Launching complementary medicines in Australia requires a structured approach that integrates regulatory and quality requirements at every stage of the product development process. From feasibility to post-launch activities, each step is critical to ensure compliance with TGA standards and international guidelines, safeguarding product quality and consumer trust. This session will provide participants with an overview of the regulatory and quality requirements associated with product development, validation, execution, and postlaunch processes. Through practical insights, attendees will be equipped to streamline workflows and achieve market readiness effectively.
Learning objectives:
At the end of this session, attendees will:
1. Understand the regulatory and quality considerations at each stage of product development.
2. Gain insights into claims substantiation and product testing requirements.
3. Understand requirements for selecting manufacturers and GMP clearance.
4. Learn about post-launch activities, including change management, ongoing stability and pharmacovigilance.
Who should attend:
This session is tailored for:
• Regulatory affairs professionals.
• Quality assurance and control personnel.
• Product development teams in the complementary medicines industry.
• Sponsors and business owners navigating regulatory requirements.
• Graduates or industry newcomers seeking foundational knowledge of regulatory processes.
Whether you’re new to the industry or seeking to refine your approach, this session offers actionable insights to help you succeed in the competitive complementary medicines market.
Tina Bird: RegPartners | Director & Principal Consultant
With over 20 years of experience in the pharmaceutical industry, Tina has a proven track record in guiding businesses through the complexities of complementary and over-the-counter medicines. She has worked with leading companies such as Bristol- Myers Squibb, Catalent Pharma Solutions, and Blackmores Group, delivering strategic solutions to bring high-quality products to markets across Australia, New Zealand, Asia, and the USA. Tina’s expertise spans regulatory strategy, new product development, TGA compliance, GMP quality systems, and the development of customized training ã 2024 RegPartners 8 programs. Known for her practical and results-driven approach, she ensures businesses overcome regulatory and quality challenges efficiently and with confidence.
As the director of RegPartners, Tina is passionate about empowering health and wellness companies to achieve compliance and drive growth. Through her tailored support in regulatory affairs, quality management, advertising compliance, and training, she is committed to fostering collaboration, promoting industry best practices, and making a meaningful impact in the industry.