Sociedad Argentina de Medicina Farmacéutica

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1 Sociedad Argentina de Medicina Farmacéutica Sociedad incorporada a la Asociación Médica Argentina (AMA) Member of International Federation of Associations Pharmaceutical Physicians (IFAPP) BOLETÍN MENSUAL JULIO 2006 Comisión Directiva Dr. Eduardo de la Puente (Presidente) Dra. María Mateo (Secretario) Dr. Daniel Mazzolenis (Tesorero) Dra. Alicia Resquin de Arabehety Dr. Juan Carlos Groppa (Vocales Tit.) Dra Silvia Zieher Dr. Jorge Barello (Vocales Supl.) Organo de Fiscalización: Dr. Flavio Arce Comité de Honor Juan Anderson Héctor J. Arenoso Oscar Caston Atilio Barbeito Eduardo Bernardiner Carlos Bonazzi Jorge Braun Cantilo Andres Descalzo Ramon Fernandez Rodolfo Gechter Elena Iannotti Julio Koch Jorge Soutric Carlos Tessi Juan C. Wiemeyer Luis F. Collia (coordinador 2004) Ex- Presidentes Peter Brandt (1970) Jorge Braun Cantilo (1972) Rodolfo Gechter (1974) Elena Iannotti (1976) Juan Anderson (1978) Héctor J. Arenoso ( 1980,1990) Julio Koch (1982) Atilio Barbeito (1984) Oscar Caston (1986) Carlos Tessi (1988) Eduardo Bernardiner (1992) Andres Descalzo ( 1994) Jorge Soutric (1996) Juan C. Wiemeyer (1998) Luis F. Collia (2000) Dra. Alicia Resquin de Arabehety (2002) PARTICIPAR: DIFERENCIA O INDIFERENCIA? Un nuevo año ha comenzado. Los proyectos que formulamos en el que pasó, ocupan hoy nuestros escritorios y agendas. En estas etapas, uno siente la tentación de formular balances, repasar lo hecho; logros y pendientes. Pero al referirse a una visión de largo plazo, este camino inevitablemente conduce a la reiteración. Parece más prometedor volver a vislumbrar el futuro más próximo de lo que parece- y anticipar los pasos por venir. SAMEFA está encaminada hacia sus objetivos fundamentales, que la ubican como centro académico y científico de la Medicina Farmacéutica en Argentina: Reconocimiento de la Carrera de Especialista (Facultad de Medicina; Universidad de Buenos Aires) Homologación de la carrera con los lineamientos de la IFAPP Publicación de la única revista de la especialidad en nuestro país Postulación de Argentina como sede del ICPM 2008 Esta es la base sólida sobre la cual será posible construir el crecimiento de nuestra Sociedad. El camino recorrido nos ha llevado hasta este presente en el que confrontamos un punto crítico: seguir la inercia actual, con riesgo de entrar en parálisis y finalmente, retroceso o gestar el cambio para crecer. Crecer es sumar. Hechos, voluntades, decisiones, resultados. Esfuerzo. Trabajo. Sin estos componentes, el crecimiento no es posible. La nuestra es una sociedad joven y aún pequeña, pero posee todo el potencial para crecer; sólo necesita del aporte de sus miembros. Desde organizar un curso hasta conseguir un sponsor; de la redacción de un artículo, el dictado de una clase o atrayendo un nuevo socio, todo suma para crecer. La clave del presente de SAMEFA es la PARTICIPACIÓN En unos pocos meses, los plazos estatuidos requieren que la conducción societaria sea renovada. Las formalidades del llamado a Asamblea, la aprobación de la memoria y el balance y el acto eleccionario, se cumplirán ritualmente. No obstante esto, lo esencial es que las personas que integran la Sociedad Argentina de Medicina Farmacéutica, se involucren en el proceso. En el caso contrario, todo lo anterior sería nada mas que eso, un rito. Es tiempo de escuchar nuevas voces, organizar listas de candidatos, debatir. Sumemos ideas, propuestas, equipos de trabajo. Tomemos la iniciativa para liderar el cambio y crecer. Si no nos gana la indiferencia, la participación puede hacer la diferencia

