The Australia Therapeutic Goods Administration (TGA) regulations are among the most rigorous in the world, with over 1,000 pages of legislation, regulations, and guidelines detailing strict requirements for therapeutic goods and clinical trials. Navigating this complex regulatory framework is crucial, as the TGA enforces stringent compliance standards, with over 2,500 enforcement actions taken in 2023 alone for non-compliance.
This certified training program will provide you with an in-depth understanding of the Australia’s TGA regulations, offering practical insights to help you achieve and maintain full compliance for your therapeutic products as well as clinical trials and research compliance. Throughout this program, you will gain a comprehensive grasp of the legal requirements, recent changes in the regulatory landscape, and best practices for compliance within the Australian market. You will explore critical aspects of TGA regulations, including clinical evidence requirements, advertising rules, import/export protocols, and post-market surveillance obligations.
Specifically, you will learn how to comply with safety and quality standards, understand pharmacovigilance responsibilities, and manage ongoing post-market monitoring. This program will also cover the challenges of meeting clinical evidence requirements, mastering the intricacies of medical device classification, and understanding the regulatory pathway for complementary and alternative medicines within the TGA framework.
With a focus on developing expertise, we will explore key compliance areas such as clinical trial authorization, adverse event reporting, regulatory submission and audit/inspection readiness. You will acquire the skills to interpret TGA regulations accurately, develop compliant documentation, and create effective systems for ongoing compliance management. By attaining deep knowledge in this intricate regulatory environment, you will be equipped to avoid costly compliance pitfalls, product recalls, and enforcement actions.
Upon successful completion of the program, you will be awarded the Certification in Australia Therapeutic Goods Administration (TGA) Regulations and Compliance. This distinguished certification will enhance your professional qualifications, demonstrating your proficiency in developing and implementing effective compliance strategies associated with the TGA regulations. In addition, this industry-recognized certification holds lifelong validity and will offer a testament to your expertise and commitment to excellence as a knowledgeable leader in regulatory affairs and compliance within the Australian healthcare sector.
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:
Download Brochure Pricing & Registration- Gain in-depth knowledge of Australia's Therapeutic Goods Administration (TGA) regulations, including legal requirements, recent updates, and compliance best practices.
- Acquire valuable skills in regulatory strategy development, including product classification approaches, market authorization pathways, and international regulatory harmonization.
- Develop expertise in clinical trial authorization, pharmacovigilance, and post-market surveillance to ensure ongoing regulatory compliance.
- Attain the industry-recognized Certification in Australia Therapeutic Goods Administration (TGA) Regulations and Compliance. This certification will serve as a testament to your expertise in TGA regulations, GMP compliance, clinical trial regulations, and pharmacovigilance requirements.
- For inquiries, chat with our Program Advisers at advisor@charteredcertifications.com 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
Accreditations
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 leadingindependent 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 TGA regulations encompass a broad range of products, from pharmaceuticals to medical devices and complementary medicines. The complexity of these regulations leads to lengthy and intricate compliance processes. For instance, compliance with the TGA's medical device regulations requires meeting around 50 different standards, creating a complex regulatory environment that over 60% of small to medium-sized enterprises find difficult to navigate.
This certified training program will provide you with an in-depth, technically robust understanding of Australia’s TGA regulations, equipping you with the critical knowledge and practical tools necessary to achieve and sustain full regulatory compliance for therapeutic products, clinical trials, and research activities. Designed for professional leaders navigating Australia’s complex pharmaceutical, biotechnology, and medical device landscape, this program provides a structured approach to mastering the intricate requirements set by the TGA. You will gain a detailed understanding of critical compliance areas, including Good Manufacturing Practice (GMP) requirements, product registration pathways, clinical evidence standards, pharmacovigilance obligations, and regulatory reporting mechanisms.
Throughout the program, you will also explore the complexities of TGA approvals, including pre-market assessment, regulatory submissions, and conformity assessment requirements for medical devices, prescription medicines, biologics, and complementary and alternative therapies. You will develop the skills to classify therapeutic goods correctly, interpret regulatory expectations for clinical trial authorization, and ensure compliance with stringent safety, quality, and efficacy standards. This program will also cover critical post-market surveillance obligations, including adverse event monitoring, real-world evidence collection, and regulatory audits, ensuring you remain aligned with evolving TGA enforcement priorities.
