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.

8 HOTEL RESERVATION FORM Family Name ___________________________________________________

First Name ____________________________________________________

Company _______________________________________________________________________________________________________________________ Address ________________________________________________________________________________________________________________________ City _____________________________________ State _____________ Zip/Postal Code _________________ Country _____________________________ Telephone _____________________________________________________

Fax __________________________________________________________

email __________________________________________________________________________________________________________________________ (email address required for receipt of reservation confirmation.)

PAYMENT / RESERVATION MUST BE GUARANTEED WITH A CREDIT CARD. Credit Card Type:   ‰ MasterCard    ‰ Visa    ‰ Diners Club    ‰ American Express    ‰ Other _____________________________________________ Card Number ____________________________________________________________________ Expiration Date __________________________________ Name of Card Holder _____________________________________________

Signature _______________________________________________________

ROOM INFORMATION Please Circle: Standard

/

Double

Single/queen bed

/

Double/twin beds

Arrival date _________________________

Arrival time _________________________

Departure date ______________________

Departure time ______________________

Check-in time: 15:00 o’clock, check-out time: 12:00 o’clock. Fax this form to the fax number listed below for your preferred hotel. DO NOT FAX HOTEL RESERVATION FORMS TO DIA OR MANAGING EVENTOS.

TRAVEL AND HOTEL The most convenient airport is Guarulhos International Airport (GRU), which is approximately 20 miles from the hotels. Attendees should make airline reservations as early as possible to ensure availability. The hotels below are optional (estimated rates); for other information or reservations, contact the hotel offices directly. 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.