2 NUEVO HORARIO DE ATENCIÓN DE LA SECRETARÍA DE SAMEFA SAMEFA tiene el agrado de informar a sus socios que se modificará el horario de atención de la Secretaría: de los días lunes de 13 a 17 horas a los martes de 13 a 17 horas. Por otra parte, no sufrirá modificaciones el habitual horario de los viernes de 13 a 17 horas. Novedades Por cualquier consulta, por favor comunicarse con la Secretaría al teléfono (011) o por a PRESENCIA ARGENTIN A EN EL 14º CONGRESO DE LA IFAPP A CELEBRARSE EN SEUL Entre los días 3 y 6 de septiembre próximos se celebrará en Seul el 14º Congreso de la IFAPP (en las próximas páginas de este boletín reproducimos un programa reducido). En esta ocasión, queremos destacar la presencia argentina en tan importante evento: los doctores Luis Collia y Daniel Mazzolenis participarán como speakers en dos conferencias y además, el doctor Luis Pliego se sumará como asistente a la repreentación de nuestro país. En el próximo número de este boletín, se presentará un informe de lo acontecido en ese importante Congreso como así también sobre las actividades de la Reunión de la DIA que se celebra en Brasil. Actualidad Internacional de la Industria Farmacéutica: También queremos compartir con nuestros asociados el link para acceder a la información referente al Fourth European Summer School in Clinical Pharmacology and Therapeutics a celebrarse en Varsovia. Estos datos pueden resultar muy interesantes, sobre todo para los profesionales que se desempeñan en empresas de origen SAMEFA europeo. El link es:

3 Untitled Document If you cannot view the page, please click on the link ICPM 2006 Scientific Program Sep. 4 (Mon) Sep. 5 (Tue) Sep. 6 (Wed) Clinical Trials: Experiences in the Emerging Market Clinical Trials: Opportunities and Challenges in Asia Focus on Patient: The Importance of Proactive Pharmacovigilance Ethics in Pharmaceutical Medicine Pharmaceutical Medicine New Initiatives in Pharmaceutical Medicine Training Value of Innovative Medicine Biomarker in Drug Development Cutting-Edge Technology in Drug Development Pharmacogenomics How to Improve Access to Medicine *Clinical Research Project Management *QA & QC in Clinical Trials Drug Safety Management *Document Writing in Clinical Research *Qualification of CR Professional Ø 16 CPD credits by the Faculty of Pharmaceutical Medicine. Ø The asterisks(*) indicates CPE(Continuing Professional Education) Session. Don't Delay, Register Now Register for ICPM 2006 before the Early-Bird Registration deadline (June 30, 2006) SECRETARIAT: c/o CMPMedica Korea 2Fl. BMS Bldg Yeoksam-dong, Gangnam-gu, Seoul , Korea Phone: / Fax: Official web-site: file:///c /Mis%20documentos/jorge/amaifa/SAMEFA/2006/mayo/Untitled%20Document.htm (1 of 2) [07/07/06 07:51:23 p.m.]

4 Untitled Document file:///c /Mis%20documentos/jorge/amaifa/SAMEFA/2006/mayo/Untitled%20Document.htm (2 of 2) [07/07/06 07:51:23 p.m.]

