Presentación de PowerPoint

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
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.)
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)
2006
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
Novedades
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.
Por cualquier consulta, por favor comunicarse con la Secretaría al teléfono (011) 49662800 o por e-mail a [email protected]
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 europeo.
SAMEFA
El link es: www.eacpt.vrsac.com
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ICPM 2006 Scientific Program
Sep. 4 (Mon)
Sep. 5 (Tue)
Sep. 6 (Wed)
Clinical Trials: Experiences in the
Emerging Market
Pharmaceutical Medicine
Cutting-Edge Technology in Drug
Development
Clinical Trials: Opportunities and
Challenges in Asia
New Initiatives in Pharmaceutical
Medicine Training
Pharmacogenomics
Focus on Patient:
The Importance of Proactive
Pharmacovigilance
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: [email protected] Official web-site: http://www.icpm2006.org/
file:///C|/Mis%20documentos/jorge/amaifa/SAMEFA/2006/mayo/Untitled%20Document.htm (1 of 2) [07/07/06 07:51:23 p.m.]
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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 CHAIRPERSON
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
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.
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
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: [email protected]
Meeting: USA: Julie Ho, Phone +1-215-442-6179/email [email protected]
Brazil and other Countries: Managing Eventos – Phone 55 11 5587-5232 / 5594-4669
email: [email protected]
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: [email protected]
Learning Objectives of Pre-Congress Course:
At the conclusion of this course, participants should be able to:
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
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
Note: The Pre-Congress Course is limited to 60 participants. Please register early.
PRE-CONGRESS COURSE
8:30-9:00
OVERVIEW
9:00-9:45
and study staff to conduct safe and effective clinical trials, this training course provides the knowledge required to conduct clinical trials,
MONDAY • SEPTEMBER 25
AND
DRUG DEVELOPMENT
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
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.
PART I: ROLES
SESSION 3 – THE
EXERCISE: WHICH PHASE IS IT?
including knowledge about subject safety, regulations, and the practicalities of performing research studies. Although this course was
8:00-10:15
AND
PROCESS
With the goal of helping to ensure well trained clinical investigators
REGISTRATION
ROLE
RESPONSIBILITIES OF THE STUDY STAFF,
RESEARCH INSTITUTION, AND RESEARCH
GOOD CLINICAL PRACTICES FOR THE CLINICAL
RESEARCH PROFESSIONAL TRAINING COURSE
7:30-8:00
SESSION 2 – THE
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.
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.
INSTRUCTORS
Alicia A. Pouncey
Managing Director
Aureus Research Consultants, LLC, UNITED STATES
10:30-11:00
REGULATIONS AND GOOD
PRACTICE GUIDELINES
SESSION 5 –
CLINICAL
Robert R. “Skip” Hall, Jr.
Manager, Clinical Site Monitoring, Bristol-Myers Squibb Company
Pharmaceutical Research Institute, Global Development Operations
Regional Clinical Operations - BRAZIL
11:00-11:20
SESSION 6 – ETHICAL
CONDUCT
IN
CLINICAL
RESEARCH
DISCUSSANT
11:20-11:55
Patricia Saidon
SESSION 7 – THE INFORMED
CONSENT
PROCESS
Pharmacology Professor
Pharmacology Department
University of Buenos Aires, ARGENTINA
EXERCISE: INFORMED CONSENT
8:00-8:30
SESSION 1 – THE
RESPONSIBILITIES
INVESTIGATOR
ROLE
AND
OF THE
CLINICAL
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
11:55-12:15
SESSION 8 –
TUESDAY • SEPTEMBER 26
HISTORY BEHIND HUMAN
SUBJECT PROTECTION
12:15-13:00
LUNCHEON
13:00-17:00
PART III: PRACTICES THAT ENSURE
EFFECTIVE AND EFFICIENT STUDY
CONDUCT
8:00-9:00
REGISTRATION
9:00-9:30
WELCOME AND OPENING REMARKS
Gustavo Luiz F. Kesselring
President, Brazilian Society of Pharmaceutical
Medicine, BRAZIL
Jorge Kalil
Part 3 highlights the preparation, conduct, and completion of a
President, Instituto de Ensino e Pesquisa Sírio
Libanês, BRAZIL
clinical investigation from the perspective of the Investigator and
study site. Topics will include how clinical Investigators can secure
Gabriel Tannus
President, INTERFARMA, BRAZIL
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 con-
9:30-10:45
duct, specifically focusing upon proper adverse event reporting and
documentation of trial data. The expectations of the Investigator
PHARMACOVIGILANCE
SESSION 9 – STUDY
13:45-14:00
SESSION 10 – STUDY INITIATION
14:00-14:35
SESSION 11 – CONDUCTING THE STUDY:
VOLUNTEER RECRUITMENT, RETENTION
AND COMPLIANCE
RISK MANAGEMENT
Sonia Dainesi
Manager, Support Center for Clinical Research, Clinicas Hospital,
FMUSP, BRAZIL
PREPARATION
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.
