Latest Insights

Medical Cannabis

Cannabis-derived products for chronic pain treatment for cats and dogs

The use of cannabinoids in veterinary medicine is controversial for ethical and legal reasons. The approval of drugs from the competent authorities...

Clinical Research

ICH GCP E6 R3 draft guideline: main changes and clarifications

The ICH GCP E6 Working Group published the draft of the ICH GCP E6 R3 Guidance on May 19, 2023. Stakeholders can provide comments on the guideline.

Clinical Research

Recommendation on decentralized elements in clinical trials

The EU Commission released a recommendation paper on decentralized elements in clinical trials in late 2022. The document addresses the increasing...

Engineering

The importance of the contamination control strategy (CCS) in relation to Annex 1

The CCS concept permeates the entire Annex 1 document and is a fundamental principle. It indicates examples and topics that need to be addressed.

Pharmacovigilance

Is your Quality Management System effective in supporting the pharmacovigilance processes and activities? Are you ready for your next inspection?

Market Authorization Holders are now mandated to undergo the QMS to ensure compliance with the newly implemented laws of the VGVP.

Regulatory Affairs

Prevention and management of human medicinal product shortages in compliance with the recent EMA guideline on good practices for industry

2 of the 10 recommendations could be considered the main important to follow: they underline the importance to act preventing and to manage the.

Quality by Design

PQE Group view on the EU AI Act

The EU is the first to try to finally regulate AI as part of its digital strategy. The EU AI Act should pass into law in early 2024.

Medical Device

New FDA guidance on premarket submission for software: what happens now?

New FDA's guidance providing updates on the documentation recommended for inclusion in premarket submissions for its review of device software.

Commissioning, Qualification and Validation (CQV)

3W of Glove Integrity Test

Why is it important to test glove integrity in isolators or rabs and when should it be done? What norms and regulations apply to glove integrity.

Medical Cannabis

Chemotypes of cannabis (1/4)

Cannabis sativa is a dioecious plant that is widely distributed in areas with a temperate climate. The plant has three main varieties, each with its.