5 3rd Latin American Congress of Clinical Research Topics in Clinical Research and Drug Development With a Training Course on September 25, 2006 entitled: Good Clinical Practices for the Clinical Research Professional* September 25-27, 2006 IEP Hospital Sírio Libanes, São Paulo, BRAZIL PROGRAM GUSTAVO LUIZ F. KESSELRING President, Brazilian Society of Pharmaceutical Medicine, BRAZIL PROGRAM COMMITTEE SONIA DAINESI Manager, Support Center for Clinical Research, Clinicas Hospital, FMUSP, BRAZIL SÉRGIO NISHIOKA Manager, Office of New Drugs and Clinical Trials, ANVISA, BRAZIL EDUARDO MOTTI Clinical Research Manager, Schering AG, BRAZIL LUÍS COLLIA IFAPP President, ARGENTINA SERGIO SLAWKA Treasurer Brazilian Society of Pharmaceutical Medicine, BRAZIL ADOLFO DORENBAUM Chief Financial Officer, IMIC, MEXICO EDUARDO FORLÉO General Manager, Vigiun, BRAZIL DAGOBERTO BRANDÃO Director, PHC Consulting, BRAZIL MARCELO LIMA General Secretary, Brazilian Society of Pharmaceutical Medicine, BRAZIL CHARLES SCHMIDT Director Operations, Latin America PRA International, BRAZIL MANUEL FRESNO General Manager Latin América, MDS Pharma Services, ARGENTINA WELLINGTON BRIQUES General Manager, Dr Reddy s, BRAZIL LAURA LUCCHINI Executive Director, Eurotrials BRAZIL OVERVIEW This congress is composed of an advanced-level, one-day pre-congress course, and a two-day conference with presentations of topics ranging from global to specific details of clinical research. Presentations will include ICH and FDA updates, Latin American regulatory guidelines and ethical issues, infrastructure and components of clinical research, and perspectives for the development of clinical research in Latin America. LEARNING OBJECTIVES Discuss the regulatory principles and procedures in clinical research and interact with the regulatory stakeholders Discuss ways to 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 becoming competitive in the research arena. Describe the Latin America environment related to opportunities of expansion in clinical research TARGET AUDIENCE This congress is directed at research personnel (clinical, laboratory, site members and CRAs), CROs and SMOs, service providers, clinical investigators (active and potential), ethics committees, regulatory agencies, medical education institutions, pharma sponsors, and others involved directly and/or indirectly in clinical research, or who are considering initiating their activities in this professional area. Simultaneous translation will be available in both Portuguese and English * Good Clinical Practices for the Clinical Research Professional Training Course is limited to 60 participants, so register early! CONTACT INFORMATION Tabletop Exhibits: Managing Eventos Phones / Meeting: USA: Julie Ho, Phone / Brazil and other Countries: Managing Eventos Phone / VISIT FOR A % COMPLETE SCHEDULE OF EVENTS! DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: fax:

6 Learning Objectives of Pre-Congress Course: At the conclusion of this course, participants should be able to: Identify the roles and responsibilities of each member of the study team including the clinical investigator, sub-investigator, study staff, IRB, and sponsor Apply the regulations and guidelines for conducting safe and effective clinical trials Describe the various processes for informed consent Recognize successful patient recruitment and retention strategies Manage study compliance during clinical trials Properly categorize and report adverse events Recognize the multiple types of audits and how to prepare for each Note: The Pre-Congress Course is limited to 60 participants. Please register early. PRE-CONGRESS COURSE GOOD CLINICAL PRACTICES FOR THE CLINICAL RESEARCH PROFESSIONAL TRAINING COURSE 8:30-9:00 SESSION 2 THE ROLE AND RESPONSIBILITIES OF THE STUDY STAFF, RESEARCH INSTITUTION, AND RESEARCH OVERVIEW With the goal of helping to ensure well trained clinical