8 Latin American Congress on Clinical Research Latin ...

[Pages:4]8th Latin American Congress on Clinical Research Latin America Role in Worldwide Clinical Research

APrper-icl o19n-g2r1e, s2s0c10ourseTsu:toOrciatolsb: Aerp1r9il,1280, 211010 MCoarnrigotrteBsest:hOescdtaoNboerrth20Ho-2te1l,&2C0o1n1 ference Center, Bethesda, MD, USA Panamericano Hotel & Resort, Buenos Aires, Argentina

CONGRESS CHAIRPERSON Juan Carlos Groppa, MD Past President, SAMEFA (Argentine Society of Pharmaceutical Medicine) Medical Affairs Manager. Laboratorios B?go S.A., Argentina

SCIENTIFIC COMMITTEE CHAIRPERSON Hugo Cohen Sabban, MD President, SAMEFA (Argentine Society of Pharmaceutical Medicine) CEO, CRO BIOSOLUTION, Argentina

SCIENTIFIC COMMITTEE Sebasti?n Batagelj, MD Medical Advisor, Laboratorios Bag?, Argentina Daniel Ciriano, MD Medical Director - Roche Argentina Andrea Costantini, MD Medical Advisor, Phoenix Laboratories, Argentina Luis Collia, MD Medical Director, Laboratorios Craveri, Argentina Wanda Dobrzanski, MD Medical Director, Medical & Scientific Affairs, Respiratory and Infectious Diseases, i3 Global, Argentina Rosana Felice, MD Medical Director, Argentina & Southern Cone, GlaxoSmithKline, Argentina Gustavo Fischbein, MD Medical Director, Osmotica Pharmaceutical, Argentina Pablo Hammerschmidt, MD Regional Director, Clinical Operations, ICON Clinical Research, Argentina Gabriela Kivelevitch, MD Medical Advisor, Laboratorios Phoenix, Argentina Sandra Mercurio, MD Medical Director & Lead Nominated Signatory, AstraZeneca , Argentina Luis Pliego, MD Regional Medical & Regulatory Affairs Manager, Janssen-Cilag, Argentina Luis Ramirez, MD Regional Head Clinical Operations for Latin America, Boehringer-Ingelheim, Argentina Rosa Scuteri, MD Medical Advisor, Laboratorio Raffo , Argentina Daniel Vazquez, MD Senior Director and Latin America Head, Global Regulatory Affairs, Quintiles Argentina S.A., Argentina Marcelo Vianna de Lima Medical Director, Latin America , Medical Diagnostics, GE Healthcare, Brazil Silvia Zieher, MD Executive Director, Latin America Operations, INC Research, Argentina

All registrations will be processed by Samara & Enrique (Meeting Planners) Contact Information for Registration and Tabletop Opportunities Roxana Samara, Exhibits Department +54 9 11 5664 0160 / +54 11 4774 7531 Email address: roxana@samara-.ar Registration Link: samara-.ar/dialatam2011

DIA Program Contact Information Constance Burnett, Program Developer +1 215.293.5800 (tel) | email:Constance.Burnett@

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

? Cell-Based Therapies: The New Drug Class ? Latin America Regulatory Affairs Update ? First Time in Man & Early Phase Trials ? The Contribution of Latin America to Data Quality on Marketing

Applications ? Clinical Safety and Pharmacovigilance ? Ethical Issues: A Permanent Dilemma ? Endpoints, Surrogates and The Rationale on Study Design ? Streamlining Logistics in the Region ? Sponsoring of Clinical Research by Nontraditional Players ? Biosimilars and the road ahead

PRECONGRESS COURSES

October 19th # 1 Risk Project Management # 2 Clinical Quality Assurance: The Basics

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) ? CROs and SMOs ? Service providers

? Clinical investigators (active and potential)

? Ethics committees ? Regulatory agencies ? Medical education institutions ? Pharmaceutical sponsors

Simultaneous Translation will be available in Portuguese, English, and Spanish

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

Co-sponsored by

DAY 1 | WEDNESDAY, OCTOBER 19TH

08:00-08.45

REGISTRATIONS

09:00?06.30

PRE-CONGRESS TUTORIALS

Tutorial 1: Risk Project Management

Course Director

Mr. Marty Hynes III Six Sigma Champion, Senior Director Product R&D, Lilly Research Laboratories, Ely Lilly and Company

Tutorial 2: Clinical Quality Assurance, the Basics

Course Directors

Ezequiel Klimovsky Associate Director, QUID -Quality in Drugs and Devices- LATAM Consulting SRL, Argentina

Margarita Eiletz Managing Director, Ethics & Excellence SRL, Argentina

DAY 2 | THURSDAY, OCTOBER 20TH

07:00-08.00

REGISTRATIONS

08:00-08:30

OPENING

Welcome and Introduction to DIA 2011

Session Chairpersons

Juan Carlos Groppa (SAMEFA) Argentine Society of Pharmaceutical Medicine Medical Affairs. Laboratorios B?go S.A., Argentina

