7th Latin American Congress of
Clinical Research:
Harmonization and the Future of
Drug Development in Latin America
Pre-congress Courses: November 10, 2010
April
19-21,
2010 11-12,
Tutorials:
Congress:
November
2010 April 18, 2010
Maksoud Plaza Hotel, São Paulo, Brazil
PROGRAM CHAIRPERSON
João Massud Filho
Universidade Federal de São Paulo
CEO/Executive Director, Newcotrials, Brazil
PROGRAM CO-CHAIRPERSON
Juan Carlos Groppa
SAMEFA (Argentina Society of Pharmaceutical Medicine); Medical
Regulations Coordinator, Laboratorios Bágo S.A., Argentina
SCIENTIFIC COMMITTEE
This three-day congress will include two pre-congress courses and a
two-day conference focusing on both the global and regional aspects
of clinical research.
FEATURED TOPICS
• ICH and FDA Updates
• Latin American Regulatory Guidelines and Ethical Issues
Charles Schmidt
• Infrastructure and Components of Clinical Research
General Manager Latin America, Medpace, Brazil
• Perspectives on the Development and Comparison of Emerging Markets
of Clinical Research with Latin America
Marcelo Vaz
Senior Clinical Research Physician, Icon Clinical Research, Brazil
Gustavo Luiz F. Kesselring
• Perspectives on Professional Development in Clinical Research
Director, Clinical Trials Operation, Hospital Alemao Oswaldo
Cruz, Brazil
• Examples of Translational Research — Basics to Public Health Interest
Jorge Kalil
PRECONGRESS COURSES
Full Professor, Immunology, School of Medicine, University of
São Paulo, Brazil
Marcelo Vianna de Lima
President, Brazilian Society of Pharmaceutical Medicine (SBMF);
Medical Director, Latin America - Medical Diagnostics,
GE Healthcare, Brazil
Paula Strassmann
November 10
#1 Hands-on in Latin America: Regulations for Clinical Trials
#2 Clinical Project Management: Essential Tools to Optimize
Clinical Trial Operations
President, PGS Medical Statistics, Brazil
Daniel Mazzolenis
Associate Director, Global Clinical Development, Kendle
International Inc, Argentina
Silvia Zieher
Senior Director, Head of Clinical Operations Latin America,
INC Research, Argentina
WHO SHOULD ATTEND
Professionals involved directly and/or indirectly in clinical research, or who
are considering initiating their activities in this professional area, including:
• Research professionals (clinical,
laboratory, site members, and CRAs)
• Ethics committees
Oscar Podestá
General Manager, Latin America, Chiltern International
Inc., Argentina
• CROs and SMOs
• Medical education institutions
Sergio Guerrero
• Service providers
• Pharmaceutical sponsors
Director, OCA Hospital/Monterrey International Research Center,
Mexico; DIA Board of Directors
• Clinical investigators (active and
potential)
Marlene Llopiz-Aviles
• Regulatory agencies
Regional Director for Latin America, Venn Life Sciences, Mexico
Eduardo Gotuzzo
Gotuzzo Asociados Sac, Peru
All registrations will be processed by Managing Eventos
Contact Information for Registration and Tabletop Opportunities
Valéria Gomes, Managing Eventos, Congress Planning and Organization
7th Latin America Congress of Clinical Research - SBMF/DIA
Phone: 55 11 5587-5232 | Phone/fax: 55 11 3208-2786
email address: [email protected]
Registration Link: http://sbmf.org.br
DIA Program Contact Information
Wendy Moyer, Program Manager
Phone: +1.215.293.5810 | email: [email protected]
Simultaneous Translation will be available in Portuguese, English,
and Spanish.
Co-sponsored by
Worldwide Headquarters
Drug Information Association, Inc.
