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 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.
