k.janecek2023-03-29T13:55:52+00:00April 22nd, 2022|Categories: Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, Pharma, pharmacovigilance, Regulatory|
In 2017, PRAC established a strategy for measuring the impact of pharmacovigilance activities, and EMA has published a second revision in April 2022. The second revision of the PRAC Impact Strategy integrates the achievements over a five-year period since its launch in [...]
k.janecek2023-03-29T14:01:43+00:00April 12th, 2022|Categories: Clinical Trial, Compliance, Eastern Europe, Europe|Tags: Clinical Trial, Compliance, EMA, Europe, MedTech, Regulatory, Regulatory Affairs|
EMA has published an advice to sponsors on managing the impact of the war in Ukraine on clinical trials. The ongoing war in Ukraine is affecting clinical trials. Sponsors have asked for guidance on how to handle the situation [...]
k.janecek2023-03-29T14:01:51+00:00April 4th, 2022|Categories: Clinical Trial, Compliance, Europe, Regulatory|Tags: Clinical Trial, Compliance, EMA, Europe, European Union, medicines, Regulatory, Regulatory Affairs|
The European Medicines Agency (EMA) has published an updated version of its good clinical practice questions and answers (#GCP Q&A). EMA provides guidance in forms of questions and answers on GCP, as discussed and agreed by the GCP Inspectors [...]
k.janecek2023-03-29T14:02:09+00:00March 11th, 2022|Categories: Clinical Trial, Compliance, Europe|Tags: Clinical Trial, Compliance, Europe, medicaldevice, medicaldevices, medicines, Regulatory Affairs, Spain|
The Spanish Data Protection Authority (AEPD) has recently approved the first industry code of conduct (CoC) under the General Data Protection Regulation (GDPR). The CoC has been promoted by Farmaindustria (the National Business Association of the Pharmaceutical Industry) and [...]
k.janecek2023-03-29T14:04:04+00:00March 3rd, 2022|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, EMA, eumdr, Europe, European Commission, IVD, IVDR, MDR, Medical Devices, Regulatory, Regulatory Affairs|
Now, the European Medicines Agency has control of the Expert Panels on medical devices and in vitro diagnostic medical devices. On 1 March, the coordination Secretariat of the Commission’s expert panels on medical devices and in vitro diagnostic medical devices has been [...]
k.janecek2024-02-29T16:44:37+00:00March 3rd, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: CDRH, Clinical Trial, Compliance, FDA, Medical Devices, MedTech, Regulatory, Regulatory Affairs, USA|
The FDA published a guidance on Center for Devices and Radiological Health (CDRH) Appeals Processes. The document describes the processes available to external stakeholders to request additional review of CDRH employees’ decisions or actions. It is intended only to [...]
k.janecek2024-02-29T16:24:13+00:00February 4th, 2022|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: Clinical Trial, Compliance, Europe, MHRA, Regulatory, Regulatory Affairs, UK|
The UK Medicines & Healthcare products Regulatory Agency (MHRA) has published guidance on clinical trial risk assessments, oversight and monitoring activities in two documents. It aims to assist sponsors and those conducting trials on implementing adequate oversight and monitoring [...]
k.janecek2023-03-29T14:26:12+00:00February 1st, 2022|Categories: Clinical Trial, Compliance, FDA, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) has published a new guidance for industry: Good ANDA Submission Practices. "This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs). This guidance highlights common, [...]
adminMTE_04792023-03-29T15:49:01+00:00December 1st, 2021|Categories: Clinical Trial, Compliance, Europe, MDR, Regulatory|Tags: Clinical Investigation, Clinical Trial, eumdr, Europe, European Union, MDCG, Medical Devices|
New guideline for Europe on trial changes has been published! MDCG 2021-28 - Substantial modification of clinical investigation under Medical Device Regulation. The sponsor of a clinical investigation is required to submit an application to the Member State in [...]
k.janecek2023-03-29T15:53:12+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: Clinical Trial, Complex Generic Drugs, DRUGS, EMA, Europe, European Union, FDA, Generic Drug, Hybrid Medicines, Innovation, medicines, PSA, Regulatory, USA|
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2024 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
