Industry Bodies Come Together To Host BioPharma Ambition.
Minister Simon Harris’ confirmation that the Irish government will soon be making a bid to be the new home of the EMA was one of the main talking points at the first BioPharma Ambition conference in Dublin.
Acorn Regulatory Monthly Newsletter: September 2016
We have just launched our new Acorn Regulatory monthly newsletter. You can read all of the stories from the newsletter here. If you are not already subscribing then sign up to receive the next edition.
The Implications of Brexit for the Life Sciences Sector
The implications of Brexit are still being felt. Politically, the decision has triggered a chain of events that none of us could have ever foreseen. Now, with a new Prime Minister in Downing Street and three leading ‘Brexiteers’ appointed to offices...
Get The Industry News Roundup for September
In this month’s roundup of industry news roundup, we will be looking at how the USA and Canada are working to align their submission gateways to assist companies making regulatory applications. We will also look at a new EMA drug...
Implications of Brexit for the Medical Device Sector
In this extract from our first Brexit whitepaper, written in July 2016, we look at the implications of Brexit for the medical device sector.
Brexit: The Implications on Existing Marketing Authorisations
In this extract from our first Brexit whitepaper we look at the implications of Brexit for existing marketing authorisations.
MHRA Moving Towards Paperless Communications
Following discussions with industry bodies, the MHRA is now replacing all paper-based communications with emails. The emails will replace paper-based communications about Common European Submissions Portal (CESP) submissions. Companies working with the MHRA will now receive emails to a single address...
Industry News Roundup: August
We are looking at five of the biggest stories in the pharmaceutical, medical devices and clinical trials sectors in the past month. Each month we will seek to highlight 5 key stories in trade publications and newsletters. This month we...
The Implications of Brexit on the Pharmaceutical, Medical Devices & Clinical Trials Sectors
Acorn Regulatory has published a whitepaper looking at the potential implications of Brexit on a number of healthcare sectors. The document looks at the impact of the UK’s decision to leave the EU on institutions such as the EMA. It also...
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Periodic Safety Update Single Assessment Updates
In December 2015, we published a pharmacovigilance article “Periodic Safety Update Single Assessment (PSUSA) – An Overview” which outlined the process the European Medicines Agency(EMA) take to monitor the safety of medicines in Europe. Periodic safety update reports (PSURs) are pharmacovigilance documents submitted...
