in Clinical Research

    Speaker(s):

    • Ethical Monitoring Tool Overview
      Federico Ramos, MD
      President, Ethics Committee, San Jose Hospital
      Instituto Tecnologico de Estudios Superiores de Monterrey (ITESM), Mexico
    • The Philosophical Perspective
      Rafael de Gasperin, PhD
      Professor
      Instituto Tecnologico de Estudios Superiores de Monterrey, Mexico
  • 5:00PM - 6:00PM

    Concurrent Session C: Application of Pharmacogenetics in Personalized Medicine


    Session Chair(s):

    • Hugo Alberto Barrera Saldaña, MD
      Secretario Ciencia y Tecnología / CEO
      FM-UANL / Vitaxentrum, Mexico

    Concurrent Session C: Application of Pharmacogenetics in Personalized Medicine

    Speaker(s):

    • Pharmacogenetics in Metabolic Diseases
      Vanessa Gonzalez, MD
      Associate Researcher
      INMEGEN, Mexico
    • The Drug Metabolism Genome
      Xavier Soberon, MD
      Director
      INMEGEN, Mexico
    • Pharmacogenetics of Pharmacokinetics Highly Variable Drugs
      Speaker Invited
      United States
  • 5:00PM - 6:00PM

    Concurrent Session D: Outsourcing Latin America: Models/Trends - A Panel Discussion


    Session Chair(s):

    • Ian Rentsch, JD
      Senior Director, Business Development and Head of Latin American Sales
      Quintiles, Argentina

    Concurrent Session D: Outsourcing Latin America: Models/Trends - A Panel Discussion

    Speaker(s):

    • Panelist
      María Eugenia Sánchez Nozari
      Regional Clinical Operations Director, Latin America
      Eli Lilly, Mexico
    • Panelist
      Carolina Carrasco
      Director, Clinical Operations
      Quintiles, Mexico

Day 2 Friday, Sep 26, 2014

  • 8:00AM - 9:30AM

    Plenary 5: Patient Role - Ethical and Legal - In the Development of Clinical Trials


    Session Chair(s):

    • Luis Mario Villela, MD
      Faculty Chair, Hematology & Cancer
      Instituto Tecnologico de Estudios Superiores de Monterrey, Mexico

    Plenary 5: Patient Role - Ethical and Legal - In the Development of Clinical Trials

    Speaker(s):

    • The Civil Society Perspective
      Marie-Charlotte Bouesseau
      Team Leader, Department of Ethics, Equity, Trade and Human Rights
      World Health Organization, Switzerland
    • The Human Rights Perspective
      Speaker Invited
      United States
    • The Government Perspective
      Speaker Invited
      United States
  • 9:30AM - 10:30AM

    Plenary 6: Aspects of Global Clinical Trials and How to Avoid Unnecessary Delays in the Supply Chain


    Session Chair(s):

    • Arturo Rodriguez Jacob
      Director
      Infinite Clinical Research, Mexico

    Plenary 6: Aspects of Global Clinical Trials and How to Avoid Unnecessary Delays in the Supply Chain

  • 11:00AM - 12:00PM

    Plenary 7: Biosimilar Products Development in Latin America: Challenges and Opportunities


    Session Chair(s):

    • José Ascencion Hernández, PhD
      Pharmacology, Basic Medical Sciences
      Instituto Tecnologico De Estudios Superiores De Monterrey, Mexico

    Plenary 7: Biosimilar Products Development in Latin America: Challenges and Opportunities

    Speaker(s):

    • Development & Regulation of Biosimilars: European Experience
      Francisco García Zetina
      Director Ejecutivo De Autorización de Productos y Establecimientos
      COFEPRIS, Mexico
    • Development & Regulation of Biosimilars: Brazilian Experience
      Laura Gomes Castanheira
      Manager of Research and Clinical Trials
      COPEM/ANVISA, Brazil
    • Standardized Preclinical Evidence and Evaluation of Biosimilars - Is It Necessary?
      Ivana Knezevic
      Department of Vaccines and Biologicals
      World Health Organization, Switzerland
  • 12:00PM - 1:00PM

    Plenary 8: Risk-based Monitoring - The Approach in Latin America


    Session Chair(s):

    • Jenny Paredes, MD
      Latin American Operations Manager
      PRA International, Mexico

    Plenary 8: Risk-based Monitoring - The Approach in Latin America

    Speaker(s):

    • The Journey of Deploying Risk-based Monitoring in a Strategic Partnership: Status and Future Perspectives
      Speaker Invited
      United States
    • Risk-based Monitoring Approach in Mexico
      Carolina Carrasco
      Director, Clinical Operations
      Quintiles, Mexico
  • 2:00PM - 3:00PM

