Resources

How Can Decentralised Trials Foster Patient-centricity: An Insider Look

Nov 18, 2021 | Digital Transformation, Resources

Read this interview to discover how Life Sciences companies can embrace patient-centricity in R&D in a way that benefits patients the most.

Risk Management Requirements for Post-Market Surveillance for Medical Devices

Nov 17, 2021 | Resources

Medical Device Regulation: what is it about? The EU’s Medical Device Regulation (MDR) is a hot topic in healthcare since it was officially published on 5th May 2017 and came into effect on 25 May 2017. The MDR replaces the EU Medical Device Directive (93/42/EEC) and...

Webinar Q&A | PSUR under the Medical Device Regulation: Practical Guide

Nov 17, 2021 | Pharmacovigilance, Resources, Webinars

In this blog article, we are answering questions received during the Q&A session of our webinar “PSUR under the Medical Device Regulation: Practical Guide”.

How to Embrace Digital Transformation in Life Sciences

Nov 8, 2021 | Computer System Validation, Digital Transformation, Resources

Read this interview to discover how Life Sciences businesses can embrace Digital Transformation effectively and harness its power.

The MDR: Medical Device PSUR as per Regulation (EU) 2017/745

Oct 6, 2021 | Resources

Regulation (EU) 2017/745 also known as the MDR, applicable since May 26th 2021, introduced a new obligation for the medical device manufacturers – according to the Article 86, they are obliged to prepare the medical device Periodic Safety Update Report (PSUR) for...

Transforming Your Pharmacovigilance

Jul 5, 2021 | Pharmacovigilance, Resources

Learn how to choose the safety database that will transform your pharmacovigilance department.

eTMF – Your Key to Inspection Readiness

Jun 30, 2021 | Regulated Document Management, Resources

Discover how evolving beyond paper-based processes and adopting an eTMF help ensure inspection readiness.

How to Increase the Benefits from Your Remote Monitoring Solution

May 12, 2021 | Resources

Discover how the business analysis approach can help you to choose the remote monitoring solution that is the most beneficial for you.

Practical Advice for Your Next Remote GVP Audit

May 12, 2021 | Quality, Resources

From on-site audits to remote audits The global spread of COVID-19 amongst other challenges has resulted in travel and work restrictions. This crisis has changed the way Life Sciences companies approach the GxP audits and forced them to look for new solutions that...