800 Enterprise Road, Suite 200
Horsham, PA 19044, USA
Regional Offices
Basel, Switzerland Tokyo, Japan Mumbai, India Beijing, China
2
LEARNING OBJECTIVES:
At the conclusion of this course, participants should be able to:
• Explain the regulatory principles and procedures of clinical research and interact with the regulatory stakeholders in the region
• 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 become competitive in the research arena
• Compare Latin American opportunities with other emerging markets in clinical research
• Explore professional clinical research opportunities
• Discuss the divide between basic research and public health innovation in the clinical research arena
DAY 1 | WEDNESDAY, NOVEMBER 10
7:30 - 8:15
TUTORIAL COURSE REGISTRATION
8:15 - 8:40
INTRODUCTION
Silvia Zieher
Senior Director, Head of Clinical Operations Latin America
INC Research, Argentina
8:40 - 18:00
10:30 - 11:45
Hands-on the Argentina Regulations
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TUTORIAL #1
Regulatory Framework: main regulations & features
Timelines and steps: regulatory strategy
Preparing your submission to ECs. EC review processes
Preparing the protocol initial submission to ANMAT. ANMAT protocol
review process
Amendments and additional sites submissions
Label requirements & Importation of supplies
Progress reports to ANMAT
Q&A
Mónica Viard
BMS
Hands-on the Regulations for Clinical Trials in
Latin America
Carolina Diaz Rato
i3
INSTRUCTOR
Silvia Zieher
Senior Director, Head of Clinical Operations Latin America
INC Research, Argentina
11:45 - 13:00
Hands-on the Mexican Regulation
Tutorial Learning Objectives
• Identify the trends and major challenges in the regulatory environment
and current regulations in Latin America (LA)
• Outline the steps needed to obtain regulatory approvals in each of the
major LA countries
• Prepare the regulatory submission package for Ethics Committees and
Regulatory Authorities in each major LA country
• Discuss how to optimize the regulatory process through a defined
regulatory strategy implemented
• Describe the importation process in major LA countries – how it is done and
what is needed
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8:40-10:00
Hands-on the Brazilian Regulations
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Regulatory Framework: main regulations & features
Timelines and steps: regulatory strategy
Preparing your submission to ECs. EC review process (CEP and CONEP).
Dossier content for protocol submission to ANVISA
Importation process in Brazil
Q&A
Anna Paula Mass
PPD
Tania Nacamoto Takada
Pfizer
10:00 - 10:30
BREAK
Regulatory Framework: main regulations & features
Timelines and steps: regulatory strategy
Preparing your submission to ECs. EC review process
Preparing your protocol submission to COFEPRIS.
Amendments and additional sites submissions
Label requirements & Importation of supplies
Q&A
Teresa Gonzalez Pichardo
sanofi-aventis
Hortencia Melgar
Kendle
13:00 - 14:00
LUNCH
14:00 - 15:15
Hands-on the Regulations in Central America, Colombia & Venezuela
• Summary of main regulations & features
• Q&A
Yohana Granados
LATAM Clinical Trials
3
15:15 - 15:50
Hands-on the Chilean Regulations
• Regulatory Framework: main regulations & features
• Timelines and steps: regulatory strategy
• Preparing your submission to ECs. EC review process
• Preparing your submission to ISP. The ISP review process
• Applying to the “Authorization for Use” at GICONA
• Q&A
Mafalda Gimenez
Quintiles
15:50 - 16:30
Hands-on the Peruvian Regulations
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Regulatory Framework: main regulations & features
Timelines and steps: regulatory strategy
Dossier content for submitting to ECs
Dossier content for submitting to INS. The INS review process
Applying to the importation license in Peru: DIGEMID review process
Q&A
Melissa Brosset
Gotuzzo & Associados
16:30 - 16:45
BREAK
16:45 - 17:30
Informed Consenting Process and Documentation:
A Regulatory and Ethical Perspective (Review of Main Countries)
Maria Mateo
INC Research
17: 30 - 18:00
Ethics Committees Composition and Functioning in LA:
Assessing Compliance
Patricia Saidón
PAHO red PARF
8:00 - 18:00
TUTORIAL #2
Clinical Project Management:
Essential Tools to Optimize Clinical Trial Operations
INSTRUCTOR
Cris Howard, MBA, MEd, PMP
Senior Clinical Project Manager
Product Development-Gaithersburg MD
Emergent BioSolutions
8:00 – 8:30
WELCOME AND INTRODUCTIONS
• Introductions
• Course Objectives
8:30 – 8:55
MODULE 1: Why Clinical Project Management?
