Sociedad Argentina de Medicina Farmacéutica BOLETÍN ... - samefa

Sociedad Argentina
de Medicina Farmacéutica
Sociedad incorporada a la Asociación Médica Argentina (AMA)
Member of International Federation of Associations Pharmaceutical Physicians (IFAPP)
Comisión Directiva
2004-2006
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.)
BOLETÍN MENSUAL JULIO 2006
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

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) 4966-
2800 o por e-mail a samefa@gmail.com
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: www.eacpt.vrsac.com

Untitled Document
ICPM 2006 Scientific Program
If you cannot view the page, please click on the link
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
Pharmaceutical Medicine
New Initiatives in Pharmaceutical
Medicine Training
Value of Innovative Medicine
Ethics in Pharmaceutical Medicine Biomarker in Drug Development
How to Improve Access to Medicine Drug Safety Management
*Clinical Research Project
Management
*Document Writing in Clinical
Research
*QA & QC in Clinical Trials *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. 829-1 Yeoksam-dong, Gangnam-gu, Seoul 135-936, Korea
Phone: +82-2-2007-5440 / Fax: +82-2-561-4707
e-mail: secretariat@icpm2006.org Official web-site: http://www.icpm2006.org/
Cutting-Edge Technology in Drug
Development
Pharmacogenomics
file:///C|/Mis%20documentos/jorge/amaifa/SAMEFA/2006/mayo/Untitled%20Document.htm (1 of 2) [07/07/06 07:51:23 p.m.]

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.]

3rd Latin American Congress of Clinical Research
GUSTAVO LUIZ F. KESSELRING
President, Brazilian Society of Pharmaceutical
Medicine, BRAZIL
Topics in Clinical Research
and Drug Development
With a Training Course on September 25, 2006 entitled:
Good Clinical Practices for the Clinical Research Professional*
PROGRAM CHAIRPERSON
PROGRAM COMMITTEE
September 25-27, 2006 | IEP Hospital Sírio Libanes, São Paulo, BRAZIL
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 55 11 5587-5232 / 5594-4669
email: managingeventos@uol.com.br
Meeting: USA: Julie Ho, Phone +1-215-442-6179/email Julie.Ho@diahome.org
Brazil and other Countries: Managing Eventos – Phone 55 11 5587-5232 / 5594-4669
email: managingeventos@uol.com.br
VISIT WWW.DIAHOME.ORG FOR A % COMPLETE SCHEDULE OF EVENTS!
DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: dia@diahome.org

Learning Objectives of Pre-Congress Course:
At the conclusion of this course, participants should be able to:
PRE-CONGRESS COURSE
GOOD CLINICAL PRACTICES FOR THE CLINICAL
RESEARCH PROFESSIONAL TRAINING COURSE
OVERVIEW
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
With the goal of helping to ensure well trained clinical investigators
and study staff to conduct safe and effective clinical trials, this train-
ing course provides the knowledge required to conduct clinical trials,
including knowledge about subject safety, regulations, and the prac-
ticalities 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 prac-
tices content remains relevant and valuable for clinical research pro-
fessionals in Latin America, as well.
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
2
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.
8:30-9:00 SESSION 2 – THE ROLE AND
RESPONSIBILITIES OF THE STUDY STAFF,
RESEARCH INSTITUTION, AND RESEARCH
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
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 reg-
ulations 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.

11:55-12:15 SESSION 8 – HISTORY BEHIND HUMAN
SUBJECT PROTECTION
12:15-13:00 LUNCHEON
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 require-
ments, ICH guidelines, and industry best-practices for study con-
duct, 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
14:35-15:00 SESSION 12 – CONDUCTING THE STUDY:
MANAGING MONITOR VISITS
15:00-15:15 REFRESHMENT BREAK
15:15-16:10 SESSION 13 – ADVERSE EVENTS AND
EXERCISE: IS IT EXPECTED?
SAFETY MONITORING
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
3
8:00-9:00 REGISTRATION
TUESDAY • SEPTEMBER 26
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
CHAIRPERSON
Sonia Dainesi
Manager, Support Center for Clinical Research, Clinicas Hospital,
FMUSP, BRAZIL
Some recent safety-related issues in the clinical development pro-
gram 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 con-
ducted in one pharmaceutical industry and the interaction with the
regulatory agencies.
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
10:45-11:15 REFRESHMENT BREAK
11:15-12:45 PLENARY SESSION II
CURRENT REGULATORY ENVIRONMENT OF CLINICAL
RESEARCH IN LATIN AMERICA
CHAIRPERSON
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 accor-
dance with international standards and guidelines. This session will
present an up to date to the approval process across the main
countries in the region.

