Pharmaceutical Regulatory Affairs News – May 2017

Pharmaceutical Regulatory Affairs News

It has been a busy month at Acorn Regulatory.  Here is a recap of the top pharmaceutical regulatory affairs news stories for the past month.  Remember, you can subscribe to our monthly newsletter here and have all of the top Acorn Regulatory news stories delivered straight to your inbox.

1. The eSubmission Roadmap – What Is Happening Between Now and 2020?

The January 1st 2018 eCTD deadline is just one critical date that forms part of the overall eSubmission roadmap that looks at developments of eSubmissions between now and 2020. Read more about it by clicking the link above.

2. Virtual Wholesaling of Medicinal Products: 5 Things You Need To Know

We get asked lots of questions about WDA’s and virtual wholesaling. In this article we look at the five things that you need to know when considering virtual wholesaling. Read more about it by clicking the link above.

3. Pharmacovigilance Inspection: Are You Prepared?

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections.  In this article, we look at the measures that your company can take to be prepared. Read more about it by clicking the link above.

4. PV KPI’s: Pharmacovigilance Key Performance Indicators – An Overview

Our expert team has many years experience of working with clients to ensure that their pharmacovigilance systems are continuously improving.  In this blog we look at PV KPI’s and the steps that your company can take.Read more about it by clicking the link above.

5. Package Leaflets & Bridging Reports:  An Overview

In our second piece in a series about package leaflets, we look at consultations with target patient groups and, in particular, bridging reports. Find out more by clicking the link above.

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