Portolano Cavallo

Life Sciences

Blog

2 Apr 19
Patient disease registries: potential use for regulatory purposes
Public consultation on the discussion paper published by the European Medicines Agency (EMA) regarding the crucial role of patient disease registries in monitoring the safety of medicines is open until June 30, 2019.
New safety features for most prescription medicines and some OTC medicines supplied in the EU
6 Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
EMA has launched a public consultation on key principles for the electronic product information of EU medicines
2 Dec 17
Product information: EMA starts digitization
The European Medicines Agency (EMA) gives the go-ahead for digitization in terms of product information.
1 Nov 17
Positive outcome for ema’s policy 0070, one year after the publication of the clinical trial results
On October 18, 2017, the European Medicines Agency (EMA) published a report on the implementation of the Policy 0070 on the proactive publication of clinical trials results (Policy).
Welcome to the Portolano Cavallo Life Sciences blog focusing on legal development and key legal issues affecting the life sciences and healthcare industry.
...
Read more
Our highly-ranked team of professionals will provide news, insights and multidisciplinary commentary on the hottest and most recent regulatory, transactional and contentious aspects of the pharmaceutical, bio-tech, med-tech, food supplement and healthcare world with an eye on its digital transformation and technological developments.

This blog will be a place for focusing on digital health, telemedicine and artificial intelligence, as well as more traditional topics: from the protection of intellectual properties to performance of clinical trials, from the market access to advertising and competition issues, from internal and criminal investigations to M&A and venture capital transactions.

Close
March 20, 2023
Today, Regulation (EU) 2023/607 extending the transitional provisions for the placing on the market and putting into service of certain medical devices and in vitro diagnostic medical device...
January 31, 2023
Clinical trials: Ministry of Health signed off on decrees that (i) reorganize ethics committees and coordinate their activities, (ii) determine the single tariff for the authorization proced...
December 19, 2022
On 13 December 2022, EMA, European Commission and HMA jointly adopted a recommendation paper on the introduction of decentralised elements in the conduct of Clinical Trials in the EU/EEA
September 21, 2022
Payback for medical devices: Decree quantifying the exceeding of the expenditure ceiling for medical devices at national and regional level for the years 2015, 2016, 2017 and 2018 published ...
September 1, 2022
The 2021 annual law for market and competition addressing, as to the healthcare sector, reimbursement of drugs, intermediate distribution, patent linkage and institutional accreditation of p...
Search by...
Search
Follow us on
Follow us on