22 July 2009
10:00–11:30 am ET

Recently, sponsors have been moving their clinical trials from traditional regions to emerging markets like Latin America. The Latin American market offers several benefits and distinguishing characteristics that have made this market more appealing for drug developers, including its geographic proximity to the US, significantly reduced trial costs and language homogeneity.

In this Webcast featuring a distinguished panel of in-country regulatory experts, you will learn about the recent regulatory changes and challenges affecting Mexico, Brazil, Peru, Colombia, Argentina and Chile. Regulatory experts from each key Latin American country will discuss the competitive advantages and potential challenges that will better prepare you to do business in Latin America. You and your company will also benefit from hearing experts provide solutions to common challenges faced during clinical trial stages.

Professional Levels: I, II, III

Learning Objectives:
Upon completion of this Webcast, participants should be able to:

• List the key countries involved in drug development in Latin America
• Understand what differentiates Latin America from other markets
• Identify key advantages to conducting clinical trials and developing drugs in Latin America
• Recognize common challenges facing the Latin America market and be prepared with resolutions
• Be aware of common challenges and recent updates in Latin America

Who Should Attend:

• Regulatory professionals and companies who are either planning or are currently engaged in regulatory activities in Latin America
• Professionals interested in learning about clinical research in Latin America
• Professionals interested in drug development in Latin America

Speaker(s):

Panel of Regulatory Experts from Mexico, Brazil, Peru, Columbia, Argentina, and Chile:

Mirtha Lipezker, MD, senior director global clinical development, country manager, Kendle Mexico
Mirtha Lipezker, MD, has more than 12 years of CRO experience as well as strong clinical development experience across 15 therapeutic areas. Lipezker is actively involved in the management and formation of clinical staff, especially project managers throughout Latin America. She has personally managed successful key registration trials while based in both Mexico and in the USA. Her professional education and professional activities have been carried out in the US, Latin America and Europe. Lipezker holds a medical degree from La Salle University in Mexico City, and completed her training in psychiatry at one of the leading psychiatric hospitals in Mexico City. She is member of the Mexican Psychiatry Association and DIA.

Alcione Braga, RPH, MBA, director global clinical development, country manager, Kendle Brazil
Alcione Braga has 19 years combined experience in the pharmaceutical industry in positions of increasing responsibility in clinical trials with Servier, Pharmacia, Searle and Farmitalia Carlo Erba. Braga has experience and in depth knowledge of managing clinical research trials in Brazil, having worked in many key therapeutic areas. She is a Registered Pharmacist and holds postgraduates diplomas in science of medicine-drugs, clinical trials, and an MBA in business management. In addition, Braga has worked closely with the Brazilian Ministry of Health (MoH) as a trainer and in MoH-supported multicenter trials.

Jacqueline Zeuner, MSc, director global clinical development, country manager, Kendle Peru
Jacqueline Zeuner has worked as a trial coordinator and clinical research associate (CRA) and in regulatory affairs for several large pharmaceutical companies. Prior to her current position, she was a clinical operations manager, training and managing CRAs and implementing the quality program in Eastern Europe, the Middle East, Africa, Asia and Latin America. Her therapeutic experience includes oncology, respiratory, cardiology, diagnostics, infectious diseases, endocrinology and gynecology. She holds a master’s degree from the University of ETH in Zurich, Switzerland with focus on cell biology, anatomy and physiology, genetics, immunology and biochemistry. She has 15 years of clinical research experience. She currently is also a regional project leader for Latin America, and has a sound knowledge of clinical trial regulations and international experience.

Mariagabriela Alterio, MSc, director global clinical development, country manager, Kendle Colombia
Mariagabriela Alterio has more than 10 years experience in the clinical research and pharmaceutical industry, including the post of clinical research manager in Colombia for a large global pharmaceutical company. She has broad experience and in-depth knowledge managing clinical research trials in all the major Latin American countries, having worked in 10 key therapeutic areas. She has experience as a clinical research associate, clinical research coordinator and research manager for Latin America. Alterio has postgraduate training in biology, clinical research and bioethics. She holds a master’s degree in biology (emphasis in immunology and virology) from Johannes Gutenberg Universitaet Mainz, Germany. She is a member of DIA and the Colombian Association for Clinical Research-Avanzar. She is also an instructor in GCPs and ethics in clinical research at the Universidad El Bosque, Bogota, Colombia.

Raul Bozzo, MD, director global clinical development, Kendle Argentina
Raul Bozzo, MD has been involved in clinical research for more than 20 years and has published numerous abstracts, reviews, and clinical study reports in cardiology and other areas of internal medicine. He was previously the medical director of a Latin American regional CRO, with offices in five South American countries. He has worked as an R&D clinical research manager and project manager at GD Searle Laboratory and an R&D clinical research associate and medical advisor Sintyal Laboratory. He also has held clinical positions at Favaloro Foundation and served as staff physician of the multi-organ transplant unit. Bozzo holds an MD from the University of Buenos Aires, and completed an internal medicine residency in the Italian Hospital and a cardiology fellowship at Favaloro Foundation, where he was appointed head fellow in cardiology. He is certified in clinical pharmacology and echocardiography. He is a member of DIA, the Argentinean Society of Medicine, and the Argentinean Society of Cardiology.

Cost: Members: $295 USD; Nonmembers: $395 USD
Cost is per site - unlimited participants