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What is Happening with the Provisional Approval Pathway?

Latest News,

Extension to TGA Transition Periods for Reclassified Devices and Patient-Matched Devices

The Therapeutic Goods Administration (TGA) recently announced that they have received Government approval to extend the transition period affecting most reclassified devices, as well as patient-matched devices, extending the deadline…

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Commercial Eyes Appoints New General Manager

We are excited to announce Tanya van der Wall as our new General Manager. With her extensive experience and deep understanding of the industry, Tanya will lead our expert team…

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Events & Webinars,

World Health Day 2023

On World Health Day 2023, the Commercial Eyes team reflects on the importance of accessing healthcare and how available and supportive wellbeing programs can positively impact our…

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Understanding Patient Perspectives: The First in our Ongoing Patient Survey Series

In recent years there has been a shift in healthcare towards a more ‘patient-centric’ approach. However despite this shift, there remains a limited understanding of patients’ perspectives. Here we present…

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Supporting Our Support Workers

Social workers provide vital support in the healthcare cycle, helping with treatment plans and being a critical communicative link between patients and HCPs. This link can be used to help…

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Developments in Thought-Leadership

Identifying the right thought leader is critical in Medical Communications, and with the shift to omnichannel marketing, these leaders are finding new mediums to engage and influence scientific…

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International Women’s Day 2023

Commercial Eyes was built on the foundation of a flexible business model designed to embrace and empower the incredible women in our…

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Significant TGA Fee Increases for Medical Devices in FY24

The Therapeutic Goods Administration (TGA) have released its consultation paper on the proposed fees & charges model for the 2023-24 Financial…

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Events & Webinars,

Commercial Eyes focuses on Rare Disease Day 2023

On Rare Disease Day 2023, the Commercial Eyes team stands with the rare disease community and recognise their strength and resilience. We encourage all stakeholders to work together to support…

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Events & Webinars,

2023 Kosi Challenge with Rare Cancers Australia

Commercial Eyes to join Rare Cancers Australia in our first Kosi Challenge. The work we do every day with clients and stakeholders confirms how devastating cancer is to the Australian community….

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Pricing & policy decisions: Do you have an external or company only view?

The effectiveness of one intervention compared to another, also known as the treatment effect, is frequently a key consideration when assessing the cost-effectiveness of alternative therapeutic interventions for economic…

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A high-quality Medical Information service is an investment in patients and the healthcare system, not a commodity.

Despite being readily accessible to patients and health care professionals, Medical Information remains an underutilised resource….

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Facing Challenges in Medical Information

We really do pride ourselves on efficiency and quality. We aim to respond and provide quality information in a timely manner, as we understand the urgency of these enquiries and…

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Extended hours for Medical Information Service

The need for Medical Information services outside the standard 9am to 5pm AEST business day has become increasingly important and is required by sponsors nationally and globally. With having extended…

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Navigating Significant Safety Issues

In recent years public expectations for rapid identification and the prompt management of emerging safety issues has grown exponentially, with drug safety coming to the forefront of many consumers’…

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Using Overseas Approvals for Medical Devices to Enter the Australian Market

In May 2017, the TGA issued a public consultation to seek feedback on the proposed use of marketing approval by comparable overseas regulators for devices manufactured overseas, to support inclusion…

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Navigating challenges throughout the lifecycle maintenance process can be complex.

A regulatory agency expectation for the sponsor following the registration of a therapeutic good in Australia or New Zealand is keeping the licence up to date. This is undertaken through…

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Easing the GMP Clearance burden

Prior to submitting a new medicine for registration or listing, TGA require the sponsor to have already submitted GMP Clearance applications for overseas sites involved in the manufacture of the…

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Navigating the Complexities of Medicine Registration

For a sponsor considering entering the prescription medicine space, it is important to evaluate all the regulatory pathways possible….

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