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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 

Simultaneous 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.

To view the agenda in Spanish click here

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
      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

    Keynote

    Speaker(s):

    • TransCelerate Initiatives: Goals and Implications on the Latin American Industry
      Rehbar H. Tayyabkhan
      Executive Director, GDO Business Operations and RCO Latin America
      Bristol-Myers Squibb Company, United States
  • 9:00AM - 10:30AM

    Plenary 1: Economic Impact of Regulations in Regional Competitiveness


    Session Chair(s):

    • No-image Wanda Dobrzanski Nisiewicz M.D., 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

    Round table discussion on how current regional regulations are impacting the Latin American industry’s performance in the global market. Topics to be discussed include the perception of volatility and unpredictability caused by local and regional regulations. Representatives from industry, ethics committees, a regulatory offi cial, patients, and CROs will provide the audience with their perspective on how current regulatory frameworks aff ect the region’s sectoral growth and development.

    Speaker(s):

    • Panelist
      Rafael André Laurino
      Hub Unit Manager, Regional Clinical Operations Brazil
      Bristol-Myers Squibb, Brazil, Brazil
    • 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
    • Concierto de Vida A.C. Asociacion de Esclerosis Multiple
      Jose Constante
      President
      Concierto de Vida a.c. Asociacion de Esclerosis Multiple, Mexico
  • 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

    Session to provide an overview on alliances and partnerships between regulatory bodies and private and educational institutions to foster capacity building 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

    High level discussion on the challenges and opportunities for Ethics Committees in Latin America as they try to obtain a local or external validation of their standard operations procedures. This session will also provide an analysis on the current measures needed to be in compliance with those procedures.

    Speaker(s):

    • Bioethics
      Sarah H. Kiskaddon, JD, MA
      Director, Global Business Development and Public Affairs
      Assn for the Accreditation of Human Research Protection Programs ((AAHRP)), United States
    • The Mexican Perspective
      Carlos Hinojosa, MD
      Deputy Director, Clinical Research
      Instituto Mexicano de Nustricion, Mexico
    • The WHO Perspective - Virtual
      Carla Saenz, PhD
      Bioethics Regional Advisor, Dept. of Knowledge, Management, Bioethics & Research
      Pan American Health Organization, 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

    The systematic collection, proper preservation and cellular and molecular characterization of biospecimens plays an increasingly important role in the understanding of clinical trial outcomes. This session describes the relevance of Biobanks in clinical research. Understanding how data obtained from biospecimens fosters the development of competitive clinical research.

    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
      Jacobo Martinez, MD
      Scientific Director
      Biobanco CSISP, Spain
  • 4:00PM - 5:00PM

    Concurrent Session A: Regulatory Sites Inspection Experience


    Session Chair(s):

    • Rivelino Flores, MSc
      Director, Regulatory Affairs & Innovation
      CANIFARMA, Mexico

    Concurrent Session A: Regulatory Sites Inspection Experience

    Speaker(s):

    • The Mexican Experience
      Jose Gerardo Gonzalez, MD
      Professor, Endocrinology & Internal Medicine
      Universidad Autonoma De Nuevo Leon, Mexico
    • The Peruvian Experience
      Jorge De Los Rios, MD
      Jefe del Servicio de Neumologia
      Hospital Maria Auxiliadora, Peru
  • 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

    This session will discuss our proposed tool for the ethical monitoring of the investigator-research subject relationship in clinical research. This includes its elaboration, a discussion of the problem we are trying to approach, and the results we get after its utilization in diverse clinical research sites.

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


    Session Chair(s):

    • Mauro Martinelli
      Associate Director, Emerging Markets Specialist, Clinical Development
      Quintiles, United States

    Clinical Outsourcing to Latin America is a critical aspect of regional clinical development and growth, while it still remains unexplored for many global pharma, mid-size pharma, as well for Biotech companies. Ask people in the US or Western Europe about any given emerging market and you might hear one of two things – “It’s a great place to do business” or “That market is so scary, I couldn’t possibly work there.”