investigators and study staff to conduct safe and effective clinical trials, this training course provides the knowledge required to conduct clinical trials, including knowledge about subject safety, regulations, and the practicalities of performing research studies. Although this course was originally designed for a North American audience, the faculty for this offering includes experts from Latin America, and the best practices content remains relevant and valuable for clinical research professionals in Latin America, as well. 9:00-9:45 SESSION 3 THE DRUG DEVELOPMENT PROCESS EXERCISE: WHICH PHASE IS IT? 9:45-10:15 SESSION 4 THE ROLES AND RESPONSIBILITIES OF THE INSTITUTIONAL REVIEW BOARD / INDEPENDENT ETHICS COMMITTEE 7:30-8:00 REGISTRATION MONDAY SEPTEMBER 25 8:00-10:15 PART I: ROLES AND RESPONSIBILITIES Part 1 of the course will outline the drug development process and identify and define the entities and personnel involved in this process. Key topics will include defining the roles and responsibilities of Clinical Investigators, Ethics Committee/IRBs, Institutions, and Sponsors. Material presented will be based upon the regulations from the United States Food and Drug Administration (FDA), International Conference on Harmonization (ICH) Guidelines, as well as industry-accepted best practices. INSTRUCTORS Alicia A. Pouncey Managing Director Aureus Research Consultants, LLC, UNITED STATES Robert R. Skip Hall, Jr. Manager, Clinical Site Monitoring, Bristol-Myers Squibb Company Pharmaceutical Research Institute, Global Development Operations Regional Clinical Operations - BRAZIL DISCUSSANT Patricia Saidon Pharmacology Professor Pharmacology Department University of Buenos Aires, ARGENTINA 8:00-8:30 SESSION 1 THE ROLE AND RESPONSIBILITIES OF THE CLINICAL INVESTIGATOR 10:15-10:30 REFRESHMENT BREAK 10:30-12:15 PART II: REGULATIONS AND GUIDELINES THAT GOVERN CLINICAL INVESTIGATION Part 2 of the course will focus upon identifying and defining the regulations that support good clinical practice (GCP) and the ethical conduct of clinical trials. The historical events leading to these Regulations will also be discussed. Specific attention will be directed to the ethical principles that are the basis of reinforcing human subject protection. The course will also define the elements of informed consent and outline the expectations of Investigators and staff with the informed consent process. 10:30-11:00 SESSION 5 REGULATIONS AND GOOD CLINICAL PRACTICE GUIDELINES 11:00-11:20 SESSION 6 ETHICAL CONDUCT IN CLINICAL RESEARCH 11:20-11:55 SESSION 7 THE INFORMED CONSENT PROCESS EXERCISE: INFORMED CONSENT Statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA. 2

7 11:55-12:15 SESSION 8 HISTORY BEHIND HUMAN SUBJECT PROTECTION 12:15-13:00 LUNCHEON 8:00-9:00 REGISTRATION TUESDAY SEPTEMBER 26 13:00-17:00 PART III: PRACTICES THAT ENSURE EFFECTIVE AND EFFICIENT STUDY CONDUCT Part 3 highlights the preparation, conduct, and completion of a clinical investigation from the perspective of the Investigator and study site. Topics will include how clinical Investigators can secure clinical trials, best-practices for subject recruitment, as well as offer recommendations for expected interaction with study Sponsors. This final part of the course will also define US regulatory requirements, ICH guidelines, and industry best-practices for study conduct, specifically focusing upon proper adverse event reporting and documentation of trial data. The expectations of the Investigator and site during Sponsor audits and FDA inspections will also be presented. 