Download ‘Regulatory Intelligence 5’ from Acorn Regulatory

We have published our latest e-book ‘Regulatory Intelligence 5’.  This edition features a number of new articles from our expert staff.  The articles look at a range of issues, many of the topics were suggested by clients or visitors to our website.  

In this edition we look at the following topics:

  • Pharmaceutical Development for Historic Dossiers
  • Good Pharmacovigilance Practice (GvP) & Social Media
  • The EU MDR & The Authorised Representative
  • Advice for Companies Attending Scientific Advice Meetings

and

  • What You Need To Know About MRP Grouped Variations

You can download the ‘Regulatory Intelligence 5‘ by completing your details below.

Have You Downloaded These Publications from Acorn Regulatory?

Drug-Device Whitepaper

The new MDR has significantly updated the requirements for medical devices placed on the European market. It has introduced new requirements for manufacturers to comply with to achieve CE marking before placing their products on the European market. Some of the principal changes are in the areas of the role of economic operators, vigilance and post-market surveillance, increased requirements for clinical evidence and expansion of the scope of products covered under the regulation when compared with the previous directives. This whitepaper provides an overview of the legislative changes, with a focus on the requirements for products that are typically known as drug-device combination products.

The drug-device whitepaper looks at issues such as:

  • the regulatory framework for devices
  • what is a drug-device product and how are they defined as such?
  • how are they regulated
  • how does MDR change the requirements for drug-device products?
  • combination products regulated as medical devices

The brief whitepaper also provides a handy drug-device checklist.

Download it here.

Download ‘Regulatory Intelligence 8’

Edition 8 of the Acorn Regulatory whitepaper series ‘Regulatory Intelligence’ is out now and can be downloaded from our site.  This bumper edition looks at a wide range of sectors including: pharmacovigilance, CMC & pharmaceutical, and medical device.

Download it here.

Download ‘Regulatory Intelligence 7’ from Acorn Regulatory

‘Regulatory Intelligence 7’ is now available to download.  It is the latest edition in our popular series ‘Regulatory Intelligence’.

This edition covers the following issues:

  • Can You Use a U.S. Dossier to Apply for a European Marketing Authorisation?
  • Clinical Investigations Under MDR
  • The U.K. PSMF -What Will It Look Like?

You can download your copy here.

Download the 3rd Acorn Regulatory MDR Whitepaper

The 3rd Acorn Regulatory MDR whitepaper is available now.  This publication looks at Clinical Evaluation Reports, Conformity Assessment Routes and Clinical Investigations under MDR.

Download the whitepaper here.

Get The Latest eCTD Publishing Whitepaper Now

Our expert eCTD publishing team has written several whitepapers on issues relating to electronic publishing.  Now, they have compiled the most popular articles from recent months into a free whitepaper for you to download.

Read the eCTD book here.

 

 

About the Authors
Brian Cleary
Chief Marketing Officer
Brian is Chief Marketing Officer at Acorn Regulatory. He works with our growing team to highlight some of the most important issues in regulatory affairs and pharmacovigilance. Brian also manages HR and recruitment issues for the company. You can read other articles by Brian by clicking the link below.
Other Articles by Brian Cleary
Christine McGrath
Senior Regulatory Affairs Advisor
Christine McGrath is an experienced Senior Regulatory Affairs Advisor at Acorn Regulatory. She works with companies around the world on issues relating to pharmaceutical regulatory affairs. At present, she is also working with our Clinical team on a groundbreaking veterinary clinical trial. You can read more articles by Christine by clicking the link below.
Other articles by Christine
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD
John Seekings
Medical Devices Manager
John Seekings manages the Acorn Regulatory medical devices team. He is an experienced device expert having spent over 20 years in the sector working with companies in Ireland, the UK, Germany, Switzerland and elsewhere.
Contact John