    Plenary 9: Clinical Research Developments in the Area of Gene Therapy


    Session Chair(s):

    • Hugo Alberto Barrera Saldaña, MD
      Secretario Ciencia y Tecnología / CEO
      FM-UANL / Vitaxentrum, Mexico

    Plenary 9: Clinical Research Developments in the Area of Gene Therapy

    Speaker(s):

    • Clinical Grade Gene Therapy Drugs and Assays
      Estuardo Aguilar Cordova
      CEO
      Advantagene, United States
    • First Gene Therapy Clinical Trials in Latin America
      Agusto Rojas Martinez
      Professor, School of Medicina
      Universidad Autonoma de Nuevo Leon, Mexico
    • Legal and Regulation Issues in Gene Therapy Trials
      Speaker Invited
      United States
  • 3:30PM - 4:30PM

    Concurrent Session E: Connecting the Right Sites to Promising Trials: The Next Generation of Feasibility Analyses


    Session Chair(s):

    • No-image Gustavo Kesselring, MD
      Executive Director
      Vis Research, Brazil

    Concurrent Session E: Connecting the Right Sites to Promising Trials: The Next Generation of Feasibility Analyses

    Speaker(s):

    • Panelist
      Otis Johnson
      Executive Director, Global Feasibility & Clinical Informatics
      Inventiv Health, Inc., United States
    • Panelist
      Luis Mario Villela, MD
      Faculty Chair, Hematology & Cancer
      Instituto Tecnologico de Estudios Superiores de Monterrey, Mexico
    • Panelist
      Juan Luis Yrivarren, MD
      Director, Ricardo Palma Clinical Research Center, Peru
  • 3:30PM - 4:30PM

    Concurrent Session F: Phase I Clinical Trials: The Latin American Experience


    Session Chair(s):

    • Nata Menabde
      Representative to India
      WHO, India

    Concurrent Session F: Phase I Clinical Trials: The Latin American Experience

  • 4:30PM - 5:30PM

    Concurrent Session G: Current and Future Initiatives in Education and Training in Latin America


    Session Chair(s):

    • Juan Carlos Groppa, MD
      Director of the Career of Specialist Phisicians in Pharmac. Med.
      Buenos Aires University, Argentina

    Concurrent Session G: Current and Future Initiatives in Education and Training in Latin America

    Speaker(s):

    • Brazilian Initiatives
      João Massud, MD
      President
      Brazilian Society of Pharmaceutical Medicine (SBMF), Brazil
    • UCSD Initiatives
      Leonel Villa Caballero, MD
      Director Clinical Trials Programs for Latin America
      UC San Diego, United States
    • Mexican Initiatives
      Jose Gerardo Gonzalez, MD
      Universidad Autonoma De Nuevo Leon, Mexico
  • 4:30PM - 5:30PM

    Concurrent Session H: Budget Negotiation and Hidden Costs for Research Sites in the LA Region


    Session Chair(s):

    • No-image Gustavo Kesselring, MD
      Executive Director
      Vis Research, Brazil

    Concurrent Session H: Budget Negotiation and Hidden Costs for Research Sites in the LA Region

    Speaker(s):

    • The Mexican Experience
      Ciro Garcia
      CFO and Business Development Director
      Accelerium Clinical Research, Mexico
    • The Peruvian Experience
      Juan Luis Yrivarren, MD
      Director, Ricardo Palma Clinical Research Center, Peru
    • The Brazilian Experience
      Gustavo Kesselring, MD
      Executive Director
      Vis Research, Brazil
  • 5:30PM - 6:30PM

    Concurrent Session I: Regulatory Site Inspection Experience


    Session Chair(s):

    • Nata Menabde
      Representative to India
      WHO, India

    Concurrent Session I: Regulatory Site Inspection Experience

    Speaker(s):

    • The Mexican Experience
      Jose Gerardo Gonzalez, MD
      Universidad Autonoma De Nuevo Leon, Mexico
    • The Brazilian Experience
      Speaker Invited
      United States
  • 5:30PM - 6:30PM

    Concurrent Session J: TBD


    Session Chair(s):

    • Nata Menabde
      Representative to India
      WHO, India

    Concurrent Session J: TBD

  • 6:30PM - 6:30PM

    Closing Remarks

    Speaker(s):

    • Sergio Guerrero, MD
      Chair, DIA Advisory Council for Latin America
      President/CEO, Accelerium Clinical Research, Mexico

Exhibits  

Booth Rental Fee
USD 3,950.00 per 3m x 3m booth space

Booth Rental Fee Includes

  • Shell scheme structure
  • Company Name Fascia
  • One (1) double outlet
  • One (1) table
  • Two (2) chairs
  • One (1) Full-meeting registration
  • Two (2) booth personnel registrations

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