Category Archives: E-Health/Technology
Relating to E-Health and Technology in the Life Sciences Industry
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
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
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
Medical Information by instant message
1800 numbers and written responses such as letters and emails are a well-established part of all Medical Information services. However consumers and healthcare professionals are increasingly tech-savvy. They may prefer to communicate via text or online chat as they do … Continue reading
A PV database to meet your needs… and your budget
Just as medicines and medical devices are held to stringent quality controls, so too is the software used to support the safety and efficacy of those same medicines and medical devices. Choosing a pharmacovigilance (PV) database for your business can … Continue reading
New FDA draft guidance risks ‘Confused Consent’
Clinical trials require researchers to ensure that each participant is fully aware of the details of the trial before they take part. The FDA’s recently released draft guidance for Institutional Review Boards (IRBs), clinical investigators and sponsors on Informed Consent … Continue reading
People Trends – Reverse to Go Forward
People Trends is also a new regular feature of Eye Spy. This month we focus on reversing the mentoring process and creating a two-way exchange between the younger and the more experienced personnel. Continue reading
Top 5 – Budget 2012
For many Eye Spy readers, the best outcome to emerge from Budget 2012 was that the PBS remained unchanged. So, we had to look a little deeper into the Budget papers to find the Top 5 Health announcements. Continue reading
The Top Five Apps Your Medical Department Must-Have
This month’s Top Five countdown describes some affordable apps that have the ability to turn your medical department into a paper-free environment. Continue reading
TGA and Electronic Submissions
How to create a submission that is easy to navigate and evaluate. Continue reading