13:00-13:45 SESSION 9 STUDY PREPARATION 13:45-14:00 SESSION 10 STUDY INITIATION 14:00-14:35 SESSION 11 CONDUCTING THE STUDY: VOLUNTEER RECRUITMENT, RETENTION AND COMPLIANCE 9:00-9:30 WELCOME AND OPENING REMARKS Gustavo Luiz F. Kesselring President, Brazilian Society of Pharmaceutical Medicine, BRAZIL Jorge Kalil President, Instituto de Ensino e Pesquisa Sírio Libanês, BRAZIL Gabriel Tannus President, INTERFARMA, BRAZIL 9:30-10:45 AM PLENARY SESSION I PHARMACOVIGILANCE AND RISK MANAGEMENT Sonia Dainesi Manager, Support Center for Clinical Research, Clinicas Hospital, FMUSP, BRAZIL Some recent safety-related issues in the clinical development program of new medicines have lead to important changes in the way Pharmacovigilance is done in the pharma companies as well as in the regulatory agencies. The way of following up adverse events became a very complex and strategic activity for everybody involved with risk and crisis management. The goal of this session will be therefore to learn/discuss how this process is being conducted in one pharmaceutical industry and the interaction with the regulatory agencies. 14:35-15:00 SESSION 12 CONDUCTING THE STUDY: MANAGING MONITOR VISITS 15:00-15:15 REFRESHMENT BREAK RISK MANAGEMENT IN THE PHARMACEUTICAL INDUSTRY Elena Apetri Global Medical Surveillance, Schering AG, GERMANY INTERACTION WITH THE REGULATORY AGENCY Murilo Freitas Pharmacovigilance Manager, ANVISA, BRAZIL 15:15-16:10 SESSION 13 ADVERSE EVENTS AND SAFETY MONITORING 10:45-11:15 REFRESHMENT BREAK 11:15-12:45 PLENARY SESSION II EXERCISE: IS IT EXPECTED? 16:10-16:25 SESSION 14 STUDY CLOSURE 16:25-16:50 SESSION 15 MANAGING A SITE AUDIT 16:50-17:00 FINAL Q AND A 17:00 END OF DAY I CURRENT REGULATORY ENVIRONMENT OF CLINICAL RESEARCH IN LATIN AMERICA Sérgio Nishioka Manager Office of New Drugs and Clinical Trials, ANVISA, BRAZIL Latin America has recently become one of the most active regions for clinical trials in the world. The environment of Latin America has improved over the last years and increasingly operates in accordance with international standards and guidelines. This session will present an up to date to the approval process across the main countries in the region. 3

8 REGULATIONS AND TIMELINES IN ARGENTINA/CHILE Patrícia Saidon Pharmacology Department, University of Buenos Aires, ARGENTINA REGULATIONS AND TIMELINES IN MEXICO TO BE ANNOUNCED Speaker from Mexico REGULATIONS AND TIMELINES IN BRAZIL Eduardo Motti Clinical Research Manager, Schering AG, BRAZIL 12:45-13:45 LUNCHEON 13:45-15:15 CONCURRENT SESSIONS 13:45-15:15 CONCURRENT SESSION A EDUCATION IN CLINICAL RESEARCH Luís Collia IFAPP President, ARGENTINA In this session, information about the importance of education in all issues about clinical research: the role of the University in this kind of training and, the importance and needs of postgraduate education in clinical research will be presented. Finally, what is the role and opportunity of Pharmaceutical industry in this matter will be discussed. THE ROLE OF UNIVERSITY IN CLINICAL RESEARCH TRAINING Jorge Kalil Full Professor Imunology, School of Medicine, University of São Paulo, BRAZIL IS THERE ROOM FOR POST-GRADUATION COURSES? Artur Beltrame Ribeiro Full Professor of Nephrology, Federal University of São Paulo, BRAZIL 13:45-15:15 CONCURRENT SESSION B ONCOLOGY TRIALS Sergio Slawka Treasurer Brazilian Society of Pharmaceutical Medicine, BRAZIL Fulfillment of both critical targets in cancer research, patients enrollment and quality of data, might be enhanced through a network of skilled institutions committed to these same goals. Experience in the construction and management of an impressive network in this field, covering all major Brazilian geographical regions and sites will be presented.special features of clinical protocols in cancer patients such as endpoints social perception of the disease, familial impact for patients, greater incidence of adverse events and major awareness about maintenance of treatment after concluding the protocol will be discussed. BRAZILIAN NETWORK ON CANCER RESEARCH Frederico Costa Oncologist Sírio Libanês Hospital, BRAZIL CLINICAL RESEARCH EDUCATION AS AN OPPORTUNITY TO PHARMA INDUSTRY IMAGE Maurício Silva de Lima Medical Director