Yves Julliet (DIA) DIA President, USA

12:30?02:00 02:00-04:00

LUNCHEON CONCURRENT SESSIONS

Round Table: Biosimilars in Latin America

Session Chairperson Joao Masssud Trials Consulting, BRASIL Session Co-Chairperson Daniel Mazzolenis General Manager, Kendle , Argentina

Studies with Biologicals in Latam Julio Camps Regional Director, Latin America, Amgen Development Operations, USA

Studies with Biosimilars in LatAm Speaker to be confirmed

B&B Development Dilemmas for Latin American Companies Roberto Diez Clinical Research Manager, Bio Sidus S.A., ARGENTINA

04:00?04:30

REFRESHMENT BREAK

2

08:30-10:00

PLENARY SESSION

Conference: Adult Mesenchymal Stem Cells are the New Medicine for Diseases

Session Chairperson

Mar?a Jimena Fern?ndez Bartolom? Monitora Estudios Clinicos, Roche, Argentina

Speaker

Arnold Caplan Director, Skeletal Research Center, Professor of Biology and General Medicine Sciences, Case Western Reserve University, Cleveland Ohio, USA

10:00?10:30

REFRESHMENT BREAK

10:30-12:30

PLENARY SESSION

Round Table: Medical Devices ? Clinical Trials

Session Chairperson

Marcelo Vianna de Lima Medical Director, Latin America - Medical Diagnostics, GE Healthcare, Brazil

Session Co-Chairperson

Hugo Cohen Sabban President, SAMEFA (Argentine Society of Pharmaceutical Medicine) CEO, CRO BIOSOLUTION, Argentina

Local Requirements to Running Studies with Devices

Marta Kaufman ANMAT (Administraci?n Nacional de Medicamentos, Alimentos y Tecnolog?a M?dica), Argentina

Experiences from FDA Inspections on Clinical Trials with Devices in the Latin American Region

Matthew J. Tarosky Acting Director, Division of Biosresearch Monitoring Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA Captain, U.S. Public Health Service

I Have a Device, and Now?

Hugo Kuprinsky Specialist in Obstetrics, CEMIC, Argentina

Round Table: The contribution of Latin America Data to Marketing Applications: a Focus on Quality

Session Chairperson Silvia Zieher Executive Director, Latin America Operations, INC Research, Argentina

Ethical and GCP Standards in Latin America: a General Overview of the Research Ethics Committees and Regulatory Framework Anna Paula M?s Associate Director, Global Regulatory Development, Latin America, Global Regulatory Affairs, Brasil

An Overview of FDA Inspections Experience in Latin America. FDA Interactions with Local Regulatory Agencies Paul Seligman Director, FDA Latin America Office Latin America Regional Office, Costa Rica

EMA Inspections Experience in Latin America and Impact of the Reflection Paper 2010 Fergus Sweeney, EMA (via teleconference) Head of Sector Compliance and Inspections EMA (European Medicines Agency), United Kingdom

04:30-06:30

CONCURRENT SESSIONS

Round Table: Issues in Logistics within the Region

Session Chairperson

Cecilia Dantuono Site Manager, Bristol Myers Squibb, Argentina

Session Co-Chairperson

Daniel Vazquez Senior Director and Latin America Head, Global Regulatory Affairs, Quintiles Argentina S.A, Argentina

Local Requirements Marina Ordo?ez Clinical Site Manager, Bristol Myers Squibb, Per?

Topic to be Confirmed Antonela Mangiaterra Associate Manager, Clinical Logistics, PAREXEL International Clinical Logistics Services | Latin America, Argentina

Topic to be Confirmed Flavio Echemendigaray Warehouse Manager, Genzyme, Argentina

DAY 3 | FRIDAY, OCTOBER 21ST

07:00-08.00

REGISTRATIONS

08:00?08:30

IFAPP CONFERENCE

Session Chairperson Luis Collia

Medical Director, Laboratorios Craveri, Argentina

Speaker Norbert Clemens Head Clinical Development, CRS Clinical Research Services

Mannheim GmbH, Germany

08:30-10:00

PLENARY SESSION

Conference: Early Phase Trials

Session Chairperson Leylen Colmegna CEO, LAT Research, Argentina

Introduction to Early Phase Trials Leylen Colmegna CEO, LAT Research, Argentina

What is Needed to Conduct Early Phase Trials in Humans Speaker to be confirmed

Today?s Latin American Experience in Early Phase Trials Speaker to be confirmed

01:00?02:00 02:00-04:00

LUNCHEON CONCURRENT SESSIONS

Round Table: Sponsoring Clinical Research by Non Traditional Players

Session Chairperson Mario Boskis Chairman and CEO, ActivaCro, Argentina

Co-Session Chairperson Fernando Martinez Executive Director Global Operations, inVentiv Clinical Solutions LLC, Madrid, Spain

