Monthly Archives: February 2016
Dr Greg Pearce – Time to support biosimilars
Dr Greg Pearce, from our Regulatory Services team, has written a follow-up article for Pharma in Focus on biosimilars. Dr Pearce’s first article focussed on the challenges biosimilars pose for the Australian medicines industry. This second article looks at the … Continue reading
Using an overseas reference product in your bioequivalence studies
It is the TGA’s preference that bioequivalence (BE) studies to support generic medicines are performed using the Australian (AU) innovator product as the reference; however, within certain TGA conditions, it is possible to use an overseas reference/innovator product in your … Continue reading
Commercial Eyes welcomes Clare Price
Commercial Eyes is delighted to welcome Clare Price who, this week, takes up the role of Director, Clinical Development. Clare has a wealth of experience and comes to us from Starpharma. Clare spent nine years at the nanotech biotechnology company … Continue reading
The PBAC major submission deadline is nearly here. Are you prepared for lodgement?
With the March 2016 major submission deadline looming, a significant but commonly overlooked aspect are the key administrative documents that accompany a lodged submission. With a number of key documents changing, either in new process or content, as well as … Continue reading
