Risk-Based Quality and Compliance Management in Combination Product Trials

Course Description

A risk-based approach to clinical trials requires not only a strategy, but tools to define key indicators to measure specific risks. As referenced in the most recent U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance documents, Key Risk Indicators (KRIs) and Critical to Quality (CTQ) metrics should focus on “what really matters,” and safety of research subjects and data integrity should be emphasized. Combination products can increase risks while being tested in clinical trials, therefore, these metrics should be linked to particular processes within a development program for combination products.

Learning Objectives

• Review the different types of combination products
• Review current regulatory updates and guidelines for combination products
• Discuss streamlined approach for combination products
• Describe principles of Quality by Design (QbD) and new regulatory requirements for risk-based monitoring and how it applies to trials with combination products
• Develop relevant metrics as quality and performance indicators for Risk-Based Quality Management (RBQM) systems for combination products
• Perform a cause-effect analysis for identified risks and develop mitigation strategies

Who Should Attend

• Clinical Quality Assurance Auditors
• Clinical Quality and Compliance Professionals
• Clinical Research Associates
• Project Managers
• Medical Monitors
• Regulatory Affairs Professionals
• Clinical Research Investigators and Coordinators

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 at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

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#: 0778-0000-22-031-L04-P. Released: 8/22. 

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