REGULATIONS AND TIMELINES IN ARGENTINA/CHILE
Patrícia Saidon
Pharmacology Department, University of Buenos Aires,
ARGENTINA
REGULATIONS AND TIMELINES IN BRAZIL
Eduardo Motti
Clinical Research Manager, Schering AG, BRAZIL
13:45-15:15 CONCURRENT SESSIONS
13:45-15:15 CONCURRENT SESSION A
EDUCATION IN CLINICAL RESEARCH
CHAIRPERSON
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 oppor-
tunity 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
CLINICAL RESEARCH EDUCATION AS AN OPPORTUNITY TO PHARMA
INDUSTRY IMAGE
Maurício Silva de Lima
Medical Director Lilly, 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
CHAIRPERSON
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 dur-
ing a clinical trial and that can generate civil liability. Financial protocols and
their interrelations with ethical research committee, investigators and spon-
sors 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.
4
REGULATIONS AND TIMELINES IN MEXICO
TO BE ANNOUNCED
Speaker from Mexico
12:45-13:45 LUNCHEON
13:45-15:15 CONCURRENT SESSION B
ONCOLOGY TRIALS
CHAIRPERSON
Sergio Slawka
Treasurer Brazilian Society of Pharmaceutical Medicine, BRAZIL
Fulfillment of both critical targets in cancer research, patients enroll-
ment 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 aware-
ness about maintenance of treatment after concluding the protocol
will be discussed.
BRAZILIAN NETWORK ON CANCER RESEARCH
Frederico Costa
Oncologist Sírio Libanês Hospital, 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
15:45-17:15 CONCURRENT SESSION B
VACCINE DEVELOPMENT
CHAIRPERSON
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 stud-
ies 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.

CONFLICTING BUDGETARY ISSUES IN CLINICAL RESEARCH
Nadine Clausell
Clinical Research Unit, Federal University Rio Grande do Sul,
BRAZIL
LEGAL RESPONSIBILITIES FOR
INVESTIGATOR/INSTITUTION/SPONSOR IN CLINICAL RESEARCH
Dagoberto Brandão
Director, PHC Consulting, BRAZIL
ETHICAL ISSUES IN FINANCIAL AND LEGAL ASPECTS OF CLINICAL
RESEARCH
José Luis Viramontes
Director, Clinical Research, Merck Sharp Dohme, MEXICO
17:15 END OF DAY II
WEDNESDAY • SEPTEMBER 27
9:00-10:30 PLENARY SESSION I
CURRENT CHALLENGES IN CLINICAL RESEARCH
CHAIRPERSON
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 innova-
tion 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
10:30-11:00 REFRESHMENT BREAK
DRUG INFORMATION ASSOCIATION http://www.diahome.org
Horsham, PA, USA Basel, Switzerland Tokyo, Japan
Tel: +1-215-442-6100 • Fax: +1-215-442-6199 Tel: +41-61-225-51-51 • Fax: +41-61-225-51-52 Tel: +81-3-5511-1131 • Fax: +81-3-5511-0100
email: dia@diahome.org email: diaeurope@diaeurope.org email: diajapan@diajapan.org
5
VACCINE RESEARCH IN LATIN AMERICA
Ralf Clemens
Head Worldwide Development at Novartis
Vaccines, , BRAZIL
CHALLENGES IN LARGE-SCALE EFFICACY TRIALS
Rosanna Lagos
Investigator and Coordinator of the Center for Vaccine
Development in Chile, CHILE
IMPORTANCE OF CLINICAL TRIALS FOR HEALTH PUBLIC POLICIES
Reinaldo de Menezes Martins
Head Advisor of Clinical Research, Bio-Manguinhos,
Fiocruz, BRAZIL
11:00-12:30 PLENARY SESSION II
STRATEGIC ASPECTS OF CLINICAL RESEARCH IN LATIN
AMERICA
CHAIRPERSON
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 participa-
tion 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

13:30-15:00 CONCURRENT SESSIONS
13:30-15:00 CONCURRENT SESSION A
ETHICS COMMITTEES IN LATIN AMERICA
CHAIRPERSON
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 protec-
tion 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
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
CHAIRPERSON
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
17:00 WORKSHOP ADJOURNED
6
13:30-15:00 CONCURRENT SESSION B
CRO-SPONSOR RELATIONSHIP
CHAIRPERSON
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 organ-
izations. 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 contin-
gencies 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
15:30-17:00 CONCURRENT SESSION B
PRIORITIES IN CLINICAL RESEARCH
CHAIRPERSON
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

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Address _______________________________________________________________________________________________________
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Telephone _____________________________________________________________________________________________________
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email ______________________________________________________________________________________________
(email address required for receipt of reservation confirmation.)
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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.
Blue Tree Towers Paulista (***)
p: (55 11) 3147-7000 / f: (55 11) 3147-7001 – www.bluetree.com.br
US$ 103.00 single / US$ 120.00 double
Crowne Plaza (****)
p: (55 11) 4501-8000 / f: (55 11) 3253-7199 – www.ihgplc.com
US$ 180.00 single/double
HOTEL RESERVATION FORM
ROOM INFORMATION
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.
Della Volpe (****)
p: (55 11) 3549-6464 / f: (55 11) 3288-8710 – www.nh-hotels.com
US$ 224.00 single/double
Marriott/Renaissance (*****)
p: (55 11) 3069-2233 / f: (55 11) 3064-2700 – www.marriottbrasil.com/saobr
US$ 172.00 single / US$ 190.00 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

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.
SAMEFA
Cursos

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 2270 - Capital Federal- Tel. 4966-2800
Días y Horarios de Atención: Lunes y Viernes de 13 a 17 hs.
Nuestro Correo Electrónico: samefa@gmail.com