Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

This audio conference covers:

• Pros and cons of including Latin America in your development program
• Latin American capabilities for clinical research
• The regulatory process and environment
• Latin American statistics and culture
• Challenges of conducting clinical research programs in Latin America

About the speaker:

Federico Ezequiel Lerner, MD, PhD, is Senior Director of Operations for PRA International, based in Argentina, and is responsible for the successful management of all operations in this region. Prior to joining PRA in 2009, Dr. Lerner acted as senior director at two global CROs, manager at ClinPhase One Group, a regional CRO, and co-investigator at Cartesius Analytical Unit and Miguel Servet Clinical Pharmacology Unit in Sao Paulo, Brazil. He has held several teaching positions at major universities in Argentina and Brazil, and has published several papers in both basic and clinical research.

Dr. Lerner is member of the American College of Clinical Pharmacology, Drug Information Association, American Society of Pharmaceutical Physicians and Argentina Medical Association. He received his MD from Buenos Aires University and was a doctoral research fellow at Campinas State University in Sao Paulo, Brazil.

Who should attend?

• Heads of Latin America
• Directors of Research & Development
• Clinical Study Managers
• Regulatory Affairs Directors/Managers
• Project Directors/Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.