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CMA Regulatory Seminar 2017

When
11 Apr 2017
8:30 AM - 5:00 PM
Location
InterContinental Hotel, Double Bay, Sydney

Registration

CMA Member – $548.90
Non-Member – $823.90

General Information
Program

Registration Closed

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:

Lyndall Soper, Assistant Secretary, Therapeutic Goods Administration presenting “Improving access to evidence based listed complementary medicines” and “Improving competitiveness and innovation in complementary medicines”.
Mark McDonald, Senior Adviser, Regulatory Reforms, Therapeutic Goods Administration presenting “Low Risk Therapeutic Goods: To Regulate or Not to Regulate”.
Dr Allison Jones, Director Listing Compliance, Therapeutic Goods Administration presenting “Permitted Indications for use in listed medicines”.
Ian Harrison, Chief Executive Officer, Australia Made Campaign presenting the “Country of Origin Labelling for Complementary Medicines”.

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.

DATE:	11/04/2017
TIME:	08:30 - 17:00
VENUE:	InterContinental Hotel, Double Bay, Sydney
PARKING:	Valet parking is available at the hotel for a flat rate of $50. Alternatively, you may also self-park at Wilsons Parking Double Bay whose entrance is right next to the hotel, or at Woollahra Council's car park at 1 Cross Street, a short 5 minute walk from the hotel.

Program

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	Lyndall Soper Assistant Secretary Therapeutic Goods Administration
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 Therapeutic Goods Administration
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 Therapeutic Goods Administration
2:30 3.15	Improving Competitiveness and Innovation in Complementary Medicines Incentivising innovation in the CM sector Mechanisms for regulatory protection Speaker Panel including industry perspectives	Lyndall Soper Assistant Secretary Therapeutic Goods Administration 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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