Drug Development Latin America

Miami, Florida (March 09-10, 2008)

Pharmaceutical and biotechnology companies are seeing rapid growth in the volume of their research, development, and clinical trials activity in Latin America. At the same time, this region presents unique challenges that must be anticipated and managed.

Join us for two days of interactive presentations and discussion on the following topics:

* Latin America vs. other emerging markets in clinical research   * Drug regulatory harmonization efforts led by PAHO   * Designing and planning trials in Brazil, Mexico, Argentina and other countries   * Identifying and developing appropriate investigators and research centers in Latin America   * Challenges and opportunities of expansion of clinical research into private hospitals and hospitals outside the large metropolitan centers   * Participation of academic institutions as Centers of Excellence in drug development research   * Feasibility and the site selection challenge: Do we need a different approach for Latin America?   * Managing the ethical review committee process   * Utilizing and integrating local clinical data to mutually support global and regional applications   * Managing logistics and shipping of investigational medical product (IMP) and lab supplies to support trials   * Review of key logistic suppliers in Latin American region (drug storage depots, centralized and per country clinical lab solutions)   * Optimizing patient recruitment and retention strategies in the region   * Adaptive protocol designs (Phase I-III) and regulatory challenges   * Experimental medicine, exploratory pharmacogenomics research, and Phase I studies in Latin America   * Status of IP protection in the Latin America region   * Meeting CMC Dossier Content expectations without sacrificing intellectual property

More: http://www.healthtech.com/lam/overview.aspx?c=6606