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Constructing the New Regulatory Framework for Complementary Medicines
With the package of reforms to the regulatory framework for complementary medicines in full swing, Complementary Medicines Australia’s (CMA) regulatory seminar offers delegates the chance to be on the front foot for positive change. CMA are excited to share with you the 2017 Regulatory Obligations Seminar Program offering a learning environment that will be educational and informative with an exceptional lineup of speakers and topics including:
Among the 19 recommendations to improve the regulation of complementary medicines, incentives for innovation, new listing pathways and a comprehensive and streamlined indications list are on the horizon for the sector. Be among the first to hear about the detail of the reforms, as well as the ongoing and future regulatory developments.
Program now available. Click the "Program" tab above for details.
Limited exhibition and advertising opportunities are available. Please contact Chelsea van Zyl for more information.
We look forward to receiving your registration and welcoming you to our Regulatory Obligations Seminar 2017.
8:30- 9:00
Registration& Exhibition
9.00- 9.15
Opening Address & Welcome
9.15-10.15
Reforms to the Regulation of Complementary Medicines
The TGA has commenced the implementation process of the Government’s response to the review of Complementary Medicines
Lyndall Soper
Assistant Secretary
Therapeutic Goods Administration
10.15 -11.00
Improving access to evidence based listed complementary medicines
New approval pathway for TGA ‘pre-market assessed’ listed medicines: the untapped opportunities
11:00 11:30
Morning Tea & Exhibition
11.30 -12.30
Permitted Indications for use in listed medicines
The levels of substantiation for scientific & traditional indications
Mechanisms for new indications
Dr Allison Jones
Director Listing Compliance
12:30 1:00
Australia Made: Country of Origin Labelling for Complementary Medicines
Implications of the recent passing of the Competition and Consumer Amendment (Country of Origin) Bill 2016.
Ian Harrison
Chief Executive Officer
Australia Made Campaign
1.00 2.00
Lunch break & Exhibition
2:00-
2.30
Low Risk Therapeutic Goods: To Regulate or Not to Regulate
Review of low risk therapeutic goods in a risk based regulatory regime.
How should low risk products be regulated? As a food or therapeutic?
Mark McDonald
Senior Adviser, Regulatory Reforms
2:30
3.15
Improving Competitiveness and Innovation in Complementary Medicines
Speaker Panel including industry perspectives
TGA speakers
Industry speakers
3:15
Afternoon Tea
3.30 4:45
The Science of Complementary Medicines Clinical Trials and CM Evidence Based Requirements
Clinical research contributes to improved health by providing new options for prevention and disease management that can be directly integrated into mainstream health practices. This session will cover the generation of robust evidence for the CM sector as well as potential challenges moving forward with regulatory reform.
Dr Jon Wardle
Head of Regulatory, Policy and Legislative Stream Australian Research Centre in Complementary and Integrative Medicine (ARCCIM)
A/Prof Dennis Chang National Institute of Complementary Medicine (NICM)
4:45- 5:00
Wrap up, thank you and close
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