Featured Articles from the Acorn Regulatory Top 100 Articles

Our website is visited tens of thousands of times a year by professionals in the life sciences sector.  Recently we took time out to analyse the stats and we have compiled a list of the Acorn Regulatory Top 100 most read articles ever on our website.  You can see the full list and read all of the articles here.

In this blog in a series of blogs, we are looking at just a fraction of the articles and highlighting them.  There may be some that you have missed and some that you might have already read.  Nevertheless, we hope that you find them useful.

We are presenting them in no particular order and you can click the headline to read each of the posts.

1. Blog: The UK Life Science Strategy Sector Deal & The Role of Regulatory Affairs

While the UK government may not have carried out sectoral analysis of the impact of Brexit, it has developed a comprehensive industrial strategy that seeks to become the road map for the UK’s place in a global economy post Brexit.  In this blog, Brian Cleary looks at the strategy and also the role that regulatory affairs plays in the UK’s post March 2019 life science plans.

2. A Remote Audit – Could This Be An Option To Prevent Rising Pharmacovigilance Costs?

In accordance with GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV.

3. New Eudravigilance System Launched by EMA

The new Eudravigilance system, aimed at improving adverse event reporting and safety monitoring, was launched today (November 22nd 2017). The new system will allow for better collaboration with the World Health Organisation (WHO) by providing access to the WHO’s Uppsala Monitoring Centre (WHO-UMC).

4. Amsterdam To Host the European Medicines Agency

Amsterdam To Host the European Medicines AgencyThis was decided at a meeting of the EU General Affairs Council this afternoon.  Amsterdam has beaten the 18 other cities that initially entered, to win the competition.  The competition to host the agency has been hard fought and has dominated conversations of regulatory and other life science professionals since the UK decided to leave the European Union.  The agency employs almost 900 staff and there was significant coverage in recent weeks about the likelihood of staff members at The European Medicines Agency to relocate to the new host city.  Now that the decision has been made the planning to relocate almost 900 staff and their families can begin.

5. EU – US Mutual Recognition of Inspections Enters Operational Phase

The EU – US mutual recognition of inspections entered into its operational phase earlier this month when eight countries became the first territories outside of the USA to have their inspectorates recognised by the FDA.

 

6. Acorn Regulatory Takes Part in the Life Science Trends 2017 Conference

Acorn Regulatory participated in the inaugural Life Science Trends Conference in Cork earlier this week (November 15th 2017).  The conference hosted a wide range of speakers from across the sector.

7. Brexit: Implications on Existing Marketing Authorisations

One year on from the UK’s decision to leave the European Union the negotiations have begun. The life sciences sector is, perhaps, one of the sectors that will be most impacted by the result of the referendum and many companies are setting plans in place to deal with a new regulatory landscape. What are the implications on existing marketing authorisations?

 

8. Regulatory Strategy Development – An Overview

The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy. A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market their medicinal product across regions subject to different regulatory requirements.

9. Acorn Regulatory Shortlisted for Prestigious TOPRA Award

Acorn Regulatory’s Chief Marketing Officer Brian Cleary has been shortlisted for a 2017 TOPRA Award in the Communication category.

10. Acorn Regulatory Wins ‘Best SME’ at Inaugural Tipperary Business Awards

Acorn Regulatory has won the Best SME category at the 2017 County Tipperary Chamber Business Awards.  The awards ceremony was held at the Clonmel Park Hotel on Friday, October 13th.

We will look back at further articles in the Top 100 as 2018 goes on.  Don’t forget that you can look at the entire list here. If you would like to stay up to date with all of the latest regulatory affairs news from Acorn Regulatory then you can subscribe to our newsletter below.