RISK MANAGEMENT
14:35-15:00
AND
CHAIRPERSON
and site during Sponsor audits and FDA inspections will also be
presented.
13:00-13:45
PLENARY SESSION I
AM
IN THE
PHARMACEUTICAL INDUSTRY
Elena Apetri
SESSION 12 – CONDUCTING THE STUDY:
MANAGING MONITOR VISITS
Global Medical Surveillance, Schering AG, GERMANY
INTERACTION
WITH THE
REGULATORY AGENCY
Murilo Freitas
15:00-15:15
REFRESHMENT BREAK
15:15-16:10
SESSION 13 –
Pharmacovigilance Manager, ANVISA, BRAZIL
ADVERSE EVENTS
AND
10:45-11:15
REFRESHMENT BREAK
11:15-12:45
PLENARY SESSION II
SAFETY MONITORING
CURRENT REGULATORY ENVIRONMENT
RESEARCH IN LATIN AMERICA
EXERCISE: IS IT EXPECTED?
OF
CLINICAL
CHAIRPERSON
16:10-16:25
SESSION 14 – STUDY
CLOSURE
Sérgio Nishioka
Manager Office of New Drugs and Clinical Trials, ANVISA,
BRAZIL
MANAGING
16:25-16:50
SESSION 15 –
16:50-17:00
FINAL Q AND A
17:00
END OF DAY I
A
SITE AUDIT
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
REGULATIONS
AND
TIMELINES
IN
ARGENTINA/CHILE
REGULATIONS
Patrícia Saidon
Pharmacology Department, University of Buenos Aires,
ARGENTINA
REGULATIONS
AND
TIMELINES
IN
12:45-13:45
Clinical Research Manager, Schering AG, BRAZIL
13:45-15:15
CONCURRENT SESSIONS
13:45-15:15
CONCURRENT SESSION A
IN
TIMELINES
IN
MEXICO
BRAZIL
Eduardo Motti
EDUCATION
AND
TO BE ANNOUNCED
Speaker from Mexico
13:45-15:15
CLINICAL RESEARCH
LUNCHEON
CONCURRENT SESSION B
ONCOLOGY TRIALS
CHAIRPERSON
CHAIRPERSON
Luís Collia
Sergio Slawka
IFAPP President, ARGENTINA
Treasurer Brazilian Society of Pharmaceutical Medicine, BRAZIL
In this session, information about the importance of education in all
issues about clinical research: the role of the University in this kind of
Fulfillment of both critical targets in cancer research, patients enrollment and quality of data, might be enhanced through a network of
training and, the importance and needs of postgraduate education in
clinical research will be presented. Finally, what is the role and oppor-
skilled institutions committed to these same goals. Experience in the
construction and management of an impressive network in this
tunity of Pharmaceutical industry in this matter will be discussed.
field, covering all major Brazilian geographical regions and sites will
be presented.Special features of clinical protocols in cancer patients
THE ROLE
OF
UNIVERSITY
IN
CLINICAL RESEARCH TRAINING
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.
