Yearly Archives: 2017
New ‘SmPC’ Format for the Australian Product Information
The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients. The new form will be implemented over a … Continue reading
Commercial Eyes Recruiting: Pharmacovigilance / Drug Safety Professional
Commercial Eyes has fabulous new projects coming on line so we are looking for the right people to join our Pharmacovigilance Team. Working in Commercial Eyes, a leading pharmaceutical consultancy, will give you a breadth of experience across medicines (pharma, … Continue reading
Transition to eCTD is gaining momentum in Australia
At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading
