Drug Safety Monitoring and Regulatory Reporting Requirements in Australia

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Description

Are you an aspiring or early-career clinical research professional wanting to enhance your industry skills to enhance your CV and job-readiness? In the dynamic clinical trial industry, ensuring patient safety is paramount, particularly within Australia’s stringent regulatory framework.

This 2-hour interactive masterclass offers an in-depth exploration of Drug Safety Monitoring and Regulatory Reporting Requirements in Australia, providing practical strategies to tackle real-world challenges head-on. Equip yourself with the knowledge and skills to navigate the complex landscape of pharmacovigilance effectively, improve compliance, and uphold the highest standards of clinical research.

🎯 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

• Regulatory Compliance: Align your practices with Australian regulatory requirements to ensure compliance and avoid potential legal issues.
• Enhanced Safety Monitoring: Implement robust safety monitoring processes to protect trial participants and ensure data integrity.
• Effective Reporting: Master the procedures for timely and accurate adverse event reporting, contributing to the overall safety profile of investigational products.
• Risk Mitigation: Develop and apply risk management strategies to proactively identify and address potential safety concerns during clinical trials.
• Professional Development: Enhance your expertise in pharmacovigilance, boosting your CV and increasing your job readiness in the competitive field of clinical research.

What You’ll Learn:

• Australian Regulatory Framework: Gain a comprehensive understanding of the Therapeutic Goods Administration’s (TGA) pharmacovigilance responsibilities for medicine sponsors, including mandatory reporting requirements and best practices.
• Safety Monitoring in Clinical Trials: Learn the procedures and requirements related to safety data collection, verification, and reporting in clinical trials, as outlined by the National Health and Medical Research Council (NHMRC).
• Adverse Event Reporting: Understand the importance of reporting adverse drug reactions (ADRs) and how such reports contribute to medicine and vaccine safety in Australia.
• Risk Management Strategies: Develop effective risk management plans to identify, assess, and mitigate potential safety issues during clinical trials.
• Compliance with Good Clinical Practice (GCP): Ensure adherence to GCP guidelines for safety monitoring and reporting, maintaining the highest ethical and scientific standards in clinical research.

Who Should Attend?

• Aspiring Clinical Research Associates (CRAs)
• Clinical Trial Assistants (CTAs)
• Research Nurses & Study Coordinators
• University Graduates & Career Changers in Clinical Research
• Anyone looking to strengthen their industry communication 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.