Over the course of the past year we have produced a wide range of whitepapers, ebooks and other publications. Here are the 5 most read publications from Acorn Regulatory in 2018
The issue of wholesale distribution authorisations or wholesale dealer authorisations (WDA) remains a hot topic in regulatory and quality circles. For many, the issue of Brexit has ‘muddied the water’ somewhat. Anecdotal evidence would suggest that there has been a large increase in the number of companies seeking WDA’s from the HPRA in Ireland. Read and download it here.
Using a U.S. Dossier for a European MA Application, Well Established Use and other topics are covered in the latest edition of our regulatory magazine. ‘Regulatory Intelligence 3’ looks at a number of the critical issues in today’s regulatory sector. Read and download it here.
Sector specialists need to stay on top of developments in the sector. That is why we have produced another edition of our e-book series. ‘Regulatory Intelligence 2’ looks at a number of the critical issues in today’s regulatory sector. Read it and download it here.
As regulations and guidelines become broader, more electronic and increasingly data driven, manufacturers must adapt with ever changing regulatory demands. Regulators are shifting more responsibility onto manufacturers to instill quality throughout their operations and throughout their product lifecycles. In the past, small and emerging life sciences companies might have functioned sufficiently with manual processes and disconnected systems, but may now be unable to satisfy the requirements of regulators whose fundamental shift is a growing focus on electronic processes, data driven decisions and increased transparency to information. Read it and download it here.
The course of Brexit has been filled with dramatic twists and unexpected happenings. The resignations of David Davis, Suella Braverman, Steve Baker and Boris Johnson have thrown the UK’s plans into disarray. While many of us did expect the Irish border issue to be one of some complexity, there was no expectation that it might derail the entire negotiations, as it almost did, in December 2017. Likewise, who would have thought that the decision on the new host city for the European Medicines Agency would have been decided by the drawing of lots? The 6th Acorn Regulatory Brexit Whitepaper looks at issues such as the predicament that the EMA faces when trying to maintain operations and move from London to Amsterdam and much more. As apparent chaos unfolds in the UK parliament on issues related to Brexit, we look at the implications for the ever more likely ‘no deal’ scenario. Staff shortages, trade tariffs, supply chain bottlenecks and worse could befall businesses. This whitepaper looks at the likelihoods and plans that you can put in place now to protect your business. Read more here.
