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Who should attend Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval: 2-Day Workshop
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
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Seminar Summary:

The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. (see full course description)

 
 
 

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Training Course Syllabus:


Australian Regulatory Guidelines for Medical Devices (ARGMD): Government Reimbursement, Requirements, Fees and Turnaround Time to Product Approval: 2-Day Workshop

Course Description:

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

Course Outline:

Day One (8:30 AM - 4:30 PM)

8:30 AM - 9:00 AM: Registration Process

9:00 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 Two (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

Seminar Summary:

The Australian regulatory and reimbursement agency have particular requirements in their assessments of applications for Medical Devices intended for supply in Australia. (see full course description)

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