Latest Insights

Cybersecurity

Cyber Threat to Healthcare and Pharma in times of Covid-19: Strategy vs. Tactical Approach

The convergence of technological platforms and the Covid-19 pandemic is creating an increasingly complex cyber threat landscape.

Cybersecurity

Evolving cyber threats in the Covid-19 era

The COVID-19 Pandemic has shifted business to remote work, contributing to widespread use of less protected devices and inconsistent network.

Annex 1

New EU GMP Vol.4 Annex I and Environmental Monitoring leverage

Learn more about new steps to improve your Enviromental Monitoring plan and where they can lead your cleanroom strategy and contamination control.

Training

Smart People & Digital Learning: an opportunity for companies

Exploring the importance of Human Capital in the Digital Transformation process.

GxP Compliance

How to perform a robust Vaccine Technology Transfer in a challenging era

Vaccine Technology Transfer is a core challenge for pharmaceutical companies that are involved in the fight to Covid-19.

Cybersecurity

Operational Technology and Cyber Security must walk hand in hand

Learn more on the key role of Cybersecurity for companies that are potential target of cyberattacks of different nature against their IT & OT.

GxP Compliance

Impact of possible removal of the Titanium dioxide from human medicines formulations was discussed during the CMDh meeting held on 14-17 September

The insight discuss the updated safety assessment of the food additive titanium dioxide (E 171) and experts concerns.

Cybersecurity

5 questions (plus, a bonus one) you should be able to answer to ensure the security of your systems

Find out from PQE experts cyberthreats may affect your Operation Technology and what Practices to perform to put OT at safe.

CSV & Data Integrity

A comparison between CSV Guideline / regulations in Japan, India and China

Find out the differences between CSV guidelines and regulations in Japan, India and China.

Medical Device

EU IVDR – Clinical Evidence and Performance Evaluation

The new Regulation 2017/746 for In Vitro Diagnostic medical devices has been published and the new requirements for Clinical Evidence are some of.