Upon successful completion of the program, you will attain the Certification in Australia Therapeutic Goods Administration (TGA) Regulations and Compliance, enhancing your professional credentials and demonstrating your expertise in navigating TGA challenges, ensuring compliance, reducing risks, and strengthening your organization's regulatory strategy for safe and effective healthcare products. Globally demanded and recognized, the certification holds lifelong validity and will underscore your expertise and amplify your professional credentials in the vital area of medical and healthcare regulations.
Key Skills You Will Gain
- TGA Regulatory Compliance
- ARTG Registration
- GMP and GCP Implementation
- Therapeutic Goods Act 1989
- Pharmacovigilance and Risk Management
- Medical Device Classification
- Regulatory Audit
- Regulatory Pathway Selection
- Inspection Preparedness
- Good Clinical Practice (GCP) Compliance
- Adverse Event Reporting
- Post-Market Surveillance
- TGA Regulatory Framework
- Product Life-Cycle Management
- Regulatory Submission Preparation
- Common Technical Document (CTD) Dossiers
- TGA Clinical Trial Notification (CTN)
- Clinical Trial Exemption (CTX) Schemes
- GMP Inspection
- Recall Management
- Orphan Drug Designation
- Biologicals & In Vitro Diagnostics (IVDs) Compliance
- Risk Management Plans (RMPs)
- Periodic Safety Update Reports (PSURs)
- Compliance Documentation & Reporting
- TGA Audits
- Post-Approval Variations
- Product Recalls
- TGA Risk-Based Approach
Your Faculty Director
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 Therapeutic Goods Administration (TGA) Regulations and Compliance Program Agenda
How You Will Benefit
- Master TGA Regulatory Framework: Gain a comprehensive understanding of Australia’s Therapeutic Goods Administration (TGA) regulations, covering legal requirements, compliance best practices, and regulatory updates.
- Navigate Clinical Evidence Requirements: Learn how to meet the TGA’s stringent clinical evidence standards for therapeutic products, ensuring regulatory approval and compliance.
- Ensure Compliance with Safety and Quality Standards: Develop expertise in adhering to TGA-mandated safety, quality, and efficacy requirements for pharmaceuticals, medical devices, and biologics.
- Manage Post-Market Surveillance: Understand post-market obligations, including adverse event monitoring, real-world evidence collection, and regulatory audits, to maintain ongoing compliance.
- Interpret and Apply Good Manufacturing Practices (GMP): Gain in-depth knowledge of GMP requirements for therapeutic product manufacturing, ensuring compliance with TGA regulations.
- Streamline Regulatory Submissions: Develop the skills to prepare and submit comprehensive regulatory dossiers for TGA approval, including pre-market assessments and conformity evaluations.
- Strengthen Pharmacovigilance Capabilities: Understand the critical responsibilities of pharmacovigilance, including risk management, adverse event reporting, and safety monitoring.
- Achieve Clinical Trial Compliance: Learn how to navigate clinical trial authorization, meet regulatory expectations, and ensure compliance with TGA guidelines.
- Enhance Audit and Inspection Readiness: Gain practical strategies for preparing regulatory documentation, maintaining compliance systems, and successfully handling TGA audits and inspections.
Certification in Australia Therapeutic Goods Administration (TGA) Regulations and Compliance
Upon successfully attending this program, you will be awarded with the Certification in Australia Therapeutic Goods Administration (TGA) 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 demonstrates your expertise in navigating Australia's TGA regulations, enabling you to develop effective compliance strategies, manage regulatory risks, and ensure the safety and efficacy of therapeutic goods in the Australian market. By earning this certification, you will be recognized as a subject matter expert in TGA regulations compliance and will be well-equipped to take on leadership roles in regulatory affairs, quality assurance, and compliance management. This program is developed by Chartered Institute of Professional Certifications and the content of this program has been certified by CPD Certification Service as conforming to continuing professional principals.
Pricing & Registration
Australia
Dates: 4 - 5 Aug 2025
Venue: Online Executive Program (via Zoom)
Time: 10:00am - 5:30pm Australian Eastern Standard Time (AEST)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 30 May 2025 | By 11 Jul 2025 | After 11 Jul 2025 | |
| 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 NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at advisor@charteredcertifications.com 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
Australia Therapeutic Goods Administration (TGA) Regulations and Compliance Reviews and Testimonials
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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Australia Therapeutic Goods Administration (TGA) Regulations and Compliance
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