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 • • • • • • • •
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
• • • • • • •
8:40-10:00 Hands-on the Brazilian Regulations • • • • • •
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 • • • • • •
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 • • • • • • •
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 • • • •
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.
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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)
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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)
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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
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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.