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Premiere Event!
Simultaneous Translation Services Available
Participants will
receive a Continuing Medical Education Certificate, through the
support of Universidad Anahuac Medical School.
MEETING OBJECTIVES:
The forum will include a pre-congress course,
covering the most important topics for the optimal conduction of
clinical research protocols. A comprehensive review will be made on
ethical issues on GCP, ICH, informed consent, ethical review,
completion of CRFs, budget development, and sponsor and FDA audits.
The congress will update the most concerning ethical and
harmonization issues in Latin America. Ethics, genetics and
regulatory issues will be compared between the USA and Latin
America. The forum will provide a futuristic view on clinical
research in Latin America and its participation in global research.
It will foster an open discussion on clinical investigation in Latin
America for future partnerships with the pharmaceutical industry.
KEYNOTE ADDRESS:
Representatives
from the Ministry of Health of Mexico (SSA) & the Food and Drug
Administration (FDA) have been invited to speak about The Importance
of Globalization of Clinical Research in Latin America
PRE-CONGRESS
COURSE – February 27, 8:15-18:00
“Armamentarium for
Good Clinical Research” will include presentations on: Training of
Physicians in Clinical Research; Phases of Clinical Research;
Regulatory References; Good Clinical Practices; Ethics; Informed
Consent; Perspectives of ICH; Institutional Review Boards and FDA
Requirements; Elements for the Successful Conduct of a Research
Protocol; Financial Aspects in Clinical Research; Electronic
Signature and Registry; Preparing for Inspection, Monitoring and
Audits.
CONGRESS
HIGHLIGHTS – February 28, 8:00 - March 1, 18:45
Representatives
from the Ministries of Health of several Latin American countries
(Argentina, Brazil, Chile, Venezuela and Mexico), the Pan-American
Health Organization and the Food and Drug Administration from the
USA, along with representatives and authorities in clinical research
ethics, academia and industry from Latin America, Europe and the USA
have been invited to participate in sessions focusing on these
topics:
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Ethics and
Clinical Research – Historic Retrospective in Research; Ethical
Aspects of Clinical Research; Ethics and Scientific Committees;
Protection of the Study Subject; Clinical Investigators’ Conflicts
of Interest; Importance and Ethical Aspects of Placebo, Research
in Pediatrics, Incapacitated and Terminal Patients; Compliance
with Ethics and Surveillance in Latin America.
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Regulatory
Aspects of Clinical Research in Latin America – Regulatory
Guidelines in Accordance with ICH/FDA; Regulations in Clinical
Research in Latin America; A Pan-American Network for Drug
Regulation Harmonization.
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Differences
Between Clinical Research in the USA and Latin America – Ethnic
and Cultural Differences in Drug Development in Clinical Research;
Genetic Variability in Drug Response from a Pharmacogenomic Point
of View; Representation of Minorities in Clinical Research in the
USA; Drug Development in the Americas from Phase I through IV
Clinical Trials; Criteria for Clinical Trial Site Selection in the
USA and Latin America.
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The Future of
Clinical Research – Ethical, Scientific and Therapeutic Aspects of
the Study of the Human Genome in Latin America; Arising and New Challenges of Pediatric Clinical
Research; Future of Generics and Bioequivalence Studies in Latin
America; Preparing for the Future of Clinical Research in Latin
America; Perspectives of CRO's in Latin America; Success or
Failure in Clinical Research in Latin America - Learning from
Experience; Drug safety and risk management-a new challenge for
drug development; Clinical Research in Vaccines for the new
millennium: Preventing disasters?; Future of Clinical
Research from the 21st Century on - Technological Resources and
Marketing.
These sessions will
include Roundtable Question & Answer Periods without
interruption by exposition segments.
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Program
Chairpersons:
Roberto
Chiprut, MD, FACP
General Director, Mexican Institute of Clinical Research,
Mexico; Clinical Professor of Medicine, UCLA, USA;
Attending Physician, Cedars Sinai Medical Center, USA
Héctor A.
Bolaños
Executive Director, AFAMELA, Mexico
Program
Committee:
Dr. Alberto
Lifshitz
General Director of Drugs and Health
Technologies, S.S., Mexico
Dr. Alfonso
Moguel
President, AMEIFAC
Mr. Kenneth
Getz
President and Chief Executive Officer
CenterWatch, Inc., USA
Dr. Misael
Uribe
Coordinator of the National Institutes of Health
Ministry of Health, Mexico
Dr. Sergio
Guerrero
IMIC, Mexico
Lic. Adolfo
Dorenbaum
Chief Financial Officer, IMIC, Mexico
Dr.
Alejandro Castellanos
Principal Investigator, IMIC, Mexico
Dr.
Cristina Torres
General Director in Mexico, Quintiles, Mexico
Dr.
Itzigueri Robles
ICRO Novartis
Dr. Tomás
Barrientos Fortes
Dean of the School of Medicine, Anahuac University
Ms. C.M.
Katie Margules
PPD Development
Dr. Alberto
Frati Munari
Director of Medications SSA
Dr. Richard
Musselman
President and Chief Executive Officer
AvAMed Consulting Group, USA
Dr. Barbara
Geiger
Clinical Research Management Services
Dr. Maria Elena Cortés
Director of Education, IMIC, Mexico
Dr. David Sotres
General Director, ECA, Mexico
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REGISTER
ONLINE!
VISIT
THE
DIA
WEBSITE:
www.diahome.org
Or download the
registration below:
-
Download -
Program & Registration Form:
(PDF 132K )
 Should you have any questions
regarding this program, please contact:
Lori Risboskin at 215-591-3306 or fax: 215-641-1229 or email
lori.risboskin@diahome.org
Participants will receive a Continuing Medical
Education Certificate, through the support of Universidad Anahuac
Medical School. |