• Successes in biopharmaceutical product development
• Challenges facing biopharmaceutical product development
• Opportunities within biopharmaceutical product development
8:55 – 9:15
MODULE 2: What is Clinical Project Management?
• Key definitions
• Characteristics of a successful project manager
• SELF-ASSESSMENT: Characteristics of a successful project manager
9:15 – 9:45
MODULE 3: Defining the Clinical Project Scope
• Strategic vision and objectives
• Scope statements
9:45 – 10:00
REFRESHMENT BREAK
10:00 – 12:30
MODULE 4: Planning the Work
• SMALL GROUP EXERCISE:
„ sub-projects
„ work packages
„ deliverables
• SMALL GROUP EXERCISE:
• SMALL GROUP EXERCISE:
• SMALL GROUP EXERCISE:
• SMALL GROUP EXERCISE:
managing float
12:30 – 1:30
1:30 – 1:45
Breaking down the work:
Work package durations
Creating a network map
Producing the schedule
Critical path compression and
LUNCHEON
REVIEW
1:45 – 2:30
MODULE 5: Clinical Project Risk Management
• Risk assessment
• Risk control
• SMALL GROUP EXERCISE: Clinical project risk identification and planning
2:30 – 3:30
MODULE 6: Preparing a Clinical Trial Budget
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Tips & tricks in budget forecasting
Laying the budget groundwork
Fixed fees
Variable fees
Pass-through costs
Clinical trial line items
Stating your assumptions
4
3:30 – 3:45
REFRESHMENT BREAK
3:45 – 4:15
MODULE 7: Clinical Trial Execution, Monitoring and Control
• The project management triangle
• Investigator score card
• Clinical trial score card
9:30-11:00
PLENARY SESSION 1
Working for Harmonization on Regulations for
Clinical Trials in Latin America
SESSION CHAIRPERSON
Sergio Guerrero
Director, OCA Hospital/Monterrey International Research Center,
Mexico; DIA Board of Directors
Session Co-chairperson
4:15 – 4:45
MODULE 8: Closing the Project
• Project Termination
• Team closure
• Lessons learned
4:45 – 5:00
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Daniel Mazzolenis
Associate Director, Global Clinical Development, Kendle International
Inc., Argentina
„ Update of FDA Operation in Latin America
Speaker: Paul J. Seligman, MD, MPH, CAPT. USPHS
Associate Director, Safety Policy and Communication,
CDER, FDA, USA
WRAP-UP
REVIEW
Re-visit: Course objectives
Summary of lessons learned
Course evaluation
ROUNDTABLES: Three specific questions will be addressed to all regulators.
„ ISP – Chile
Moderator: Dr. Eduardo R. Johnson
Departamento Control Nacional de Medicamentos, Instituto de
Salud Pública de Chile
„ ANVISA – Brazil
Moderator: Alessandro Ferreira
DAY 2 | THURSDAY, NOVEMBER 11
7:30 - 8:30
„ ANMAT – Argentina
Moderator: Agustina Bisio
REGISTRATION
11:00 – 11:30
REFRESHMENT BREAK
PROGRAM CHAIRPERSON
11:30 – 13:00
PLENARY SESSION 2
João Massud Filho
Global Challenges with Bioethics in IRB’s Training
Universidade Federal de São Paulo
CEO/Executive Director, Newcotrials, Brazil
SESSION CHAIRPERSON
8:30 - 9:00
WELCOME AND OPENING REMARKS
Paulo Fortes
Sociedade Brasileira de Bioética, Brazil
9:00 – 9:30
KEYNOTE ADDRESS
The Importance of Clinical Research for Drug
Development
Richard O. Day
Professor of Clinical Pharmacology
St. Vincent’s Hospital, Australia
President-elect, DIA Board of Directors
SESSION CO-CHAIRPERSON
Marcelo Vianna de Lima
President, Brazilian Society of Pharmaceutical Medicine (SBMF),
Brazil; Medical Director, Latin America - Medical Diagnostics, GE
Healthcare, Brazil
US Training Programs for IRBs: What Is in Place and Is It Enough?
