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Sep 25 2014 8:00AM - Sep 26 2014 6:30PM | CINTERMEX Convention Center
Av. Fundidora No. 501 - Col. Obrera
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
Agenda Details & Event LogisticsEllen Diegel, Event PlannerPhone +1.215.293.5810Fax +1.215.442.6199Ellen.Diegel@diahome.org
Chair, DIA Advisory Council for Latin AmericaPresident/CEO, Accelerium Clinical Research, Mexico
DirectorBiocluster Nuevo Leon, Mexico
Director, Clinical Management, Mexico, Central America and the CarribeanPPD, Mexico
PresidentBrazilian Society of Pharmaceutical Medicine (SBMF), Brazil
Director Infinite Clinical Research, Mexico
Director Clinical ManagementAsociacion Peruana para la Promocion de Investigacion Clinic, Peru
General ManagerTherapeutic Research Institute and Lab., S. A., Guatemala
Vice President and General Manager, Vaccines and Infectious Diseases inVentiv Health Clinical, Argentina
Executive Director, Latin America ViS Research, Brazil
Head Scientific Medical Advisory Board, Prof., Santa Casa MedicalEstern Medical CRO, Brazil
Compliance Director, Latin America and Puerto RicoPfizer, Mexico
Latin American Operations ManagerPRA International, Mexico
Faculty Chair, Hematology & CancerInstituto Tecnologico de Estudios Superiores de Monterrey, Mexico
DirectorBiotech del Norte SA de CV, Mexico
Representante legalIpharma, S.A. de C.V., Mexico
Senior Director, Business Development and Head of Latin American SalesQuintiles, Argentina
President, Ethics Committee, San Jose HospitalInstituto Tecnologico de Estudios Superiores de Monterrey (ITESM), Mexico
Director, Regulatory Affairs & InnovationCANIFARMA, Mexico
Latin America DRA Manager & PolicyRoche, Brazil
Manager, Regulatory and Start-Up, Integrated Site ServicesQuintiles, Chile
Director of the Career of Specialist Phisicians in Pharmac. Med. Buenos Aires University, Argentina
Pharmacology, Basic Medical SciencesInstituto Tecnologico De Estudios Superiores De Monterrey, Mexico
Departamento de Ciencias ClínicasUDEM, Mexico
Secretario Ciencia y Tecnología / CEOFM-UANL / Vitaxentrum, 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.
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.
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.
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.
Concurrent Session A: Regulatory Sites Inspection Experience
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.
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.”
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.
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.
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
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.
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.
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.
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.
Concurrent Session H: Budget Negotiation and Hidden Costs for Research Sites in the LA Region
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.
Concurrent Session J: TBD
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.
Booth Rental FeeUSD 3,950.00 per 3m x 3m booth space
Booth Rental Fee Includes