ComplianceOnline

Course "Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. A well-defined approach or a clearly set up manual is nonexistent but the expectations are clear, if the application has errors or a document is not conclusive than the assessment of the associated application is delayed or worse still, the complete submission may just be rejected. You may then need to start again and potentially lose your fees.

In this two-day workshop conference, you will learn the complete pathway. You will be shown what and when to submit information, particular requirements, expectations from the agencies and the determination of a forecast launch date for your products. Through case study analysis, we will examine best practices to minimize errors in order to achieve product approvals.

Learning Objectives:

Upon completing this course participants should:

  • Understand keys areas of the legislative instrument dictating regulatory requirements
  • Easily navigate pertinent website for specific documents for the application to the authorities
  • Explore the Regulatory and Reimbursement landscape, for presentation of the competitive and product comparator market to your sales and marketing team
  • Understand your accountability as an Applicant, Sponsor and Manufacturer for products supplied in Australia
  • Understand the complete submission application pathway for products with all risk classifications
  • Assess and critique documentation intended to be submitted
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Who will Benefit:

This course is designed for people tasked with submitting applications to the Regulatory or the Reimbursement Government Authority for Medical Devices (Exclusion are IVD products).

Personnel in the following areas will benefit from the course:

  • Personnel involved in start-up or in well-established global companies with intentions to market their products in Australia
  • Regulatory professionals
  • Compliance professionals
  • Personnel involved in Research and Development
  • Marketing professionals
  • Document control specialists
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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Day 1 -Lectures and Workshop Exercises
  • Module 1: Medical Devices 101 – An introduction
    • The Regulatory and the Health Economist – The Strategist or an Administrator
    • How do I confirm that my product is regulated as a Medical Device – What if decision tree
    • The assessment of the Regulatory landscape_ Who’s who in Australia -Search options
    • Responsibilities as the applicant and accountability of the sponsor and manufacturer
    • Elements of a contractual agreement between all parties -
    • Available alternative options of supply
  • Module 2: Legislative imperatives in the submission process
    • Therapeutic Goods Act
      • Significance of particular clauses
    • Therapeutic Goods Regulations
      • Significance of particular clauses
  • Let’s talk about Brexit and Regulatory implication with Europe and Australia

    The Technical file and compilation
    Key elements for inclusion – Marriage of MED/2.5.1/Rec5, GHTF STED, IMDRF/RPS WG/N9, TGA’s supporting Data form

  • Module 3
    • The intended purpose of your product and claims
    • The Australian Essential Principles Checklist
    • Comparatives to the EU Essential Requirements Checklist
      • The Australian Classification Rule
    • Comparatives to the EU Classification Rule
  • Module 4: Quality Management System 101- ISO 13485
    • Let’s talk about document management and control
      • Excel 101, power of use and the beauty of hyperlinks
    • Risk assessment 101 - ISO14971
    • When does risk assessment stop
    • Clinical product Assessment
      • Differences between Meddev 2.7/1 rev 4 and Australian proposed clinical evidence guideline
      • Comparatives of Australian guidelines to MEDDEV 2.7/1 revision 4
    • Labels and requirements
Day 02(8:30 AM - 4:30 PM)
  • Day 2 -Lectures and Workshop Exercises
  • Module 5: TGA application Process
    • Application type and Conformity Assessment approach
    • The Australian Declaration of Conformity and significance and relationship with a well set up contractual agreement.
    • The GMDN code, its significance and cost implications
    • Fees, timelines and assessment turnaround time to approval
    • Particular requirements from your manufacturer in the submission process
  • Module 6: The Australian Healthcare System and Government reimbursement of implantable products
    • Does your product qualify for reimbursement
    • The Prosthesis List Management System
    • Imperatives in the application process
    • Fees, timelines and assessment turnaround time to approval
  • Module 7: Post market accountabilities
    • Adverse Reactions – Global vs locals reporting
    • Recalls and related responsibilities
    • IRIS
    • Post market complaints reporting and the essentials of a common Standard Operating Procedure for Reporting
  • Module 8
    • Workshop and case study
    • Review of inputs into the technical file
    • Documentation management system in place
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George Azoury

George Azoury
Chief Executive Officer,RQSolutions Pty Ltd

George Azoury is principal and founder of RQSolutions. A leading consulting company located in Sydney, Australia, servicing the Medical Device Industry since 2002. Previous to this, George has held various local and regional positions in Regulatory, Compliance and Health Economics in a number of national and multinational companies. George is well known at both a local and global level with involvements with a number of companies ranging from the start-ups to the well-established manufacturing facilities in Europe, US and the Asia Pacific region.

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$1,099.00

Seminar One Registration (USD)

December 8-9, 2016, Sydney, Australia

$5,099.00
$6,594.00 (22%)*

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December 8-9, 2016, Sydney, Australia
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Your registration fee includes the workshop, all course materials and lunch.


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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Location

Radisson Hotel & Suites Sydney
72 Liverpool Street,
Sydney NSW, Australia, 2000
Tel:+61 2 8268 8888

December 8-9, 2016

How to Reach

General Driving Directions:

Driving directions from Sydney Airport (SYD) - 12.1 km:
  • Get on M1 from Joyce Dr and General Holmes Dr (1.7 km).
  • Follow M1 to Eastern Distributor in Darlinghurst. Exit from M1 (8.1 km).
  • Take Cross City Tunnel and Bathurst St to Liverpool St in Sydney.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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If you wish to partner with us for this event please contact us: partner@complianceonline.com or call us: +1-888-717-2436.

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Gold Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
  • Logo on name cards
  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
Bronze Partner
  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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