Latin America is among the top emerging regions in the world for clinical research, and provides expanding opportunities for biopharmaceutical product development. The region offers rapid access to patients, lower costs of conducting clinical studies, and availability of highly trained professionals for clinical development. Latin America also offers attractive end markets for biopharmaceutical products.

Currently, more than 80% of the regional market share of pharmaceutical sales and growth is distributed among Argentina, Brazil, and Mexico. However, leading biopharmaceutical companies are starting to uncover new opportunities in other Latin American countries, including Costa Rica, the Dominican Republic, Ecuador, Guatemala, Panama, and Venezuela, that have not been traditionally tapped for clinical development. The speakers will review how to unlock this potential through proper planning and a risk-managed approach.

Drawing on extensive expertise, first-hand knowledge, and experience, these experts discuss how biopharmaceutical companies can achieve clinical trial success for both in-country and international marketing approvals. The speakers discuss the pros and cons of conducting clinical research in "non-traditional" Latin American countries, and provide key risk-based approaches.

This audio conference covers:

• Case examples and strategies for clinical development success in Latin America
• Opportunities and challenges of conducting product development in the region
• Therapeutic strengths by country
• Study planning best practices
• Approaches to drive and sustain recruitment
• Key regulatory issues and proactive regulatory and business risk management

About the speakers:

Dr. Alberto Grignolo, Corporate Vice President and General Manager, PAREXEL Consulting, is responsible for managing a consulting staff operating throughout Europe, North America, and Japan. He oversees regulatory and development strategy consulting, regulatory submissions management, and Regulatory Authority relationship management consulting in all regions. With more than 23 years of experience in regulatory affairs, Dr. Grignolo has worked with biopharmaceutical companies on regulatory strategy, development programs, and in preparations and meetings with the FDA and other regulatory agencies. He has handled negotiations with regulatory agencies along the full continuum of drug development and across a range of therapeutic areas. Dr. Grignolo represents the Association of Clinical Research Organizations (ACRO) on the Executive Board of the Clinical Trials Transformation Initiative (CTTI), established by FDA in collaboration with Duke University to increase the quality and efficiency of clinical studies.

Diego Glancszpigel, is Vice President, Latin American Operations at PAREXEL International. He has 16 years of experience in Clinical Research focused on helping companies develop regulatory strategies for clinical trials in Latin America, and budget planning for investigational projects in phase I, II, III and IV in therapeutic areas including Cardiology, Infectology, Women's Health, CNS and Oncology. He has leadership responsibilities for PAREXEL's Latin American Operations including presence in seven Latin American Countries. Mr. Glancszpigel is currently President of the Argentinean CRO Association.

Graciela Carlota Rácaro is Senior Director, Clinical Operations and Peri-Approval Clinical Excellence (PACE), Latin America at PAREXEL International. She is responsible for all clinical and regulatory activities in Latin America. Ms. Rácaro has expertise in drug development and non-clinical and clinical research. Her clinical experience includes clinical trial monitoring, site evaluation and initiation, data collection and quality control, and compliance with FDA/EMEA regulations and GCP guidelines. Her background includes serving as clinical lead and project manager for Latin America projects as well as global programs. She has expertise across a broad range of therapeutic areas. Ms. Rácaro holds BCh. and Pharm. degrees from the College of Pharmacy and Biochemistry at the University of Buenos Aires, and completed her Master's degree in Clinical Research and Clinical Trials Monitoring at the University Maimónides College of Medicine in Buenos Aires. Ms. Rácaro has received scientific production awards for her work on drug development teams, speaks regularly at industry conferences and has authored numerous articles on key industry topics.

Who should attend?

• Clinical Trials Directors and Management
• Regulatory Directors and Management
• Heads of Emerging Regions
• Outsourcing Personnel
• Product Strategy Directors and Management
• Business Development Officers

This audio conference is rated General Interest.