Fully Accredited Program Australia Clinical Trial TGA Regulations and GCP Compliance

Australia's clinical trial regulations are complex. The Therapeutic Goods Administration (TGA) has developed a rigorous set of over 200 specific guidelines that clinical trials must adhere to, underscoring the complexity of achieving regulatory compliance. Furthermore, more than 100 Human Research Ethics Committees (HRECs) actively participate in reviewing clinical trial protocols within Australia, ensuring that all research upholds the highest ethical principles.

This certified program is designed to provide you with an in-depth understanding of these complex regulations and help you navigate the challenges throughout the clinical trial process. You will gain expertise on a wide array of critical topics, including Australia’s Clinical Trial Regulation, TGA and Good Clinical Practice (GCP) compliance guidelines, Australian regulatory submission and approval process, CTN and CTA application and approval, subject protection and informed consent. You will also gain insights into the intricate requirements for documentation and safety reporting protocols, investigational product import & export as well as the impacts of non-compliance in clinical trials.

Furthermore, this program will equip you with practical skills to integrate these regulations into clinical trial design and management, ensuring compliance and ethical conduct throughout the trial process. This includes understanding the complexities of multi-state trials within Australia and adapting to evolving regulatory requirements. Additionally, you will also gain insights into effective data management and safety reporting techniques along with a robust safety management plan that mitigates potential safety concerns. By the end of the program, you will be adept in navigating the complexities of Australian clinical trial regulations, equipped with the strategies you need to mitigate risk and ensure compliance.

Upon successful completion of the program, you will attain the Certification in Australia Clinical Trial Regulations and Compliance. This distinguished certification will enhance your professional qualifications, demonstrating your proficiency in navigating the legal, ethical, and operational intricacies associated with the conduct of clinical trials. Globally demanded and recognized, the certification holds lifelong validity and will underscore your expertise and amplify your professional credentials in the vital area of clinical trial regulations.

4.6 (936 Professional Learners) 1

1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.

This program will entitle you:

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  • Experience 2 days of instructor-led live program and in-depth understanding of Australia’s legislation and regulations governing clinical trial practice, TGA and GCP along with comprehensive strategies for risk mitigation and compliance.
  • Attain the industry-recognized Certification in Australia Clinical Trial Regulations and Compliance. This certification will offer a testament to your expertise in conducting legally compliant clinical trials ensuring patient safety and confidentiality.
  • Gain insights from impactful case studies and best practices to effectively manage legal obligations, and implement efficient risk mitigation and compliance frameworks.
  • For inquiries, chat with our Program Advisors at [email protected] or call us at
    • USA: +1 888 745 8875
    • Singapore and Asia Pacific: +65 6716 9980
    • Australia and New Zealand: +61 3 9909 7310
    • UK, Europe and Middle East: +44 (020) 335 57898

Accreditations

4.8

This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.

The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.

What Can You Expect From This live Program

Australia's status as a prime location for clinical trials is highlighted by its conduct of over 1,000 trials annually, marking its significant contribution to global research and development. The nation's commitment is further demonstrated by its adherence to Good Clinical Practice (GCP) standards, with over 95% compliance. This strict observance not only safeguards participant safety, with serious adverse events occurring in less than 0.5% of cases, but also bolsters the integrity and international standing of its research findings. Mastery of Australia's regulatory landscape and stringent GCP guidelines is essential for navigating its complex clinical trial environment.

This certified program is designed to equip you with the essential knowledge and skills needed to effectively address the practical challenges of compliance in the clinical trial landscape. You will gain knowledge on a broad spectrum of critical topics, including an in-depth exploration of the Therapeutic Goods Administration (TGA) regulations, Good Clinical Practice (GCP) guidelines, ethical considerations, safety reporting, data management, and quality assurance. Participants will also gain a thorough understanding of the latest regulatory requirements and best practices in clinical trial compliance.

Throughout the program, you will delve into the intricacies of the TGA's Clinical Trial Notification (CTN) and Clinical Trial Exemption (CTX) schemes, gaining insights into the application process, documentation requirements, and timelines. You will also learn about the roles and responsibilities of key stakeholders, such as sponsors, investigators, Human Research Ethics Committees (HRECs), and institutional review boards (IRBs). Additionally, this program will cover the principles of GCP, including informed consent, participant safety, data integrity, and investigator responsibilities.

Throughout the program, participants will acquire practical skills in developing robust clinical trial protocols, managing essential documents, and implementing effective quality management systems. The program will also address the importance of pharmacovigilance and safety reporting, providing guidance on identifying, assessing, and reporting adverse events and serious adverse events. Furthermore, you will learn about data management and statistical considerations in clinical trials, ensuring the integrity and reliability of trial results.

Upon successfully completing the program, you will attain the highly respected Certification in Australia Clinical Trial Regulations and Compliance. This certification will serve as a testament to your expertise in navigating the complex landscape of clinical trial regulations and their commitment to upholding the highest standards of compliance. This industry-recognized certification will enhance participants' professional credentials and demonstrate their proficiency in designing, conducting, and managing clinical trials in accordance with TGA regulations and GCP guidelines.

