OUR COURSES

Course Directory

Our Courses

Know IVD: Understanding the IVD Market

Course Overview:
This course provides a foundational understanding of the In Vitro Diagnostics (IVD) market for those new to the sector or seeking deeper insights. It covers the role of IVDs in healthcare, key technologies, market dynamics, and regulatory considerations.

What You Will Learn:
• Introduction to IVDs and their importance in healthcare.
• Overview of the technologies used in diagnostic laboratories.
• Insights into the global and local IVD markets and customer bases.
• Basics of the regulatory landscape, including TGA.
• Key business models, sales cycles, and government involvement.

Who Should Attend?
Ideal for professionals in healthcare sales, product development, regulatory affairs, and those interested in understanding the IVD sector better.
TGA Regulations for IVDs: Introductory Course

Course Overview:
This course introduces participants to the regulatory framework governing In Vitro Diagnostics (IVDs) in Australia, focusing on the Therapeutic Goods Administration (TGA) requirements. It is ideal for professionals new to the IVD sector or those looking to enhance their compliance knowledge.

What You Will Learn:
• Core principles of TGA regulations for IVDs.
• Key definitions and terminology related to TGA compliance.
• Overview of the Australian Register of Therapeutic Goods (ARTG).
• Roles and responsibilities of sponsors and manufacturers.

Who Should Attend?
Suitable for professionals in regulatory affairs, quality assurance, and product development looking to build a strong foundation in TGA regulations for IVDs.
TGA Regulations for IVDs: Intermediate Course 
Course Overview

This course enables applicants to form a deeper understanding of the IVD regulatory framework and learn about more recent regulatory developments and requirements. It is designed for people who have a grounding in the IVD regulatory requirements in Australia. This is a full-day, face to face course.  

What You Will Learn: 
  • Conformity assessment
  • IVD classifications 
  • Application audits and ARTG changes 
  • Post market obligations 
  • Adverse event reporting 
  • Advertising code for IVDs  


Who Should Attend? 
Suitable for professionals in regulatory affairs and quality assurance. Recommended to complete TGA Regulations for IVDs: Introductory Course prior to enrolling in this course. 
TGA Regulations for IVDs: Advanced/Expert Course

Course Overview:  
This course provides a discussion forum for experienced regulatory affairs professionals to deep dive into topical and complex areas of the Australian IVD regulatory system. Facilitated by experts from the TGA and senior Regulatory Affairs representatives from PTA Technical and Regulatory Standing Committee (TARSC). This half-day course is held online  

What You Will Learn: 
  • Topic one: Digital products, IVD algorithms, CDSS, interpretive software – with and without AI, TGA’s expectations for documentation of safety, cybersecurity risk, and data privacy management 

  • Topic two: consistency of assessment, evaluation criteria, communication and responses between sponsors and TGA 


Who Should Attend? 
Suitable for Regulatory Professionals with deep experience in regulation of IVDs. This is an advanced-level course and should not be attempted without first completing TGA Regulations for IVDs: Introductory and Intermediate courses. 
ACCC Training: Navigating Anti-Competitive Conduct in Healthcare

Course Overview:This one-day, face-to-face training covers the essential aspects of ACCC regulations relevant to healthcare businesses. Participants will learn how to identify and prevent anti-competitive behaviour such as price-fixing, cartel conduct, and market manipulation. Through case studies and interactive exercises, the course provides practical tools to ensure compliance with ACCC laws.

What You Will Learn:• Key ACCC laws and how they apply to healthcare
.• Recognising and preventing price-fixing, collusion, and market manipulation.
• Practical case studies and hands-on exercises.

Who Should Attend?
Ideal for healthcare executives, compliance professionals, sales, procurement teams, and legal advisors looking to navigate ACCC regulations and maintain ethical business practices.



Director Training – Fiduciary and Legal Responsibilities 

Course Overview 
This full-day, face to face course is an interactive training session to learn about fiduciary and legal responsibilities, including real business examples and case studies for consideration. There is ample time for deep discussion, individual input, and personalised feedback.  

What You Will Learn: 
  • Understand the purpose, fiduciary, and statutory duties of executives. 
  • Identify questions executives should ask to familiarise themselves with their legal environment. 
  • Consider compliance cultures, frameworks, rights and protections for executives.  


Who Should Attend? 
If you’re contemplating completing the Australian Institute of Company Directors (AICD) or similar training, this course is for you.  Essential learning for anyone aspiring to a senior executive role or board position. 

Negotiation Top Tips

Course Overview  
This course offers a dynamic and interactive opportunity utilising role-play and practical sessions to learn techniques and strategies for successful negotiation. Successful negotiation skills enhance confidence to navigate any scenario.  

What You Will Learn
Negotiation structure Gaining influence Power dynamics Dealing with demands  

Who Should Attend? 
Whether you deal directly with customers or clients in Sales or Customer Service, or you work within a team or management structure communicating internally across your organisation. Negotiation skills can be universally applicable for any professional encounter, and this course is suitable for everyone.    

Wellbeing in the Workplace
Course Overview:
This course explores how to cultivate a culture of wellbeing within organisations, focusing on mental health, stress management, and building resilience. Ideal for managers and teams looking to improve workplace dynamics and support employee wellbeing.

What You Will Learn:
Key strategies for promoting mental and physical wellbeing in the workplace.
Techniques to manage stress and prevent burnout.
How to foster resilience and a positive workplace culture.

Who Should Attend?
This course is ideal for managers, HR professionals, and teams interested in creating a healthier, more productive work environment.
Influencing Government Decision-Making
Course Overview:
This course, led by government relations expert Georgie Smith, equips participants with the tools and strategies to effectively influence government policy and regulatory decisions within the healthcare and pathology technology sectors. Delivered online, it covers key aspects of the government policy cycle, building strategic relationships, and creating impactful advocacy campaigns.

What You Will Learn:
• Understanding government structures and decision-making processes.
• Crafting ethical and effective advocacy campaigns.
• Building and maintaining relationships with key stakeholders.
• Navigating regulatory frameworks and influencing policy outcomes.

Who Should Attend?
Ideal for healthcare executives, regulatory professionals, government relations specialists, and industry association representatives looking to engage with and influence government policy.
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