Acorn Regulatory’s Essential Guide to How-To’s & Explainers

Acorn Regulatory’s website has a wealth of articles that assist regulatory, pharmacovigilance and clinical professionals all over the world.  We consistently feature ‘how-to’ and explainer articles.  This edition of the ‘Essential Guide’ looks at some of the most popular and most-read articles from our extensive archive.

Essential Guide To How To & Explainers1) Steps to CE Marking an IVD Medical Device

One of the most frequent questions we are asked is: how do you CE mark an IVD device?  In this article, we will look at the steps that you need to take to obtain when CE marking an IVD device.

As the new IVDR comes on stream, we will continue to revisit and revise this article to ensure that it is up to date.  Read the full article here.

2) Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

3) How To Prepare For A Pharmacovigilance Inspection

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. We look at the measures that your company can take to be prepared.  Read the full article here.

4) How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

  • common deficiencies
  • common validation issues
  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

5) What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.

6) How Can Remote Audits Reduce Your Pharmacovigilance Costs?

Can remote audits reduce costs for PV departments?  The remote or desktop audit is growing in popularity as client companies assess costs and the environmental impact of travelling to an audit site.  In this article, we look at the options open to companies as they seek to contain costs while maintaining standards.

Under GVP Module I, the MAH is responsible for performing risk-based audits of the quality system at regular intervals including an audit of the PV system. The methods and conduct of these audits are outlined in GVP Module IV.  Read the full article here.

7) Commonly Deficient Issues When Applying For A Certificate of Suitability (CEP)

The  Certificate of Suitability or CEP is a certificate issued by the European Directorate for the Quality of Medicines (EDQM) that certifies the compliance of a pharmaceutical substance or active pharmaceutical ingredient (API) with the requirements of the relevant monograph of the European Pharmacopeia and therefore the EU directives for medicines. A list of all CEPs granted is available on the EDQM website.  Read the full article here.

8) Using a US Dossier for a European MA Application? Here Is What You Need To Know

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you. Read the full article here.

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