Italy was the first and among the hardest-hit countries in Europe by the COVID-19 pandemic. Emergency regulation for COVID-19 clinical trials and compassionate uses...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
3/16/2020
/ China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
EU ,
Good Clinical Practices ,
Infectious Diseases ,
Italy ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health
This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more
7/19/2019
/ Advertising ,
Appeals ,
Clinical Trials ,
Court of Justice of the European Union (CJEU) ,
General Court of the European Union (GCEU) ,
Intellectual Property Protection ,
Marketing Perspectives ,
Non-Use of Trademarks ,
Pharmaceutical Industry ,
Regulatory Standards ,
Revocation ,
Trademarks
On December 14th, 2017, the Italian Senate passed a long-awaited bill (DDL no 2801) governing the informed consent to medical treatments, which also allows individuals to express their wishes on medical treatments in the...more
Fast track for orphan diseases and rare forms of cancers -
By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new...more