Course Description

Phase I clinical trials aim to determine the safety, tolerability and pharmacokinetics (PK) of a compound. This web seminar will explore the challenges of developing Phase 1 clinical study protocols to ensure that the right patients are enrolled and that the right data are collected to demonstrate a drug is safe and efficacious, while at the same time managing study costs and complexity, especially in trials that involve early-phase drug metabolism, imaging and interventional procedures. Key factors to consider when developing protocols and techniques to minimize complexity while ensuring trial success will also be discussed.

Learning Objectives

• Understand the FDA requirements for Phase I clinical trials and review the different Phase I trial designs
• Discuss challenges with early phase studies for Sponsors, Contract Research Organizations (CROs), third-party vendors and sites
• Discuss how to optimize protocol design for a special population
• Identify risks in early phase clinical trials and mitigation strategies
• Address strategic planning and budgetary considerations for Phase I designs

Who Should Attend

• Clinical Operations and Clinical Research Associates
• Medical Affairs Specialists and Leaders
• Project Managers/Team Leaders
• New Clinical or other Project Team Leaders who will be managing projects
• Physician Investigators and Coordinators
• Regulatory Affairs Professionals
• Quality Assurance/Control (QA/QC) Professionals

Instructor

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

Registration Fees

$735*

*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-011-L99-P. Released: 1/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.