Key Skills You Will Gain

  • Australia Clinical Regulatory Compliance
  • TGA Regulation
  • Good Clinical Practice Compliance
  • Clinical Trial Applications
  • Informed Consent
  • Clinical Trials Administration
  • Pharmacovigilance
  • Risk Assessment
  • Ethical Research
  • GDPR Compliance
  • Clinical Trial Auditing
  • Clinical Trial Design
  • Clinical Investigations
  • Safety Reporting
  • Clinical Trial Insurance
  • Clinical Quality Assurance (CQA)
  • Clinical Trial Reporting
  • AU Clinical Trials Legislation
  • Clinical Trials Authorization
  • Clinical Data Management
  • Clinical Trial Documentation
  • CTN/CTA application process
  • Auxiliary Medicinal Products (AxMPs)
  • Data Integrity
  • GCP Inspection

Your Faculty Director

Melinda Borrelli
Melinda Borrelli
Renowned Clinical Research and GCP Compliance Expert

Melinda Borrelli is a distinguished Clinical Research Professional with over 20 years of expertise in Australia's biotechnology industry. Her career encompasses a variety of roles that have cultivated a deep understanding of clinical research complexities, making her an expert mentor in the field.

Proficient in project management, Melinda has demonstrated her expertise through her proficiency in Electronic Data Capture (EDC), Good Clinical Practice (GCP), Clinical Trials, and CRO management. Now a certified vocational Trainer and Assessor, Melinda has transitioned to educating others, drawing on her extensive experience to guide peers through their professional development. She is a compelling presenter, known for engaging and enlightening audiences at both local and international conferences. Melinda Borrelli continues to be a catalyst for growth and excellence in the clinical research field, nurturing new talent and enhancing professional standards through her dynamic leadership and commitment to advancing clinical research practices.

Australia Clinical Trial TGA Regulations and GCP Compliance Program Agenda

Module 1 - Foundations of Clinical Trials: Introduction and Regulatory Evolution
Module 2 - Navigating TGA Regulations
Module 3 - Australian Clinical Trial Application and Approval Process
Module 4 - Understanding CTN/CTA: Acknowledgment vs Approval
Module 5 - Applying GCP Standards: Roles, Responsibilities, and Documentation
Module 6 - Ethical Foundations in Australian Clinical Research
Module 7 - Quality and Integrity in Clinical Trials
Module 8 - Clinical Trial Safety Management: Reporting, Planning, and Compliance
Module 9 - Ensuring Compliance through Effective Clinical Trial Monitoring
Module 10 - Navigating Complex Regulations

How You Will Benefit

  • Understand Australian Clinical Trial Regulations: Gain a deep understanding of Australia's Clinical Trial Regulation, including the Therapeutic Goods Administration (TGA) regulations and Good Clinical Practice (GCP) compliance guidelines.
  • Navigate Regulatory Submission and Approval: Learn the processes involved in Clinical Trial Notification (CTN) and Clinical Trial Approval (CTA) applications, including submission requirements and approval timelines.
  • Ensure Participant Safety and Informed Consent: Acquire knowledge on subject protection, informed consent processes, and the ethical considerations critical to participant safety.
  • Develop Effective Trial Protocols: Master the skills needed to design clinical trial protocols that meet regulatory requirements and address practical challenges of compliance.
  • Manage Documentation and Compliance: Understand the intricate documentation requirements essential for maintaining compliance with regulatory standards.
  • Implement Robust Safety Management Plans: Learn to develop and execute safety management plans that effectively mitigate potential safety concerns throughout the trial process.
  • Master Data Management and Safety Reporting: Gain insights into effective data management practices and comprehensive safety reporting protocols.
  • Adapt to Evolving Regulatory Landscapes: Equip yourself with strategies to adapt to changing regulatory requirements, particularly for multi-state trials within Australia.
  • Enhance Quality Assurance Practices: Acquire practical skills in implementing quality management systems that ensure data integrity and trial reliability.

Certification in Australia Clinical Trial Regulations and Compliance

Upon successfully attending this program, you will be awarded with the Certification in Australia Clinical Trial Regulations and Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.

Globally demanded and recognized, this certification will amplify your professional qualifications and demonstrate your expertise in navigating the intricacies involved in Australia’s clinical trials TGA regulations and GCP compliance. Developed by Chartered Institute of Professional Certifications, the content of this program has been independently accredited by CPD Certification Service as adhering to the highest standards of continuing professional principles.

Pricing & Registration

Please select one of the locations:

Australia

Dates: 4 - 5 Sep 2024

Venue: Online Executive Program (via Zoom)

Time: 10:00am - 5:30pm Australian Eastern Standard Time (AEST)


Early Bird Packages Regular Pricing
By 02 Jul 2024 By 13 Aug 2024 After 13 Aug 2024
Australia Delegates AUD 1,895 AUD 2,095 AUD 2,195

Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)

Register Now

Download Brochure

You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at [email protected] or call us at:

  • Singapore and Asia Pacific: +65 6716 9980
  • Australia and New Zealand: +61 3 9909 7310
  • UK, Europe and Middle East: +44 (020) 335 57898
  • USA: +1 888 745 8875

Download brochure Download Brochure

Australia Clinical Trial TGA Regulations and GCP Compliance Reviews and Testimonials

Attending the program was incredibly beneficial. The trainer's knowledge of TGA regulations and GCP compliance was extensive, and the course materials were well-organized and relevant to current clinical practices.
The sessions were informative and well-paced. The trainer's expertise in clinical trials was apparent, which enhanced the learning experience.
I appreciated the depth of information covered in the program. The trainer did an excellent job of breaking down complex regulations into understandable segments. It was a worthwhile investment of time.
Attending this program helped clarify many aspects of clinical trial regulations in Australia. The trainer was knowledgeable and presented the material in a concise manner. A good investment for professionals in the field.

Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.

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Securing approval from your boss to attend this program can be difficult if you don’t know what to say. So, we’ve prepared a template for you! All you need to do is to download this template, copy and paste in email and send it to your boss!

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Australia Clinical Trial TGA Regulations and GCP Compliance

4.6 (936 ratings)