Public and Private Consortiums in Latin America for the Development of Innovative Products Hugo Sigman CEO, Chemo Group, Argentina

Innovations in Latin America. Fiction or Reality?: An Inventor?s Perspective Juan Carlos Parodi Consultant, Vascular Surgery Department , FLENI, Argentina

Neglected Diseases: From Discovery to Availability to Patients. A New Paradigm in R&D Isabela Ribeiro Head of Chagas Clinical Program, Drugs for Neglected Diseases Initiative (NDDI), Sao Paulo, Brazil

3

Round Table: Understanding the Rationale behind the Design of Clinical Research: What Endpoints and Surrogates Intend to Demonstrate

Session Chairperson

Gustavo Fischbein Medical Director, Osmotica Pharmaceutical Argentina

Session Co-Chairperson

Marlene Ll?piz Avil?s CEO - CRO Mexicana, S.C. CEO - CRO Mexicana, S.C. Mexico

Objectives in Cardiovascular Research Daniel R. Nul Medical Director, Cl?nica Constituyentes, Argentina

Objectives in Oncology Research Speaker to be confirmed

Objectives in CNS Research Gonzalo G?mez Ar?valo Director, Phvlatam, Argentina

10:00?10:30

REFRESHMENT BREAK

10:30-12:30

PLENARY SESSION

Round Table: Latin American Regulatory Affairs Update

Session Chairperson Speaker to be confirmed

Session Co-Chairperson Daniel Vazquez Senior Director and Latin America Head, Global Regulatory Affairs, Quintiles Argentina S.A., Argentina

Update on Current Clinical Research Regulations Status in Different Latin American Countries Flavia Regina Souza Sobral Specialist in Regulation and Sanitary Surveillance, Anvisa National Agency of Sanitary Surveillance, Brasil Representatives from Argentina, Chile, Mexico and Per?

12:30-01:00

PLENARY SESSION

Conference: Pediatric Drug Development.

An FDA Perspective

Speaker Benjam?n Ortiz Medical Officer, International Team Office of Pediatric Therapeutics, Office of the Commissioner, US Food and Drug Administration

Round Table: Clinical Safety and Pharmacovigilance

Session Chairperson Gerardo M?ndez Ciancaglini Product Information & Consumer Service Department Head, Laboratorios Bag? S.A., Argentina

PV outlook: National and International Companies Perspective Are Both Looking for the Same? Speaker to be confirmed

Current Standards Mariano Madurga Head of Pharmacoepidemiology and Pharmacovigilance Area, Pharmacoepidemiology and Pharmacovigilance Division, Medicines of Human Use Department , Spain

CDER Current Experience George Rochester Associate Office Director for Safety Assessment, Office of Biostatistics CDER, FDA

04:00?04:30 04:30-06:30

REFRESHMENT BREAK CONCURRENT SESSIONS

Round Table: Ethical issues: A Permanent Dilemma

Session Chairperson Sandra Mercurio Medical Director & Lead Nominated Signatory, AstraZeneca, Argentina

Session Co-Chairperson Wanda Dobrzanski Nisiewicz Medical Director, Medical & Scientific Affairs, Respiratory and Infectious Diseases, i3 Global, Argentina

Post Trial Treatment Patricia Said?n Specialist in Neurology and Independent Consultant, Argentina

The New Vulnerable Populations Mar?a L?pez Bresnaham VP and Global Head, Medical and Scientific Affairs, i3, USA

Transforming Interactions with HCP?s Regina Kuchle Legal Director and IP Consultant for LATAM, ASTRA ZENECA, MEXICO

4

Round Table: Latin America - Educational Options in Clinical Research

Session Chairperson Juan Carlos Groppa Past President, SAMEFA (Argentina Society of Pharmaceutical Medicine) Medical Affairs Manager. Laboratorios B?go S.A., Argentina Speakers Speakers and topics to be confirmed

06:30

CONGRESS 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.

Travel and accommodation in Buenos Aires

The City of Buenos Aires has two airports: ? Ministro Pistarini International Airport in Ezeiza, 45 kms from downtown Buenos Aires, connecting the city with the rest of the world ? Jorge Newbery International Airport, only 15 minutes from downtown Buenos Aires, connecting the city with the rest of the country

and some Latin American destinations. The city has efficient radio-taxi and car rental services, available the 24 hours. Buses and a broad underground network facilitate the access to every corner of the city.

Where to stay

Buenos Aires is a city of intense cultural life, with plenty of diverse touristic attractions. All choices of hotels and accommodations are possible. Take a moment to visit .ar to find out rates of different hotel categories.

Hotel information and reservations for congress attendees

In order to receive discounted room rates at Panamericano Hotel & Resort, reservations MUST be made through the Congress organizers. You must be registered for the Congress to reserve your room Please, contact dialatam2011@samara-.ar directly to make your hotel reservation or for information on other conveniently located hotels nearby the congress venue.

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