Marjorie A. Speers
President and CEO, Association for the Accreditation of Human
Research Protection Programs, Inc. (AAHRPP), United States
Latin American Experiences in IRB Training Programs:
Brazilian Experience
Miriam Ghiraldini Franco
Universidade Federal de São Paulo, Brazil
Latin American Experiences in IRB Training Programs:
Chilean Experience
Gustavo Kaltwasser
Bioethics Consultant, Chile
5
13:00 - 14:00 LUNCHEON
14:00 - 15:30 CONCURRENT SESSIONS
CONCURRENT SESSION 1
CONCURRENT SESSION 2
Pharmacovigilance – SAE Management
Pediatric Trials in Latin America
SESSION CHAIRPERSON
SESSION CHAIRPERSON
E. Stewart Geary
Charles Schmidt
Vice President, Eisai Co., Ltd., Japan
Brazil
SESSION CO-CHAIRPERSON
SESSION CO-CHAIRPERSON
Murilo Freitas Dias
Andre Feher
Pharmacovigilance Manager, ANVISA, Brazil
Novartis, Brazil
An Ethical Perspective: What Is to Be Paid?
Clinical Research in Pediatric Oncology
Greg Koski
Harvard University, United States
Antonio Sergio Petrilli
Instituto De Oncologia Pediátrica, Grupo de Apoio ao
Adolescente e à Criança com Câncer (GRAACC), Brazil
SAE Accountability: A Legal Perspective in Latin America
Trends on Global Pediatric Clinical Research
Claudia Mano Senise
Medical Director, PRA International, Brazil
How to Estimate SAE Costs and Controls and Audit SAE Bills
Liu Hsiang Tzu
Icon Clinical Research, Brazil
Barry Mangum
Director, Clinical Pharmacology, Duke University Medical
Center, United States
Current Obstacles to Boosting Pediatric Clinical Research
Robert M. Jacobson
Chair, Pediatric and Adolescent Medicine, Mayo Clinic,
United States
15:30 - 16:00 REFRESHMENT BREAK
16:00 - 17:30 CONCURRENT SESSIONS
CONCURRENT SESSION 3
CONCURRENT SESSION 4
State of the Art in Oncology Clinical Trial Design
Sergio Simon
Conducting Observational Studies in Latin America:
Academic, Ethical Committees and the Pharmaceutical
Industry
GBCAN, Brazil
SESSION CHAIRPERSON
SESSION CO-CHAIRPERSON
Laura Luchini
Paula Strassmann
Clinical Research Unit Director, Sanofi-Aventis Farmaceutica, Brazil
President, PGS Medical Statistics, Brazil
SESSION CO-CHAIRPERSON
SESSION CHAIRPERSON
Trial Designs in Oncology: Regular or Adaptive?
Joao Toniolo Neto
Diane Young
Novartis, United States
Escola Paulista de Medicina, Universidade Federal de São Paulo,
Brazil
How Do Investigators Understand New Designs? What Is Their
Perception? How Important Is It for the Patient?
Organizing Observational Studies in the Region Academic Perspective
Max Mano
ICESP, Brazil
Paulo A. Lotufo
Superintendent, Hospital of the University of São Paulo, Brazil
Statistics Point of View: When and Why is Adaptive Design Important?