    Speaker(s):

    • Panelist
      Pablo Garate, MD
      Medical Operations LATAM
      UCB Pharma, Mexico
    • Panelist
      Carolina Carrasco
      Director, Clinical Operations
      Quintiles, 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

    Drug efficacy and adverse drug reactions are usually dose-dependent and determine the clinical outcome of the administration of a particular drug. Personalized Medicine focuses on matching type and dosage according to individual genetic variation. This session will discuss the application of pharmacogenetics for volunteer selection on new drugs and bioequivalence clinical trials. In the case of bioequivalence studies, volunteer selection based on a specifi c metabolism type (fast, normal or slow) could provide more accurate trial results and clinical outcomes. The application of pharmacogenetics in Clinical Trials will be discussed.

    Speaker(s):

    • Mexican Population, Clinical Significance for Anticoagulants
      Vanessa Gonzalez, MD
      Associate Researcher
      INMEGEN, Mexico
    • Application of Pharmacogenetics in Personal Medicine
      Xavier Soberon, MD
      Director
      INMEGEN, Mexico
    • Pharmacogenetics of Pharmacokinetics Highly Variable Drugs
      Rafael Baltazar Reyes Lyon, MD
      Professor
      Universidad de Monterrey, 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

    This session is devoted to informing and educating the general public and patient advocates on the rights and responsibilities of the patients participating in Clinical Trials. NGO representatives, the Human Rights Ombudsman offi ce representative and COFEPRIS will discuss the importance of patients participating in Clinical Trials regardless of whether or not patients are assisted in a public health facility.

    Speaker(s):

    • The Civil Society Perspective
      Eduardo Soto Pineda, MD
      Profesor Emerito del Doctorado de Administracion, Facultad de Admin. y Economia
      Universidad de Santiago de Chile, Chile
    • The Human Rights Perspective
      Victor Manuel Martinez Bulle-Goyri, MD
      Professor
      Universidad Nacional Autonoma de Mexico, Mexico
    • The Government Perspective
      Emma Verastegui Aviles, MD, PhD
      Servico de Cuidados Paliativos
      Instituto Nacional de Cancerología , Mexico
  • 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

    Session devoted to analyzing supply chain issues in Latin America, focusing on outlining the advantages of entering into emerging markets for clinical trials to save costs.
    • Identifying the different regulatory requirements for entering into new clinical hotspots to ensure shipments are fully prepared with all documentation
    • Establishing a strategy that takes into account the various time required for different countries at each stage of the clinical supply chain
    • Developing a flexible supply chain that can adapt to unprecedented obstacles
    • Forecasting any potential issues with QPs at each stage of the supply chain

    Speaker(s):

    • Imports of Clinical Trial Supplies - Procedures, Difficulties & Impact on Cold Chain
      Filiberto Garcia Rodriguez
      Customs Operations and Legal Affairs for International Trading, Mexico
      Mexico
    • Storage and Distribution of Investigational Drugs & Clinical Supplies, Temperature Compliance & Solutions
      Lizett Tapia Plata
      World Courier De Mexico, Mexico
    • How the Supply Chain will be Affected by the Updated GDP Guidelines & the Increase of Biological Drugs & Cell Therapies
      Reynaldo Roman
      Senior Manager Regulatory Compliance
      Marken LLP, United States
  • 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

    Biosimilar products are emerging as an option of treatment. LA pharmaceutical companies are trying to introduce their products to the global market, however the clinical research process has not been clearly defi ned to guarantee safety. This session will provide an overview of experiences of regulatory guidelines in clinical evaluation of biosimilar products and how troubles have been solved. The aim of this session is to present and contrast the global experiences in clinical evaluation of biosimilar products and how LA clinical research can support pharmaceutical companies to evaluate their biosimilar products.

    Speaker(s):

    • Development & Regulation of Biosimilars: Mexican Experience
      Areli Ceron Sanchez
      Clinical Trials Coordinator
      COFEPRIS, Mexico
    • Development & Regulation of Biosimilars: Brazilian Experience
      Laura Gomes Castanheira
      Head of Regulatory Affairs
      Hemobrás- Empresa Brasileira de Hemoderivados e Biotecnologia, Brazil
  • 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

    Risk-based Monitoring is becoming an essential educational need for both the industry and CROs as well as research sites. This session will provide a view on how Risk-based Monitoring is being approached in Latin America and how this element will become more frequent moving forward.