Jorge Kalil
Full Professor Imunology, School of Medicine,
University of São Paulo, BRAZIL
IS THERE ROOM
FOR
POST-GRADUATION COURSES?
Artur Beltrame Ribeiro
BRAZILIAN NETWORK
Full Professor of Nephrology, Federal University of São Paulo,
BRAZIL
Frederico Costa
Oncologist Sírio Libanês Hospital, BRAZIL
CLINICAL RESEARCH EDUCATION
INDUSTRY IMAGE
MAIN DIFFERENCES BETWEEN ONCOLOGY
THERAPEUTIC AREAS
AS AN
OPPORTUNITY
TO
PHARMA
ON
CANCER RESEARCH
AND
OTHER
Carlos Gil Ferreira
Maurício Silva de Lima
Oncologist, National Institute of Cancer (INCA), BRAZIL
Medical Director Lilly, 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
15:45-17:15
CONCURRENT SESSION B
VACCINE DEVELOPMENT
CLINICAL RESEARCH
CHAIRPERSON
CHAIRPERSON
Adolfo Dorenbaum
Eduardo Forléo
Chief Financial Officer, IMIC, MEXICO
General Manager, Vigiun BRAZIL
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
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.
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.
4
CONFLICTING BUDGETARY ISSUES IN CLINICAL RESEARCH
VACCINE RESEARCH
Nadine Clausell
Ralf Clemens
Clinical Research Unit, Federal University Rio Grande do Sul,
BRAZIL
Head Worldwide Development at Novartis
Vaccines, , BRAZIL
LEGAL RESPONSIBILITIES FOR
INVESTIGATOR/INSTITUTION/SPONSOR
CHALLENGES
IN
FINANCIAL
LEGAL ASPECTS
AND
OF
IMPORTANCE
CLINICAL
OF
CLINICAL TRIALS
HEALTH PUBLIC POLICIES
Head Advisor of Clinical Research, Bio-Manguinhos,
Fiocruz, BRAZIL
Director, Clinical Research, Merck Sharp Dohme, MEXICO
END OF DAY II
11:00-12:30
WEDNESDAY • SEPTEMBER 27
PLENARY SESSION II
STRATEGIC ASPECTS
AMERICA
9:00-10:30
FOR
Reinaldo de Menezes Martins
José Luis Viramontes
17:15
LARGE-SCALE EFFICACY TRIALS
Investigator and Coordinator of the Center for Vaccine
Development in Chile, CHILE
Director, PHC Consulting, BRAZIL
IN
LATIN AMERICA
Rosanna Lagos
CLINICAL RESEARCH
Dagoberto Brandão
ETHICAL ISSUES
RESEARCH
IN
IN
IN
CLINICAL RESEARCH
IN
LATIN
CHAIRPERSON
PLENARY SESSION I
CURRENT CHALLENGES
OF
Marcelo Lima
CLINICAL RESEARCH
General Secretary SBMF, BRAZIL
CHAIRPERSON
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
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
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.
CLINICAL TRIALS
WHERE IS LATIN AMERICA TODAY
CLINICAL RESEARCH?
