Regulatory Affairs Industry News Roundup – June 2017

Pharmaceutical Regulatory Affairs News

It has been a busy month at Acorn Regulatory.  Here is a recap of the top regulatory affairs industry 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. EU Parliament Adopts New Diagnostics and Medical Device Regulations

The European Parliament has endorsed the new InVitro Diagnostic Medical Devices (IVDR) and the new Regulation on Medical Devices (MDR) at a sitting today (April 5th 2017).  The long awaited final vote is the last step in an almost 8-year process to update the legislation that was first written in the 1990’s.

2. Brexit Whitepaper No. 4 – What’s Next? – Download It Here

In our 4th Acorn Regulatory Brexit whitepaper entitled ‘What’s Next’ we focus on the results of our extensive Brexit survey.  We look at our survey respondents favoured locations for the EMA, the future of the MHRA and much more.

3. 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.

4. 10 Responsibilities of an EU Authorised Representative

The responsibilities and role of the EU Authorised Representative (or EC Rep) is now in the spotlight as a result of the UK’s decision to leave the EU.  Many companies have previously chosen EU Authorised Representatives from the UK and, as a result of the referendum, will now need to choose a new representative within the EU. In this blog post we will look at the 10 of the main responsibilities of an EU Authorised Representative.

5. 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.

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