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Latest Insights

Clinical Studies

Are you already in compliance with ICH-GCP and EMA's Guideline on computerised systems?

Learn how the new EMA guideline on computerised systems is shaping the future of clinical trials. Discover the challenges of electronic systems and.

Medical Device

Clinical trials involving Medical Devices and Medicinal Products. How can we manage regulatory assessments?

Learn how to manage regulatory assessments for clinical trials for medical devices and medicinal products. Understand different scenarios and.

Laboratory

Three Key Aspects to Ensure Reliable Results in a Quality Control Laboratory

There are general skills that should be considered when working in a laboratory, among which we highlight three.

GxP Compliance

mRNA product manufacturing: the future of biotech world

Covid-19 vaccines are an example for the success of mRNA technology, but not everyone may know that mRNA therapeutic products have been studied for.

Medical Cannabis

Legislative Panorama: Focus On Denmark

Denmark has a relatively small cannabis market compared to other European countries, primarily due to strict regulations and high prices.

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?