Lilly, BRAZIL MAIN DIFFERENCES BETWEEN ONCOLOGY AND OTHER THERAPEUTIC AREAS Carlos Gil Ferreira Oncologist, National Institute of Cancer (INCA), BRAZIL SURVIVAL X TIME TO PROGRESSION, CHEMOTHERAPY X BIOLOGIC DRUGS Alberto Wainstein BIOCANCER Director, BRAZIL 15:15-15:45 REFRESHMENT BREAK 15:45-17:15 CONCURRENT SESSIONS 15:45-17:15 CONCURRENT SESSION A FINANCIAL AND LEGAL ISSUES IN CLINICAL RESEARCH Adolfo Dorenbaum Chief Financial Officer, IMIC, MEXICO This session will discuss important issues regarding financial and legal aspects related to clinical trials. Keypoints will be pointed out that occur during a clinical trial and that can generate civil liability. Financial protocols and their interrelations with ethical research committee, investigators and sponsors will be presented. Guidelines on this matter will be presented as well. Civil liability and clinical trials more and more have their relationship increased. So, it is important to discuss actions and procedures that minimize this link. Risk management on this matter will be the keynote of this session. 15:45-17:15 CONCURRENT SESSION B VACCINE DEVELOPMENT Eduardo Forléo General Manager, Vigiun BRAZIL Vaccine studies represent a smaller, but not negligible piece of the total amount of R&D that has been ongoing in Latin America during the last decade. Although deemed as easier to conduct, these studies have specific characteristics, are not simple to implement, and may require the enrollment of thousands of subjects. In addition, as vaccines are closely linked to public health policies their development in Latin America has to take into account local epidemiologic and pharmaco-economic issues. During this session, three experts with different backgrounds will share their expertise in this exciting field. 4

9 CONFLICTING BUDGETARY ISSUES IN CLINICAL RESEARCH Nadine Clausell Clinical Research Unit, Federal University Rio Grande do Sul, BRAZIL VACCINE RESEARCH IN LATIN AMERICA Ralf Clemens Head Worldwide Development at Novartis Vaccines,, BRAZIL LEGAL RESPONSIBILITIES FOR INVESTIGATOR/INSTITUTION/SPONSOR IN CLINICAL RESEARCH Dagoberto Brandão Director, PHC Consulting, BRAZIL CHALLENGES IN LARGE-SCALE EFFICACY TRIALS Rosanna Lagos Investigator and Coordinator of the Center for Vaccine Development in Chile, CHILE ETHICAL ISSUES IN FINANCIAL AND LEGAL ASPECTS OF CLINICAL RESEARCH José Luis Viramontes Director, Clinical Research, Merck Sharp Dohme, MEXICO IMPORTANCE OF CLINICAL TRIALS FOR HEALTH PUBLIC POLICIES Reinaldo de Menezes Martins Head Advisor of Clinical Research, Bio-Manguinhos, Fiocruz, BRAZIL 17:15 END OF DAY II WEDNESDAY SEPTEMBER 27 9:00-10:30 PLENARY SESSION I CURRENT CHALLENGES IN CLINICAL RESEARCH Gustavo Kesselring President SBMF, BRAZIL Human subject protection is a basic requirement of clinical research. With the rapid advancement in bio medical research, the issues faced by ethics committees and clinical professionals in addressing and overseeing clinical research are becoming more complex. The pharmaceutical industry is facing an unprecedented challenge in restoring public confidence in the contribution of pharmaceuticals to healthcare and the value of new drug innovation generated by an ethical and quality process of clinical research. In this session panelists from academia and regulatory authorities will present their insights that could impact patient welfare. CHALLENGES IN BIOETHICS IN CLINICAL TRIALS Reidar Lie Department of Clinical Bioethics, NIH National Institutes of Health, USA CHALLENGES IN QUALITY ASSURANCE AND FRAUD PREVENTION IN CLINICAL TRIALS TO BE ANNOUNCED Speaker from USA CHALLENGES IN PUBLIC IMAGE OF CLINICAL RESEARCH Gary L. Chadwick, PharmD Executive Director, Office for Human Subject Protection University of Rochester, USA 11:00-12:30 PLENARY SESSION II STRATEGIC ASPECTS OF CLINICAL RESEARCH IN LATIN AMERICA Marcelo Lima General Secretary SBMF, BRAZIL