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Monthly Archives: November 2015

New Zealand Pharmacovigilance Guidelines Edition 2, effective in the New Year

In April this year, Medsafe released the new draft guidelines for pharmacovigilance (PV) in New Zealand. Interested parties were invited to provide comment and Medsafe provided feedback on these on their website. Part 8 of the Guideline of Therapeutic Products … Continue reading

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Your clinical study is only as good as your data

Clinical trials are intended to find answers to research questions by means of generating data for proving or disproving hypotheses. Clinical Data Management (CDM) is critical to the generation of high-quality, reliable, statistically sound data from clinical trials and thus … Continue reading

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Release for supply – What every sponsor should know

What is release for supply? Every batch of medicine sold or supplied in Australia is required to have undergone a “release for supply” procedure. This applies to registered medicines, listed medicines as well as investigational medicinal products (phase 2 or … Continue reading

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Pricing uncertainty within the Pharmaceutical Benefits Scheme

Recent years have seen an active attempt to control Pharmaceutical Benefits Scheme (PBS) costs. Price disclosure and mandatory price cuts upon formulary transition have ensured prices of pharmaceuticals (especially generics) continue to tumble. Yet despite the use of these tools, … Continue reading

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