Open Menu
Modification of the Drug Master File (DMF) Form
1 May 2023 – the Swissmedic published the modified DMF form.
Read more online Read
Changes to the Forms for New Authorizations of and Variations to Human and Veterinary Medicinal Products
1 May 2023 – the Swissmedic published information on study design and data sources of RWE in application forms.
Read more online Read
Medical Devices Swissmedic Hospital Inspections 2021/2022 Annual Report
12 May 2023 – the Swissmedic published the 2021/2022 annual report of the Swissmedic Hospital Inspections on Medical Devices.
Read more online Read
Changes to the Guidance Document GMP Compliance by Foreign Manufacturers and the Form Declaration by the Responsible Person for Foreign Manufacturers
1 May 2023 – the Swissmedic published updated guidance documents on clarification of the requirements for the submission of audit reports.
Read more online Read
ICH E6(R3) Good Clinical Practice Guidance – Step 2 Public Consultation
2 May 2023 – the UK MHRA Inspectorate announced Step 2 – Public Consultation – of the ICH GCP guidance.
Read more online Read

More Articles...

  1. Notify the MHRA about a Clinical Investigation for a Medical Device
  2. Guidance on Qualified Person Responsible for Pharmacovigilance (QPPV) Including Pharmacovigilance System Master Files (PSMF)
  3. Register Medical Devices to Place on the Market
  4. Reporting Adverse Incidents Involving Software as a Medical Device under the Vigilance System
Contact

Widler & Schiemann AG can provide you with innovative, creative and cost effective answers to your questions and needs in the areas of Clinical Quality Management.

Recent Facebook Posts
Most Popular
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /