SME Assist Dr Tahli Fenner Director, Regulatory Guidance and SME - - PowerPoint PPT Presentation

2018 GMP Forum

SME Assist

Dr Tahli Fenner Director, Regulatory Guidance and SME Support Health Products Regulation Group Department of Health

26 June 2018

Background

• The review of Medicine and Medical Devices

Regulation (MMDR) highlighted that small and medium enterprises (SMEs) can find navigating the ‘regulatory maze’ a challenge.

• We need to make the regulation process easier

to understand, and to provide better support services for SMEs and companies in the innovative therapeutic goods industry.

• Consultations were undertaken in 2016

– Industry organisations – Government departments

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SME Assist

Launched Friday, 9 June 2017 at the Translational Research Institute, Brisbane by the Hon Greg Hunt, Minister for Health and Sport.

• Targets the needs of
• SMEs
• Those unfamiliar with therapeutic goods

regulation

• Informs therapeutic R&D groups
• Assists them to meet requirements for local

and international markets

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1) Guidance articles

Cover a range of introductory topics:

• Basics of regulation
• Market authorisation
• When to engage with the TGA
• Medical devices overview
• Useful resources (signposting to other services)

Written in plain English and targeted at beginners.

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2) Education and training

• Meeting Your Obligations workshops

– Five workshops held across Melbourne, Sydney and Brisbane – Supported by the Dept. of Industry’s Entrepreneurs’ Programme – Provided an overview of regulation, case study examples, Q&A with a panel of experts, and topic-specific breakout sessions – Targeted for those unfamiliar to therapeutic goods regulation

• Drop in days

– First one held in Sydney – Provides select SME’s with individual time with a TGA specialist – Provides better understand on how the regulatory framework impacts their product

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3) Interactive tools

• Decision trees to better understand the

regulation of specific products – Is my product a therapeutic good? – What classification is my device? – Which clinical trial scheme should I choose?

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4) Phone/email support

• To provide more tailored and efficient

assistance.

5) Subscription service

• Subscription service keeps you informed

about what’s coming up and new SME Assist services:

• Upcoming workshops and events
• New tools and online resources
• Webinars

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Coming soon

• Meeting your obligations workshops will be held in

Sydney, Melbourne, Brisbane, Perth and Adelaide over the next financial year

• New guidance material including Introduction to

ingredients and Resources for Researchers

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As of 30 June 2018:

45,013 visitors to the SME Assist web page 567

Subscribers to SME Assist emails

6,798

uses of interactive decision tools

>230

phone and email enquiries answered

226

attendees at Meeting Your Obligations workshops

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