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…
Approval of the Data Governance Act, and EMA’s consultation on the protection of personal data in the CTIS by Giuliana Miglierini The Data Governance Act (DGA) was approved and adopted in May 2022 by the European…
PIC/S Annual Report 2021 by Giuliana Miglierini The Annual Report of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) resumes the many activities and…
EDQM, the RTEMIS scheme for remote inspections and new application forms for CEPs by Giuliana Miglierini Starting in 2022, the Real-Time Remote Inspections (RTEMIS) programme, established by the European Directorate for…