PQE Group

Latest Insights

Laboratory

General considerations for the analytical method validation process

The validation of analytical methods is a key requirement in the pharmaceutical industry. Learn about the three stages of the FDA guidance.

Medical Cannabis

Will Medical Cannabis Redefine Breast Cancer Care for Patients in the US?

A significant number of breast cancer patients across the US are using medical cannabis to help cope with symptoms and during treatments.

Medical Cannabis

Israeli Health Ministry Unveils Vital Medical Cannabis Reforms to Enhance Patient Access

The Israeli Health Ministry announced the eagerly awaited medical cannabis reforms in a statement published on August 7, 2023.

Medical Cannabis

Legislative Panorama: Focus On Netherlands

What is the current legislative situation in Netherlands related to Medical Cannabis?

Medical Device

New Extension on the Regulation of MD and IVD Transition Periods

The European Commission proposed to extend the certification period for medical device suppliers by 4 years to avoid shortages. Are you compliant?

RA & PhV

Elemental Impurities in Veterinary Medicinal Product

In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.

Annex 1

From Reasoning to Specifics: New GMP EU Appendix 1

The updated GMP EU Appendix 1 finally came about in August 2022. Its application is the fundamental backbone for manufacturers of medicinal products.

Annex 1

Interview with Annex 1 Expert - Giovanna Cantoni

Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni

CSV & Data Integrity

GAMP® 5 Guide 2nd Edition Release

Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.

RA & PhV

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards