San Francisco, California
London, United Kingdom
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.
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
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
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.