The Windsor Framework
On 27 February 2023, UK Prime Minister Rishi Sunak and the European Commission President Ursula von der Leyen…
EDQM introduces a consultation phase in the management of CEP documents
by Giuliana Miglierini The new process implemented by the European Directorate for the Quality of Medicines and HealthCare…
ICMRA report on best practices against antimicrobial resistance
by Giuliana Miglierini Antimicrobial resistance (AMR) is the consequence of mutations that allow microbes to survive pharmacological treatment.…
The FDA warns about the manufacture medicinal and non-pharmaceutical products on the same equipment
by Giuliana Miglierini A Warning Letter, sent in September 2022 by the US FDA to a German company…
Patient involvement in the development, regulation and safe use of medicines
by Giuliana Miglierini The Council for International Organizations of Medical Sciences (CIOMS) has published the CIOMS report on…
Current inspection trends and new approaches to the monitoring of post-inspection activities
by Giuliana Miglierini The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published its Annual Regulatory GMP/GDP…