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19 04, 2019

The MRA between the EU & US

By |2019-04-19T11:07:41+00:00April 19th, 2019|Industry News|

In March 2017, it was a historical month, not just for pharmaceutical industry but for the United States of America and the European Union. The amended mutual recognition agreement (MRA) on “Pharmaceutical Good Manufacturing Practices” between the EU and the US was signed. The best outcome is that it could significantly reduce

5 04, 2019

Aer Lingus Cara Magazine Interview

By |2019-04-05T13:18:37+00:00April 5th, 2019|General News|

Now featuring in this month's in-flight Aer Lingus Cara magazine, an interview with our CEO, Ann McGee. The interview titled 'A day in the life' comes following our win at the 'Aer Lingus Start Up Awards 2018'. The interview provides a great insight into the daily routine of Ann and her busy

20 03, 2019

EU urged to safeguard post-Brexit medical supplies from the UK

By |2019-03-20T14:20:44+00:00March 20th, 2019|Industry News|

EU member-states have been urged to do more to safeguard the supply of medicines post-Brexit by European pharmaceutical leaders. The European Federation of Pharmaceutical Industries and Associations called on European leaders to allow medicines and medical devices quality which is tested in the United Kingdom, to be recognised in the European Union.

13 03, 2019

EMA now operating from Amsterdam

By |2019-03-13T14:33:51+00:00March 13th, 2019|General News|

Following the European Medicines Agency leaving its London premises on 1 March, the agency is now operating from Amsterdam. The staff will gradually move into the Spark building in Amsterdam Sloterdijk. The EMA has been working hard with the Dutch authorities to ensure these temporary premises would be ready to move into

6 03, 2019

Brexit: The EU supports pharmaceutical Companies

By |2019-03-06T14:15:26+00:00March 6th, 2019|Industry News|

When medicinal products are imported into the EU, they must undergo batch testing within the European Economic Area (EEA). Once the United Kingdom leave the EU due to Brexit, it has the following effects on the Pharmaceutical industry. Pharmaceutical manufacturers who have previously carried out batch testing in the UK must relocate

1 03, 2019

Brexit: Will UK Inspection Reports and GMP Certificates still be valid?

By |2019-03-01T10:42:34+00:00March 1st, 2019|Uncategorized|

The European Medicines Agency (EMA) has updated the agency’s Brexit-related guidance documents. The updated documents support pharmaceutical companies in preparing for the United Kingdom’s (UK) withdrawal from the European Union (EU). All medicinal products that are manufactured or imported into the European Economic Area (EEA) must be follow EU Good Manufacturing Practices

22 02, 2019

100 jobs announced at pharmacetuical services firm

By |2019-02-22T10:49:56+00:00February 22nd, 2019|Industry News|

IQVIA, the US firm that provides support services in the pharmaceutical, biotech and medical sectors have announced 100 new jobs in Dublin. They have begun recruiting in areas of clinical project management, data management and biostatistics. IQVIA stated how they are seeking pharmacovigilance specialists also. The company expect the jobs to be

20 02, 2019

Are there Brexit contingency plans for the pharmaceutical industry?

By |2019-02-20T14:24:33+00:00February 20th, 2019|General News|

In relation to the decision on whether a deal will be made or not on Brexit, the outcome will have a big threat on pharmaceutical research and manufacturing in the United Kingdom, the industry has said. This will potentially be driving up manufacturing costs and minimising future investment. A range of companies

20 02, 2019

EU-FDA MRA: Soon all States on board

By |2019-02-20T10:25:10+00:00February 20th, 2019|General News|

The EU Mutual Recognition Agreement (MRA) with the USA was increased by two further countries. The companies that have been included are Poland and Slovenia. At present, there is a total of 22 countries recognised. Germany is still missing from this Mutual Recognition. A deadline has been established for all authorities and

6 02, 2019

Clinical Trials if there is no Brexit Deal

By |2019-02-06T14:33:40+00:00February 6th, 2019|Industry News|

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) have released further guidance on how a no-Brexit deal will effect clinical trials, namely: The regulation of medicines The regulation of medical devices The regulation of clinical trials The scenario of a so called “Hard Brexit” is still a possibility and people need

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