If a couple had conceived on the evening of the Brexit referendum, there is a reasonable chance that the baby would be born on 29 March, the date on which the Prime Minister will finally trigger Article 50 and send notice to the European Council.  The Brexit gestation period from 23 June 2016 has not … Continue Reading
Recently, the Council of State (i.e., the Italian supreme administrative court and consultative body) adopted an important advisory opinion, which allows for improved access to investigational medicines by patients in Italy.  In particular, the Council of State found that patients may be enrolled in compassionate use programmes or supplied with a medicine listed in the … Continue Reading
This article was originally posted on our sister blog Inside Medical Devices The term “industrial scale” appears twice in the draft EU Medical Devices Regulation (“MD Regulation”) in relation to so-called “in-house devices.” The term equally appears in the draft in-vitro diagnostic medical devices (“IVD”) Regulation. To provide perspective on the meaning of “industrial scale” … Continue Reading
On 8 December 2016 the European Council published that it had adopted IORP II, which was approved and agreed by the European Parliament on 24 November 2016. The European Council set out in its publication that the directive is aimed at facilitating the development of institutions for occupational retirement provision (IORPs) and better protecting pension … Continue Reading
European Commission Outlines Data Sharing Strategy for Connected Vehicles

Connected vehicles today are rolling computers able to exchange information wirelessly with manufacturers, other vehicles, and third party service providers to significantly improve safety, efficiency, and comfort for drivers.  Many entities are interested in the data these connected vehicles generate and transmit.  These entities include dealers and repair shops, vehicle fleet service providers, end-users, infrastructure operators, diagnostics providers, researchers, financial … Continue Reading

European Commission Outlines Data Sharing Strategy for Connected Vehicles Connected vehicles today are rolling computers able to exchange information wirelessly with manufacturers, other vehicles, and third party service providers to significantly improve safety, efficiency, and comfort for drivers. Many entities are interested in the data these connected vehicles generate and transmit. These entities include dealers and repair shops, vehicle fleet service providers, end-users, infrastructure operators, diagnostics providers, researchers, financial services companies and insurance companies. The European Commission and industry actors in Europe, while recognizing the challenges of wide-spread deployment of these technologies, have taken further steps to develop a regime that facilitates information sharing for vehicle to vehicle, vehicle to infrastructure and other communications by delineating specific actions to take in the near future.

On 9 December 2016, the European Medicines Agency (“EMA”) organised a webinar for industry associations. At the webinar, the EMA presented an update concerning the implementation of the EMA policy on publication of clinical data for medicinal products for human use (“Policy 0070”) and revisions to the guidance to industry. Among the new elements introduced

The post Revisions to Clinical Data Publication Guidance extends scope of EMA disclosure power to clinical data submitted before 1 January 2015 appeared first on Focus on Regulation.