Post-Symposium Workshop:

Optimizing GCP Compliance: Shifting from Disaster Recovery to Disaster Prevention

Rockville, MD, June 17, 2009

• Link to workshop announcement
  • A workshop for experienced clinical investigators, clinical staff and sponsor representatives who have a working knowledge of VICH GL9
    • Drug development for FDA approval is an evidence-based discipline that has become increasingly challenging and complex. As new therapeutic targets emerge in veterinary medicine, drug sponsors
      and investigators are under increased pressure to ensure data integrity in more multifaceted study designs and clinical settings. The costs of noncompliance can be devastating as measured by lost time to market, reinvestment/recovery costs, and ultimately one’s reputation. This interactive workshop will cover common challenges of compliance with the regulations and understanding the role of guidance document VICH GL9 GCP in the conduct of pivotal field studies to meet FDA’s substantial evidence of effectiveness criteria.
  • Agenda and faculty descriptions
    • Case scenario examples of poor planning, conflicts in facility operations and personnel, case report form design and implementation, and raw data recording issues (including a "raw data worksheet" exercise) will be provided. GCP compliance challenges will be discussed with audience interaction, including perspectives from the FDA compliance officer, study site and sponsor perspective. The workshop will address why studies fail due to compliance issues and what measures are necessary in planning to prevent compliance failures, with an emphasis on providing helpful hints.
• Cost will be $400 for industry representatives and $200 for academicians and veterinary practitioners
• Register for this Workshop using the registration form for the 16th Biennial

Hotel Information:

Link to Hilton Washington DC/Rockville Hotel & Executive Meeting Center