Blog
RSS FeedPosted 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 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 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 22 Feb 2021
EMA plots earlier engagement with patient groups
19 February 2021 - The EMA on Friday announced it will pilot an early engagement program to bring patient and ...
Posted by Michael Wonder on 09 Feb 2021
Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
8 February 2021 - As the Food and Drug Administration moves closer to a decision about whether to approve a ...
Posted by Michael Wonder on 08 Feb 2021
International regulators working together to enhance collaboration on COVID-19 observational research
8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...
Posted by Michael Wonder on 08 Feb 2021
TGA one of only five non-European regulators invited to participate on European committees on COVID-19 vaccines and therapeutics
8 February 2021 - Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate ...
Posted by Michael Wonder on 04 Dec 2020
Access Consortium statement on COVID-19 vaccines evidence
4 December 2020 - The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the ...
Posted by Michael Wonder on 27 Oct 2020
Information specialist collaboration in Europe: collaborative methods, processes, and infrastructure through EUnetHTA
21 October 2020 - The history of European health technology assessment goes back more than 30 years. Almost as old as ...
Posted by Michael Wonder on 09 Oct 2020
MHRA to join Project Orbis
8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next ...
Posted by Michael Wonder on 19 Jul 2020
Drug regulators remain united on COVID-19, says EU agency boss
18 July 2020 - The fight among governments to secure treatments has brought regulators closer together, says Guido Rasi. ...
Posted by Michael Wonder on 06 Jul 2020
Launch of public consultation on joint network strategy to 2025
6 July 2020 - EMA and the Heads of Medicines Agencies have developed a joint strategy for the next five ...
Posted by Michael Wonder on 30 Jun 2020
EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
30 June 2020 - EMA and the Ministry of Food and Drug Safety of the Republic of Korea have signed ...