The volume of clinical drug development conducted in Latin America is growing rapidly. Major pharmaceutical companies and CROs are expanding staff and increasing business activity in the region. The favorable factors for this exponential growth can be listed as large patient populations, sometimes naïve patients, qualified health professionals, more defined regulatory environment and rising levels of ICH-GCP compliance. However, the Latin America participation on the global clinical research is far behind its full potential. There are yet country-specific technical, regulatory and political barriers to be overcome. The purpose of this session is to discuss and possibly provide alternatives to foster the participation of the major Latin American pharmaceutical markets on the global drug development. WHERE IS LATIN AMERICA TODAY AND WHERE MAY IT GET TO IN CLINICAL RESEARCH? Gary L. Chadwick, PharmD Executive Director, Office for Human Subject Protection University of Rochester, USA BARRIERS AND SOLUTIONS FOR THE EXPANSION OF CLINICAL RESEARCH IN LATIN AMERICA Enrique Isola Chief Scientific Officer, Region Latin America Novartis, USA 12:30-13:30 LUNCHEON 10:30-11:00 REFRESHMENT BREAK DRUG INFORMATION ASSOCIATION Horsham, PA, USA Basel, Switzerland Tokyo, Japan Tel: Fax: Tel: Fax: Tel: Fax:

10 13:30-15:00 CONCURRENT SESSIONS 13:30-15:00 CONCURRENT SESSION A ETHICS COMMITTEES IN LATIN AMERICA Sonia Maria Oliveira de Barros Ethics Committee Coordinator, Hospital Albert Einstein, BRAZIL The recent increase in clinical research in emerging countries imposes new ethical dilemmas for local ethics committees. Lack of training in this area may cause noncompliance with regulations and guidelines and can delay the time to start clinical trials. Brazilian experience in training members to face these new dilemmas will be presented. This session will also discuss challenges of human subject protection in the developing world and the international experiences in this field with Independent Review Boards (IRBs). CHALLENGES IN ECS TRAINING José O. Medina Pestano Head of Ethics Committee of São Paulo Hospital, UNIFESP, BRAZIL VULNERABILITY OF TRIAL PATIENTS IN THE DEVELOPING WORLD Elma Zoboli Ethics Committee, University of São Paulo, BRAZIL 13:30-15:00 CONCURRENT SESSION B CRO-SPONSOR RELATIONSHIP Charles Schmidt Director Operations Latin America, PRA International, BRAZIL Outsourcing clinical services demands full comprehension of all aspects related to the pharma industry and contract research organizations. Both opportunities and challenges in this relationship will be discussed. Understanding both sides of the issue is basic for the success of the projects and to establish strategic plans for contingencies and best solutions. This session will present the experience of important representatives from pharma and the CRO industry in dealing with this partnership. SHARING RESPONSIBILITIES BETWEEN INDUSTRY AND CROS Sebastian Pacios Vice President, PRA International, USA CLINICAL RESEARCH TEAMS: PROS/CONS OF INTERNAL STAFF Jaderson Lima Medical Director, Sanofi-Aventis, BRAZIL CLINICAL RESEARCH TEAMS: PROS/CONS OF OUTSOURCING Andy Strayer Senior Vice President, PPD Americas/Asia, USA INTERNATIONAL EXPERIENCE OF INDEPENDENT REVIEW BOARDS Gustavo Kaltwasser Former Medical Director, Western IRB, CHILE 15:00-15:30 REFRESHMENT BREAK 15:30-17:00 CONCURRENT SESSIONS 15:30-17:00 CONCURRENT SESSION A SELECTION OF RESEARCH SITES Manuel Fresno General Manager Latin América, MDS Pharma Services, ARGENTINA Selection of the right research sites is key for the success of any clinical trial. Research sites usually determine a substantial part of the cost, time and quality of a clinical trial. TIMING X QUALITY X COSTS João Fittipaldi Medical Director, Pfizer, BRAZIL WHY CHOOSE AN ACADEMIC CENTER? Décio Mion Associate Professor, School of Medicine University of São Paulo, BRAZIL WHY CHOOSE