Blog
RSS FeedPosted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 03 Jun 2021
HumanFirst joins the FDA, HHS and more than 20 organisations and leading health companies to launch the Digital Health Measurement Collaborative Community
3 June 2021 - Digital Health Measurement Experts will work together to develop best practices and streamline health measurement using digital ...
Posted by Michael Wonder on 01 Jun 2021
EMA and EUnetHTA take stock of their co-operation
1 June 2021 - The EMA and the European Network for Health Technology Assessment (EUnetHTA) have published a report on ...
Posted by Michael Wonder on 31 May 2021
New EU health innovation rules edge closer
29 May 2021 - Three years after the original proposal, the European Union’s game changing Health Technology Assessment dossier has ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
Posted by Michael Wonder on 11 May 2021
The pharma industry needs to measure patient experience from the patients’ perspectives
10 May 2021 - The relationship between clinical outcomes and the patient experience — the sum of all of interactions ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 10 May 2021
The Government and Medicines Australia jointly agree to finalise patient centric strategic agreement after the Budget
8 May 2021 - Medicines Australia has been working closely with the Minister and his Department since last year to ...
Posted by Michael Wonder on 07 May 2021
The National Audit Office's review can contribute to strengthening TLV's work
7 May 2021 - On 6 May, the National Audit Office published its report on the Government's and TLV's work ...
Posted by Michael Wonder on 29 Apr 2021
Developing a quality management system for the European Network for Health Technology Assessment (EUnetHTA): toward European HTA collaboration
27 April 2021 - The European Network for Health Technology Assessment (EUnetHTA) was established in 2006 and comprises over eighty organisations ...
Posted by Michael Wonder on 14 Apr 2021
Patient and public involvement in health technology assessment: a new dawn?
12 April 2021 - Patient and public involvement and engagement have become increasingly embedded in health technology assessment over the last ...
Posted by Michael Wonder on 06 Apr 2021
Development of an international template to support patient submissions in health technology assessments
1 April 2021 - The objective was to develop an international template to support patient submissions in health technology assessments. ...
Posted by Michael Wonder on 28 Mar 2021
MHRA pilot seeks evidence of patient involvement in R&D
25 March 2021 - The UK MHRA has begun a pilot project to encourage patient involvement in drug development, asking ...
Posted by Michael Wonder on 05 Mar 2021
TGA adopts Access Consortium guidance for fast-tracking authorisations of modified COVID-19 vaccines for variant
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
Posted by Michael Wonder on 04 Mar 2021
Modified COVID-19 vaccines for variants to be fast-tracked, says MHRA and other regulators
4 March 2021 - Future vaccine modifications that respond to new variants of coronavirus to be made available quickly to UK recipients, without compromising on safety, ...