Where Next for the European Medicines Agency?In our second Brexit whitepaper, we are looking at the implications of the decision to leave on one of the most ‘mission-critical’ agencies of the EU – the European Medicines Agency. The future location of the Canary Wharf based agency is in serious doubt and the location of its new headquarters is the cause of much speculation. This whitepaper looks at how the race to secure the EMA is looking at the moment and it outlines some of the pitches being put forward by prospective hosts. We also look at how a country already beset by a skills shortage in the life sciences sector is going to have to handle a new immigration policy that may have a significant impact on its ability to attract and retain the brightest and the best. The whitepaper also looks at issues of importance to the pharmacovigilance sector and it asks ‘what changes can we expect to see post-2019’?. Those topics and others are covered in our latest whitepaper.
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Have You Downloaded These Publications from Acorn Regulatory?The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.
The drug-device whitepaper looks at issues such as:
- the regulatory framework for devices
- what is a drug-device product and how are they defined as such?
- how are they regulated
- how does MDR change the requirements for drug-device products?
- combination products regulated as medical devices
- Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
- Clinical Investigations Under MDR
- The U.K. PSMF -What Will It Look Like?