This free breakfast seminar is appropriate for executives, regulatory representatives, biostasticians, clinical operations directors, and other strategic decision makers in the pharmaceutical and biotech industry.

Micaela Salgado-Gomez, senior manager, clinical programming biostatistics for Synteract, and Spencer Hudson, vice president of biometrics, InterMune, Inc. will be featured speakers for the CDISC session. In addition to a general overview of CDISC and what it means to the industry, the forum will include discussions of CDER (Center for Drug Evaluation and Research) requirements, the benefits of conforming early to submission standards, CDISC potential, and the "do's and don'ts" of vendor selection.

Dr. Edgar Fenzl, managing director of FGK Clinical Research, GmbH, is the highlighted speaker for the session on Legal Representation in the EU. Dr. Fenzl's presentation will include an overview of legal representation in the EU, the EU's requirements for having a sponsor legal representative, as well as what to expect during an inspection in the European Union.