A NON-ACADEMIC CENTER? Cristiano Zerbini Director, Clinical Research Center, Rheumatology Department, Heliópolis Hospital, BRAZIL 15:30-17:00 CONCURRENT SESSION B PRIORITIES IN CLINICAL RESEARCH Wellington Briques General Manager, Dr Reddy s, BRAZIL During this session, important points that could make or break any clinical study will be discussed, including improvement of regulatory approval rates, approaches to enhanced accrual and retention, and the directions the national pharma companies are taking with their R&D departments to play a more important role on the discovery landscape. ROLE OF CLINICAL RESEARCH IN R&D FOR NATIONAL COMPANIES Marcio Falci Medical Department, BIOLAB, BRAZIL SPEEDING UP THE REGULATORY PRE-STUDY PHASE Sonia Dainesi Manager, Support Center for Clinical Research, Clinicas Hospital, FMUSP, BRAZIL IMPROVING THE ACCRUAL AND RETENTION INTO CLINICAL TRIALS Laura Lucchini Executive Director, Eurotrials, BRAZIL 17:00 WORKSHOP ADJOURNED 6

11 HOTEL RESERVATION FORM Family Name First Name Company Address City State Zip/Postal Code Country Telephone Fax ( address required for receipt of reservation confirmation.) PAYMENT / RESERVATION MUST BE GUARANTEED WITH A CREDIT CARD. Credit Card Type: MasterCard Visa Diners Club American Express Other Card Number Expiration Date Name of Card Holder Signature ROOM INFORMATION Please Circle: Standard / Double Single/queen bed Double/twin beds Arrival date Arrival time Departure date Departure time Check-in time: 15:00 o clock, check-out time: 12:00 o clock. Fax this form to the fax number listed below for your preferred hotel. DO NOT FAX HOTEL RESERVATION FORM TO DIA / MANAGING EVENTOS. TRAVEL AND HOTEL The most convenient airport is Guarulhos International Airport (GRU), which is approximately 20 miles from the hotels. Attendees should make airline reservations as early as possible to ensure availability. The hotels below are optional (estimated rates); for other information or reservations, contact the hotel offices directly. Blue Tree Towers Paulista (***) p: (55 11) / f: (55 11) US$ single / US$ double Crowne Plaza (****) p: (55 11) / f: (55 11) US$ single/double Della Volpe (****) p: (55 11) / f: (55 11) US$ single/double Marriott/Renaissance (*****) p: (55 11) / f: (55 11) US$ single / US$ double (taxes and breakfast included) (Special rates for Congress attendees please include the following ID in the reservation: "DIA/SBMF Congress"). Please note the location of the meeting is within walking or cab distance, more details to follow. Participants with Disabilities: DIA meeting facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the meeting if requested at least 15 days prior to meeting. Contact the DIA office to indicate your needs. 7

12 CARRERA DE ESPECIALISTA EN MEDICINA FARMACÉUTICA Avanzan las gestiones para poner en marcha la Carrera de Especialista en Medicina Farmacéutica. Hace un par de semanas fueron respondidas nuevas requisitorias de la UBA que, se estima, serán las últimas. El expediente se encuentra en estos momentos en la Universidad donde se analizarán las respuestas presentadas por los responsables de la Carrera. A pesar de las dificultades que se vienen presentando con este anhelado proyecto, estamos seguros de que finalmente lograremos el objetivo que nos hemos planteado. Cursos SAMEFA

13 NUEVAS SUBCOMISIONES Relaciones Internacionales: Dr. Collia Comunicación y Marketing: Dr. J. Barello, Dr. Matín Salmún Actividades Académicas : Dra. A. Arabehety, Dr. Arenoso y col. Asuntos Legales y Regulatorios: Dras. A. Arabehety y Silvia Zieher Nos despedimos hasta el próximo número Sociedad Argentina de Medicina Farmacéutica Mejores Fármacos para una Medicina Mejor Nuestra Nueva Dirección: Marcelo T. de Alvear Capital Federal- Tel Días y Horarios de Atención: Lunes y Viernes de 13 a 17 hs. Nuestro Correo Electrónico:

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