    Speaker(s):

    • The Journey of Deploying Risk-based Monitoring in a Strategic Partnership: Status and Future Perspectives
      Claudia Ferolla
      Covance Mexico Services, S. de RL de CV, Mexico
    • 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

    Gene therapy uses genes themselves and mechanisms to control their action to offer new therapeutic approaches for inherited, infectious, and neoplastic diseases, representing a new hope for curing current untreatable diseases. This session will describe the current status of gene therapy and the progress of bringing its promise into the clinical trials scenario and will provide an understanding of how a gene therapy clinical trial is performed.

    Speaker(s):

    • Clinical Trials in Gene Therapy
      Roberto Tofani Sant'Anna, MD
      Investigator
      Cardiology Institute do Rio Grande do Sul, Brazil
    • First Gene Therapy Clinical Trials in Latin America
      Augusto Rojas Martinez
      Professor, School of Medicina
      Universidad Autonoma de Nuevo Leon, Mexico
  • 3:30PM - 4:30PM

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


    Session Chair(s):

    • No-image João Massud, MD
      President
      Brazilian Society of Pharmaceutical Medicine (SBMF), Brazil
    • Fabiola Encinas, MD
      Country Manager
      MedPace, Mexico

    Speaker(s):

    • Sponsor
      Angel Mario Coll Munoz, MD, PhD
      Senior Country Clinical Operations Manager
      Abbvie Pharmaceitocals, S.A. de C.V., Mexico
    • Latin American CRO
      Federico Lerner, MD
      Senior Director, Latin America
      PRA INTL., Argentina
  • 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, Latin America
      ViS Research, Brazil

    Session devoted to analyzing and discussing multi-regional clinical research sites and will focus on the connecting of research sites to sponsors through new technologies tools.

    Speaker(s):

    • Panelist
      Otis Johnson
      Vice President, Clinical Research Services
      Inventiv Clinical Trial Recruitment Solutions, 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
  • 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, Latin America
      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, Latin America
      ViS Research, Brazil
  • 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

    This session aims to help create awareness among the general public of the paramount importance of improving the quality of the multiple training and learning initiatives in the region. This round table features the most distinguished training and courses to be developed in Latin America, including a comparison on the most traditional methods versus the most modern ones.

    Speaker(s):

    • Brazilian Initiatives
      João Massud, MD
      President
      Brazilian Society of Pharmaceutical Medicine (SBMF), Brazil
    • UCSD Initiatives
      Leonel Villa Caballero
      UC San Diego, United States
    • Mexican Initiatives
      Jose Gerardo Gonzalez, MD
      Professor, Endocrinology & Internal Medicine
      Universidad Autonoma De Nuevo Leon, Mexico
  • 5:30PM - 6:30PM

    Concurrent Session J: TBD


    Session Chair(s):

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

    Concurrent Session J: TBD

    Speaker(s):

    • Regulatory Development of Ethics Committees for Research in Mexico
      David Alejandro Lopez Vibaldo
      Anthropologist, Chief of Research, Ethics Committee Department
      National Bioethics Commission – CONBIOETICA, Mexico
    • Civil Responsibility Insurance for Clinical Trials in Mexico
      Fernando Perez Galaz
      Clinical Risks Administrator
      GMX, Mexico
    • Global Perspective
      Vicente Alciturri Gandarillas
      CEO
      Semicrol S.L., Spain
  • 5:30PM - 6:30PM

    Concurrent Session I: 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

    The pharmaceutical industry faces challenges related to communicating and managing medical information for a variety of health care providers or to patients/general public regarding the risks and benefi ts of its products. This communication can be provided by creating an innovative medical information contact center, which will help the Medical Science Liaisons fulfi ll their functions. This session will review the necessary elements to build a world-class medical information center, with a focus on technology, compliance issues, and staffing models.

    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
    • Gabriela Zepeda Orozco
      Gerente de Asesores Científicos e Información Médica
      Novartis, Mexico
  • 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

Useful Links

  • Grupo Mexicano de Seguros
  • Grupo Sicamsa
  • Marken
  • PPD
  • Quintiles
  • Semicrol
  • World Courier de México
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