Organizing Observational Studies in the Region Pharmaceutical Industry Perspective
Jeffrey D. Vest
Director, Biostatistics, Medpace, United States
Eduardo Forléo
Chiltern, Brazil
Regulations and Ethical Analysis of Observational Studies
Ezequiel Klimovsky
Asociado Director, QUID-Consulting SRL, Foundation for
Ethics and Quality in Latin American Research (FECICLA),
Argentina
6
10:30 – 12:00
DAY 3 | FRIDAY, NOVEMBER 12
PLENARY SESSION 4
Translational Medicine
7:30 - 8:30
SESSION CHAIRPERSON
REGISTRATION
João Massud Filho
8:30 – 10:00
Universidade Federal de São Paulo
CEO/Executive Director, Newcotrials, Brazil
PLENARY SESSION 3
How the Post-trial Access Issue Has Progressed
Throughout the World in Recent Years
SESSION CO-CHAIRPERSON
SESSION CHAIRPERSON
Eli Lilly, ICB USP, Brazil
Sonia Mansoldo Dainesi
Translating Investigation of Mood Disorders in the Treatment of
Real Patients
Medical Director, Boehringer Ingelheim, Brazil
SESSION CO-CHAIRPERSON
Sonia Barros
HIAE, Brazil
Ethical Aspects and Challenges of Post-trial Access to Study Medications
Christine Grady
Department of Clinical Bioethics, National Institutes of Health,
United States
Legal Aspects on the Donation of Nonapproved Drugs
Jair Soares
Professor and Chair; Department of Psychiatry and
Behavioral Sciences, University of Texas – Houston Medical
School, United States
Translational Medicine in Sepsis: The Critical Role of the
Microcirculation
Daniel De Backer
Erasme University Hospital, Belgium
Brazilian Experience on Translational Medicine
Angela Fan Chi Kung
Pinheiro Neto Advogados, Brazil
Luísa Lina Villa
Branch Director, Ludwig Institute for Cancer Research, Brazil
Sanitary Point of View on Post-trial Access
Patricia Ferrari Andreotti
ANVISA, Brazil
10:00 – 10:30
Mariano Janiszewski
12:00 – 13:00
LUNCHEON
REFRESHMENT BREAK
13:00 - 14:30 CONCURRENT SESSIONS
CONCURRENT SESSION 5
CONCURRENT SESSION 6
Contract and Budget Negotiations: How to Build a
Win-Win Relation Between Sponsors and Sites
Computerized Systems in Clinical Trials:
Data Quality and Integrity
SESSION CHAIRPERSON
SESSION CHAIRPERSON
Marlene Llopiz-Aviles
Silvia Zieher
Regional Director for Latin America, Venn Life Sciences, Mexico
SESSION CO-CHAIRPERSON
Senior Director, Head of Clinical Operations Latin America,
INC Research, Argentina
Gustavo Luiz F. Kesselring
SESSION CO-CHAIRPERSON
Director, Clinical Trials Operation, Hospital Alemao Oswaldo Cruz,
Brazil
Marcelo Alexandre Costa Vaz
ICON, Brazil
Perspective from the Sites
An Overview of Best Practices from PEACH
Luis Augusto Tavares Russo
Director, CCBR Brasil, Brazil
Earl Hulihan
Senior Vice president, Regulatory Compliance
Medidata Solutions Worldwide, United States
The Top 10 Ways to Impede the Independent Research Site
Jeffrey M. Adelglass
President and Chief Executive Officer, Research Across
America, United States
Partnership with Sites
Mariana Pauli
PPD, Argentina
US FDA’s Regulation of eRecords and eSignatures in Clinical
Investigations
Sean Kassim
Division of Scientific Investigations, Office of Compliance
CDER, FDA, United States
The Use of Cloud Computing in Medicine and Research: A Blessing or a
Curse - A Practical Discussion
Glenn Watt
Corporate Security & Privacy Officer, Vice President, Global
Information Security and Privacy, Medidata Solutions, Inc.,
United States
14:30 - 15:00 REFRESHMENT BREAK
