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
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
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.
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
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
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
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
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
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
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
