Ensuring Drug Accountability in Clinical Trials

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Description

In clinical trials, drug accountability is crucial for ensuring participant safety, maintaining data integrity, and complying with regulatory standards. Proper management of investigational products (IPs) involves meticulous tracking of their receipt, storage, dispensing, and disposal. Regulatory agencies, including the TGA (Australia) and FDA (USA), emphasise the importance of accurate drug accountability records, as deficiencies can lead to significant compliance issues.

This 2-hour interactive masterclass offers a comprehensive guide to implementing robust drug accountability practices, ensuring your clinical trials adhere to Good Clinical Practice (GCP) guidelines and withstand regulatory scrutiny.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBPTM), which bridges the experience gap by equipping you with the essential job skills, industry knowledge, and real-world experience needed to successfully break into the clinical research industry.

Key Benefits

• Ensure Compliance: Align your drug accountability practices with global regulatory standards to avoid common compliance issues.
• Protect Data Integrity: Maintain accurate records to ensure the reliability of trial results.
• Enhance Participant Safety: Implement procedures that ensure participants receive the correct IP dosages.
• Improve Audit Outcomes: Be prepared for inspections with comprehensive and accurate drug accountability documentation.
• Gain Practical Insights: Learn from real-world scenarios to apply best practices in your trials.

What You’ll Learn:

• Regulatory Requirements: Understand the specific drug accountability obligations under ICH-GCP and TGA and FDA regulations.
• Comprehensive Record-Keeping: Learn to maintain detailed records of IP receipt, storage conditions, dispensing logs, returns, and disposal methods.
• Risk Mitigation Strategies: Identify common pitfalls in drug management and develop strategies to prevent non-compliance.
• Inventory Management: Master techniques for accurate tracking and reconciliation of IP inventory throughout the trial lifecycle.
• Audit Preparedness: Prepare for regulatory inspections by ensuring your drug accountability processes are thorough and transparent.

Who Should Attend?

• Aspiring / Clinical Research Associates (CRAs): Enhance your oversight of site-level drug management.
• Clinical Trial Coordinators (CTCs): Implement effective drug accountability procedures at trial sites.
• Pharmacists and Pharmacy Technicians: Ensure proper handling and documentation of investigational products.
• Regulatory Affairs Professionals: Align drug accountability practices with current regulatory expectations.
• Quality Assurance Personnel: Monitor and audit drug management processes to uphold trial integrity.
• University Graduates & Career Changers in Clinical Research
• Anyone looking to strengthen their industry skills

Format, Date and Time

This is a paid online event. Current Clueo Clinical IBP^TM trainees: please follow the instructions provided during your onboarding.

Attendees will receive access link and password before the event.