Drug Safety Monitoring and Regulatory Reporting Requirements in Australia

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..

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

📍 This live online event is held via Zoom. Meeting link other information including templates, and case studies will be delivered via email upon registration and before class.

📃Certification: Each attendee who attends the session will receive a certificate of completion.

🎯 This masterclass is part of our award-winning Industry-Bridging Program (IBP), 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.

👩‍🎓 IBP trainees: Please use the discount code provided for registration.

✨ Group Discount: Enrol with 3 or more colleagues and save 30% on the total cost!