Vaccines have reduced the morbidity from vaccine-preventable diseases by up to 100% in the 20th century.
Global, vaccine mega trials can be extremely challenging for many reasons – everything from needing to quickly recruit difficult to enroll patient populations, to resourcing and trial logistics in high burden countries.
With a population of more than 580 million across 23 countries and a diverse ethnic mix, Latin America is proving increasingly attractive option for clinical trial development. The Latin American population exhibits a particular epidemiological profile and the prevalence of risk factors and diseases is similar to that within the EU or the US.
Many Latin American countries are realizing the importance of clinical research as an export services. This is helping to shape a more predictable regulatory environment with faster study start up and stronger IP protection. Learn how to navigate the regulatory landscape and to identify the right countries/sites for successful vaccines clinical studies (from phase II to IV) in Latin America.
Register today to hear industry experts offering key insights which will help you gain a better understanding of the opportunities and challenges when conducting vaccines studies within Latin America. Case studies will be used to help underpin some of the key considerations and to demonstrate particular learning points. Through connecting these insights with superior delivery, we can help you improve the probability of success of your trials in Latin America. Join us to learn more about:
- Seasonality and epidemiology
- SOC and National Immunization Programs
- Infrastructure and operational considerations
- Regulatory & start up
Valeria Staffolani, Associate Medical Director, ARIDV- Pediatric Center of Excellence
Dr. Valeria Staffolani is an Associate Medical Director in the Allergy, Respiratory, Infectious Diseases and Vaccines Therapeutic Delivery Unit, and a member of the Quintiles Pediatric Center of Excellence. Since joining Quintiles in 2006, Dr Staffolani has served as Medical and Scientific Advisor in the following indications: community acquired and nosocomial pneumonia, fungal infections, influenza, shigatoxin-producing bacterial infections in children, pediatric hypertension, pediatric migraine, HIV infection, cystic fibrosis, and vaccines, amongst others.
Dr Staffolani has 12 years experience in infectious diseases, vaccines and pediatric research and clinical trials, across all four phases both in hospital and outpatients, participating as both an investigator and Medical Advisor.
Board certified in pediatrics and infectious diseases, Dr. Staffolani pursued her medical degree at the University of Buenos Aires, Argentina. She completed her residency in pediatrics, and subsequently completed a fellowship in pediatric infectious diseases at Garrahan Hospital, Buenos Aires. Dr Staffolani is currently studying towards a Masters in Clinical Effectiveness at Buenos Aires University.
Mauro Martinelli, Emerging Markets Specialist, Quintiles
Mauro Martinelli has over 15 years working in the Clinical Research environment. As Regional Specialist for Emerging Markets since 2006, Mauro has been in charge of promoting Latin American participation in global studies by interacting with Global Account Directors, Medical Advisors and Therapeutic Specialists which has led to him becoming an advisor on Latin American issues to both internal and external customers.
Based in Washington DC since 2009, Mauro’s main focus has been on interacting with outsourcing and clinical departments of Pharmaceutical companies, providing general overviews on Latin America in relation to therapeutic experience, regulatory requirements and policies, patient profiles, as well as recommendations on country selection for specific clinical trials.
Experienced in sales, managing regional or global customers with specific interest in Latin America, Mauro has interacted with customers based in US, EU and Latin America.
Prior to this position, Mauro worked in the Quintiles Latin America Clinical Operations Department for over six years, based in Buenos Aires, Argentina, where he covered activities from monitoring to study management (Phase IIb, III and IIIb) across US, Latin America and Europe.
During 2004, he briefly relocated to Bogota, Colombia in order to set up the Quintiles Colombia office. Muaro holds a Biochemistry degree obtained from Universidad de Buenos Aires.
Who Should Attend?
- Vaccines clinical development programs-leaders and team members
- Vaccines R&D directors, managers in biotech or pharma
- Clinical program managers or project managers
- Patient recruitment specialists
- VP, Director of clinical operations
- Medical science liaisons
- Chief medical and scientific officers
- Regulatory affairs directors
Quintiles (NYSE: Q), a Fortune 500 company, is the world’s largest provider of bioPharmaceutical development and commercial outsourcing services. With a network of more than 29,000 employees conducting business in approximately 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.