Reidar Lie
Department of Clinical Bioethics, NIH National Institutes of
Health, USA
CHALLENGES IN QUALITY ASSURANCE
IN CLINICAL TRIALS
AND
PUBLIC IMAGE
FRAUD PREVENTION
BARRIERS AND SOLUTIONS FOR
RESEARCH IN LATIN AMERICA
GET TO
THE
EXPANSION
OF
CLINICAL
Enrique Isola
OF
Chief Scientific Officer, Region Latin America
Novartis, USA
CLINICAL RESEARCH
Gary L. Chadwick, PharmD
Executive Director, Office for Human Subject Protection
University of Rochester, USA
10:30-11:00
IT
Executive Director, Office for Human Subject Protection
University of Rochester, USA
Speaker from USA
IN
WHERE MAY
Gary L. Chadwick, PharmD
TO BE ANNOUNCED
CHALLENGES
AND
IN
12:30-13:30
LUNCHEON
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
email: [email protected]
Tel: +41-61-225-51-51 • Fax: +41-61-225-51-52
email: [email protected]
Tel: +81-3-5511-1131 • Fax: +81-3-5511-0100
email: [email protected]
5
13:30-15:00
CONCURRENT SESSIONS
13:30-15:00
CONCURRENT SESSION A
ETHICS COMMITTEES
IN
CONCURRENT SESSION B
13:30-15:00
CRO-SPONSOR RELATIONSHIP
LATIN AMERICA
CHAIRPERSON
CHAIRPERSON
Sonia Maria Oliveira de Barros
Charles Schmidt
Ethics Committee Coordinator, Hospital Albert Einstein,
BRAZIL
Director Operations Latin America, PRA International, BRAZIL
Outsourcing clinical services demands full comprehension of all
The recent increase in clinical research in emerging countries
aspects related to the pharma industry and contract research organizations. Both opportunities and challenges in this relationship will
imposes new ethical dilemmas for local ethics committees. Lack of
training in this area may cause noncompliance with regulations and
be discussed. Understanding both sides of the issue is basic for the
success of the projects and to establish strategic plans for contin-
guidelines and can delay the time to start clinical trials. Brazilian
experience in training members to face these new dilemmas will be
presented.
gencies and best solutions. This session will present the experience
of important representatives from pharma and the CRO industry in
This session will also discuss challenges of human subject protec-
dealing with this partnership.
tion in the developing world and the international experiences in
this field with Independent Review Boards (IRBs).
SHARING RESPONSIBILITIES BETWEEN INDUSTRY
AND
CROS
Sebastian Pacios
CHALLENGES
IN
Vice President, PRA International, USA
ECS TRAINING
José O. Medina Pestano
CLINICAL RESEARCH TEAMS: PROS/CONS
Head of Ethics Committee of São Paulo Hospital, UNIFESP,
BRAZIL
OF INTERNAL
STAFF
Jaderson Lima
Medical Director, Sanofi-Aventis, BRAZIL
VULNERABILITY
OF
TRIAL PATIENTS
IN THE
DEVELOPING WORLD
Elma Zoboli
CLINICAL RESEARCH TEAMS: PROS/CONS
Ethics Committee, University of São Paulo, BRAZIL
Andy Strayer
OF
OUTSOURCING
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
CONCURRENT SESSION B
15:30-17:00
RESEARCH SITES
PRIORITIES
CHAIRPERSON
IN
CLINICAL RESEARCH
CHAIRPERSON
Manuel Fresno
Wellington Briques
General Manager Latin América,
MDS Pharma Services, ARGENTINA
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.
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
ROLE OF CLINICAL RESEARCH
COMPANIES
Medical Director, Pfizer, BRAZIL
IN
R&D
FOR
NATIONAL
Marcio Falci
WHY CHOOSE
AN
ACADEMIC CENTER?
Medical Department, BIOLAB, BRAZIL
Décio Mion
SPEEDING UP
Associate Professor, School of Medicine
University of São Paulo, BRAZIL
WHY CHOOSE
A
THE
Manager, Support Center for Clinical Research, Clinicas
Hospital, FMUSP, BRAZIL
NON-ACADEMIC CENTER?
Cristiano Zerbini
IMPROVING
Director, Clinical Research Center, Rheumatology
Department, Heliópolis Hospital, BRAZIL
Laura Lucchini
17:00
REGULATORY PRE-STUDY PHASE
Sonia Dainesi
THE
ACCRUAL
AND
RETENTION
Executive Director, Eurotrials, BRAZIL
WORKSHOP ADJOURNED
6
INTO
CLINICAL TRIALS
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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.
Cursos
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
NUEVAS SUBCOMISIONES
•
Relaciones Internacionales: Dr. Collia
•
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•
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
Mejores Fármacos
Fármacos para
para una
una Medicina
Medicina Mejor
Mejor
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