Many drugs that have safe and effective medical uses in clinical trials can also carry a potential risk for abuse. The United States Drug Enforcement Administration (DEA) has grouped these drugs into schedules, ranking them by their potential for abuse, from highest to lowest. This conference explores the steps necessary to comply with DEA and state regulations. It also focuses on the regulations surrounding use, distribution and control of Schedule II narcotics in a clinical trial, as well as the roles and responsibilities of the sites, monitors, managers and sponsors.

This audio conference covers:

• Different state regulations regarding Schedule II drug narcotics
• Extra steps needed to ship drug to a study site complying with DEA regulations
• Understanding the definition of scheduled drugs and levels of control
• Steps to take when there is missing study drug at a site when conducting a study with a Schedule II

About the speakers:

Michelle D'Ovidio is a Project Manager at Covance Periapproval Services. Her clinical research experience spans 10 years. She is responsible for the successful management of clinical projects, as well as supervising the clinical staff assigned to the projects. Her additional responsibilities include study plan development, employee performance reviews, as well as career development plans.

Ms. D’Ovidio has therapeutic expertise within the areas of musculo-skeletal (osteoarthritis, pain-acute, pain-chronic, vertebral fractures), respiratory (asthma, COPD), neurology/psychiatric (diabetic neuropathy, schizophrenia), hematology (deep vein thrombosis/pulmonary embolism), immunology (rheumatoid arthritis, vaccine), and infectious disease (pneumonia-community acquired, sepsis).

Vanesa Castillo is a Project Director within the Clinical Operations Department at Covance Periapproval Services. In this role, she serves as operational leader for domestic and international projects. She is responsible for supervising and monitoring the workload of project managers to meet agreed upon timelines and budgets, and ensuring that all direct reports adhere to the professional standards and SOPs established for clinical research.

Ms. Castillo has a wide range of research and management experience in the CRO and pharmaceutical industries. She began her career monitoring clinical trials in Buenos Aires, Argentina. She was a member and founder of the Argentine Association of Clinical Research. Ms. Castillo has accumulated extensive experience in the management and direction of clinical trials in several therapeutic areas including oncology (chemotherapy induced asthma), genitourinary (anemia in chronic renal failure), dermatology (psoriasis, atopic dermatitis), musculoskeletal (psoriatic arthritis), mental disorders (schizophrenia), infections/parasitic disease (RSV, pertussis), CNS (pain management), and immunology (renal transplant).

Who should attend?

• All Levels of Managers
• Project Directors
• Project Managers
• Vice Presidents

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.