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Category Archives: Life Sciences Industry

Relating to the Life Sciences Industry in general

What is food for special medical purposes (FSMP)?

With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can … Continue reading

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Stressed? Well your products should be!

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading

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Proposed updates to GVP Module VI and what this might mean for our clients

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … Continue reading

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Medicine labels: TGO 91 and TGO 92. What’s the impact?

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading

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Patient support program – the key driver of better health outcomes

Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices. They provide significant value to patients through the accessibility of information and support. … Continue reading

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Commercial Eyes Recruiting: Senior Market Access Consultant

Commercial Eyes has a great opportunity for a Senior Market Access consultant to join our dynamic Market Access team. Reporting to the Health Economics and Market Access Manager, this senior consulting role offers the successful candidate the opportunity to gain … Continue reading

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Warning: This medical device literature review may contain traces of LBS

With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in … Continue reading

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Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market

As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding … Continue reading

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Data and Safety Monitoring of Clinical Trials

Randomised clinical trials for medicines and medical devices are progressively being monitored for safety and other interim results by both Sponsors and Contract Research Organisations (CROs). There are a variety of methods to aid in proactive monitoring and gauging of … Continue reading

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Are you eCTD ready?

eCTD in Australia Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an … Continue reading

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