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8Th Latin American Congress on Clinical Research Latin America 8th Latin American Congress on Clinical Research Latin America Role in Worldwide Clinical Research AprilPre-congress 19-21, 2010 courses: Tutorials: October April 19, 18,2011 2010 MarriottCongress: Bethesda October North 20-21, Hotel &2011 Conference Center, Bethesda, MD, USA Panamericano Hotel & Resort, Buenos Aires, Argentina This three-day congress will include two pre-congress courses and a CONGRESS CHAIRPERSON two-day conference focusing on both the global and regional aspects Juan Carlos Groppa, MD Past President, SAMEFA (Argentine Society of of clinical research. Pharmaceutical Medicine) Medical Affairs Manager. Laboratorios Bágo S.A., Argentina FEATURED TOPICS SCIENTIFIC COMMITTEE CHAIRPERSON • Cell-Based Therapies: The New Drug Class Hugo Cohen Sabban, MD President, SAMEFA (Argentine Society of • Latin America Regulatory Affairs Update Pharmaceutical Medicine) • First Time in Man & Early Phase Trials CEO, CRO BIOSOLUTION, Argentina • The Contribution of Latin America to Data Quality on Marketing SCIENTIFIC COMMITTEE Applications Sebastián Batagelj, MD Medical Advisor, Laboratorios Bagó, Argentina • Clinical Safety and Pharmacovigilance Daniel Ciriano, MD • Ethical Issues: A Permanent Dilemma Medical Director - Roche Argentina Andrea Costantini, MD • Endpoints, Surrogates and The Rationale on Study Design Medical Advisor, Phoenix Laboratories, Argentina Luis Collia, MD • Streamlining Logistics in the Region Medical Director, Laboratorios Craveri, Argentina • Sponsoring of Clinical Research by Nontraditional Players Wanda Dobrzanski, MD Medical Director, Medical & Scientific Affairs, Respiratory and • Biosimilars and the road ahead Infectious Diseases, i3 Global, Argentina Rosana Felice, MD Medical Director, Argentina & Southern Cone, GlaxoSmithKline, PRECONGRESS COURSES Argentina October 19th Gustavo Fischbein, MD Medical Director, Osmotica Pharmaceutical, Argentina # 1 Risk Project Management Pablo Hammerschmidt, MD # 2 Clinical Quality Assurance: The Basics Regional Director, Clinical Operations, ICON Clinical Research, Argentina Gabriela Kivelevitch, MD WHO SHOULD ATTEND Medical Advisor, Laboratorios Phoenix, Argentina Sandra Mercurio, MD Professionals involved directly and/or indirectly in clinical research, or who Medical Director & Lead Nominated Signatory, AstraZeneca , are considering initiating their activities in this professional area, including: Argentina Luis Pliego, MD • Research professionals (clinical, • Clinical investigators Regional Medical & Regulatory Affairs Manager, Janssen-Cilag, Argentina • laboratory, site members, and (active and potential) Luis Ramirez, MD Regional Head Clinical Operations for Latin America, CRAs) • Ethics committees Boehringer-Ingelheim, Argentina • CROs and SMOs • Regulatory agencies Rosa Scuteri, MD Medical Advisor, Laboratorio Raffo , Argentina • Service providers • Medical education institutions Daniel Vazquez, MD • Pharmaceutical sponsors Senior Director and Latin America Head, Global Regulatory Affairs, Quintiles Argentina S.A., Argentina Marcelo Vianna de Lima Medical Director, Latin America , Medical Diagnostics, Simultaneous Translation will be available in Portuguese, English, GE Healthcare, Brazil and Spanish Silvia Zieher, MD Executive Director, Latin America Operations, INC Research, Argentina Worldwide Headquarters Co-sponsored by All registrations will be processed by Samara & Enrique (Meeting Planners) Contact Information for Registration and Tabletop Opportunities Drug Information Association, Inc. Roxana Samara, Exhibits Department 800 Enterprise Road, Suite 200 +54 9 11 5664 0160 / +54 11 4774 7531 Horsham, PA 19044, USA Email address: [email protected] Registration Link: www.samara-enrique.com.ar/dialatam2011 Regional Offices DIA Program Contact Information Basel, Switzerland Tokyo, Japan Constance Burnett, Program Developer +1 215.293.5800 (tel) | email:[email protected] Mumbai, India Beijing, China 2 DAY 1 | WEDNESDAY, OCTOBER 19TH 08:30-10:00 PLENARY SESSION Conference: Adult Mesenchymal Stem Cells are the New 08:00-08.45 REGISTRATIONS Medicine for Diseases SEssION CHAIRPERSON 09:00–06.30 PRE-CONGRESS TUTORIALS María Jimena Fernández Bartolomé Tutorial 1: Risk Project Management Monitora Estudios Clinicos, Roche, Argentina COURSE DIRECTOR SPEAKER Mr. Marty Hynes III Arnold Caplan Six Sigma Champion, Senior Director Product R&D, Lilly Research Director, Skeletal Research Center, Professor of Biology and Laboratories, Ely Lilly and Company General Medicine Sciences, Case Western Reserve University, Cleveland Ohio, USA Tutorial 2: Clinical Quality Assurance, the Basics 10:00–10:30 REFRESHMENT BREAK COURSE DIRECTORS Ezequiel Klimovsky 10:30-12:30 PLENARY SESSION Associate Director, QUID -Quality in Drugs and Devices- LATAM Consulting SRL, Argentina Round Table: Medical Devices – Clinical Trials Margarita Eiletz SEssION CHAIRPERSON Managing Director, Ethics & Excellence SRL, Argentina Marcelo Vianna de Lima Medical Director, Latin America - Medical Diagnostics, GE DAY 2 | THURSDAY, OCTOBER 20TH Healthcare, Brazil SEssION CO-CHAIRPERSON 07:00-08.00 REGISTRATIONS Hugo Cohen Sabban President, SAMEFA (Argentine Society of Pharmaceutical Medicine) 08:00-08:30 OPENING CEO, CRO BIOSOLUTION, Argentina Welcome and Introduction to DIA 2011 Local Requirements to Running Studies with Devices Marta Kaufman SEssION CHAIRPERSONS ANMAT (Administración Nacional de Medicamentos, Alimentos Juan Carlos Groppa (SAMEFA) y Tecnología Médica), Argentina Argentine Society of Pharmaceutical Medicine Experiences from FDA Inspections on Clinical Trials with Devices in the Medical Affairs. Laboratorios Bágo S.A., Argentina Latin American Region Yves Julliet (DIA) Matthew J. Tarosky DIA President, USA Acting Director, Division of Biosresearch Monitoring Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA Captain, U.S. Public Health Service I Have a Device, and Now? Hugo Kuprinsky Specialist in Obstetrics, CEMIC, Argentina 12:30–02:00 LUNCHEON 02:00-04:00 CONCURRENT SESSIONS Round Table: Biosimilars in Latin America Round Table: The contribution of Latin America Data SEssION CHAIRPERSON to Marketing Applications: a Focus on Quality Joao Masssud SEssION CHAIRPERSON Trials Consulting, BRASIL Silvia Zieher SEssION CO-CHAIRPERSON Executive Director, Latin America Operations, INC Research, Daniel Mazzolenis Argentina General Manager, Kendle , Argentina Ethical and GCP Standards in Latin America: a General Overview Studies with Biologicals in Latam of the Research Ethics Committees and Regulatory Framework Julio Camps Anna Paula Más Regional Director, Latin America, Amgen Development Associate Director, Global Regulatory Development, Latin Operations, USA America, Global Regulatory Affairs, Brasil Studies with Biosimilars in LatAm An Overview of FDA Inspections Experience in Latin America. Speaker to be confirmed FDA Interactions with Local Regulatory Agencies Paul Seligman B&B Development Dilemmas for Latin American Companies Director, FDA Latin America Office Roberto Diez Latin America Regional Office, Costa Rica Clinical Research Manager, Bio Sidus S.A., ARGENTINA EMA Inspections Experience in Latin America and Impact of the Reflection Paper 2010 Fergus Sweeney, EMA (via teleconference) Head of Sector Compliance and Inspections EMA (European Medicines Agency), United Kingdom 04:00–04:30 REFRESHMENT BREAK 3 04:30-06:30 CONCURRENT SESSIONS Round Table: Issues in Logistics within the Region Round Table: Understanding the Rationale behind SEssION CHAIRPERSON the Design of Clinical Research: What Endpoints and Cecilia Dantuono Surrogates Intend to Demonstrate Site Manager, Bristol Myers Squibb, Argentina SEssION CHAIRPERSON SEssION CO-CHAIRPERSON Gustavo Fischbein Daniel Vazquez Medical Director, Osmotica Pharmaceutical Argentina Senior Director and Latin America Head, Global Regulatory SEssION CO-CHAIRPERSON Affairs, Quintiles Argentina S.A, Argentina Marlene Llópiz Avilés Local Requirements CEO - CRO Mexicana, S.C. CEO - CRO Mexicana, S.C. Mexico Marina Ordoñez Objectives in Cardiovascular Research Clinical Site Manager, Bristol Myers Squibb, Perú Daniel R. Nul Topic to be Confirmed Medical Director, Clínica Constituyentes, Argentina Antonela Mangiaterra Objectives in Oncology Research Associate Manager, Clinical Logistics, PAREXEL International Speaker to be confirmed Clinical Logistics Services | Latin America, Argentina Objectives in CNS Research Topic to be Confirmed Gonzalo Gómez Arévalo Flavio Echemendigaray Director, Phvlatam, Argentina Warehouse Manager, Genzyme, Argentina DAY 3 | FRIDAY, OCTOBER 21ST 10:00–10:30 REFRESHMENT BREAK 07:00-08.00 REGISTRATIONS 10:30-12:30 PLENARY SESSION 08:00–08:30 IFAPP CONFERENCE Round Table: Latin American Regulatory Affairs Update SEssION CHAIRPERSON SEssION CHAIRPERSON Luis Collia Speaker to be confirmed Medical Director, Laboratorios Craveri, Argentina SEssION CO-CHAIRPERSON Daniel Vazquez SPEAKER Norbert Clemens Senior Director and Latin America Head, Global Regulatory Affairs, Head Clinical Development, CRS Clinical Research Services Quintiles Argentina S.A., Argentina Mannheim GmbH, Germany Update on Current Clinical Research Regulations Status in Different Latin American Countries 08:30-10:00 PLENARY SESSION Flavia Regina Souza Sobral Specialist in Regulation and Sanitary Surveillance, Anvisa Conference: Early Phase Trials National Agency of Sanitary Surveillance, Brasil SEssION CHAIRPERSON Representatives from Argentina, Chile, Mexico and Perú Leylen Colmegna CEO, LAT Research, Argentina
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