7
15:00 - 16:30 CONCURRENT SESSIONS
CONCURRENT SESSION 7
CONCURRENT SESSION 8
Effects of the 2008-09 Global Economic Crisis
on Clinical Development and How Biopharma Is
Responding
The Implications of Late Phase Research on Drug
Development
SESSION CHAIRPERSON
Oscar Podestá
Dennis P. Hurley
General Manager, Latin America, Chiltern International Inc.,
Argentina
Vice President of Latin America, Kendle International, United States
SESSION CHAIRPERSON
SESSION CO-CHAIRPERSON
SESSION CO-CHAIRPERSON
Jose Luiz Cordeiro Dias Tavares
Melissa Brosset
Director, Roche, Brazil
Gotuzzo Asociados Sac, Peru
Trends in the Overall Number of Trials and Sites: Global Distribution
and Disease Focus
Fabio Thiers
Director, Global Clinical Trials Research Program, MIT Center
for Biomedical Innovation, United States
Big Biopharma Trends
Julio E. Camps
Director, Regional Head for Latin America, Amgen Inc.,
United States
The Shifting Focus on Global Biopharmaceutical R&D: New Innovation
Models and Strategies
Clinical Research Beyond Registration
Jaderson Socrates Lima
Medical Director, Sanofi-Aventis, Brazil
Compliance Challenges in Late Phase Projects
Daniel Ciriano
Medical Director / PDO Country Operation Manager,
Productos Roche S.A.Q.el., Argentina
Pharmacogenomics in the Brazilian Population and Its Implications
on Local Clinical Studies
Guilderme Suarez-Kurtz
INCA, Brazil
Kenneth I. Kaitin
Director, Center for the Study of Drug Development and
Professor of Medicine, Tufts University School of Medicine,
United States
16:30 WORKSHOP ADJOURNED
Unless otherwise disclosed, DIA acknowledges that the 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.
8
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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.
Maksoud Plaza Hotel (Meeting Venue)
L´Hotel
Phone: (55 11) 3145-8000 - Ext. 8761 / Fax: (55 11) 3145-8001
eMail address: [email protected]
Website: www.maksoud.com.br
Phone: (55 11) 2183-0500 / Fax: (55 11) 2183-0505
eMail: [email protected] /
Website: www.lhotel.com.br
Special Daily Rates:
Low Cost Room (3-6 floors)
z
Sgl R$ 265,00 + 5,26% (ISS) + R$ 1.20 Tourism Tax
Dbl R$ 310,00 + 5,26% (ISS) + R$ 1,20 Tourism Tax
Standard Room (7-10 floors)
z
Sgl R$ 344,00 + 5,26% (ISS) + R$ 1.20 Tourism Tax
Paulista Flat Service
Phone: (55 11) 3251-2488 / Fax: (55 11) 3251-2909
eMail: paulista@paulistaflat.com.br
Website: www.paulistaflat.com.br
Dbl R$ 389,00 + 5,26% (ISS) + R$ 1,20 Tourism Tax
Executive Superior Room
z
Sgl R$ 450,00 + 5,26% (ISS) + R$ 1.20 Tourism Tax
Dbl R$ 505,00 + 5,26% (ISS) + R$ 1,20 Tourism Tax
Tower Premium Room
z
Sgl R$ 535,00 + 5,26% (ISS) + R$ 1.20 Tourism Tax
Dbl R$ 590,00 + 5,26% (ISS) + R$ 1,20 Tourism Tax
Please note: The location of the above hotels is within walking
distance from the venue; for more options, see http://www.hotels.com.
br/estados/sp/sao_paulo.html (select: Jardins and Jardins Paulista).
Congress Planning: Managing Eventos - Phones: (55 11) 5587-5232 /
(55 11) 3208-2786 (fax); eMail address: [email protected]
NOTES:
1) The above room rates are in Reais (R$); for prices in dollars, please check the daily exchange rate (http://www.x-rates.com/calculator.html - select
Brazilian Real into American Dollar);
2) Refer to the “7th Latin American Congress of Clinical Research - DIA/SBMF” to get the above special rates.