‘Selected Writing: 2018' Download It Now

‘Selected Writing: 2018’ highlights just some of the best received and most read articles from our website in the past year.  It looks at an array of issues including:

• Repeat Use Procedures.
• Pharmacovigilance Audits.
• Brexit.
• Well-Established Use.
• Scientific Advice Meetings.
• Patient Information Leaflets.
• The Medical Device Regulations
• Changes to regulatory demands.
• Smart Packaging.

Selected Writing also contains an overview of what has been happening at Acorn Regulatory in the past twelve months. 2018 was a particularly busy year for the company.  Aside from winning the Co. Tipperary Chamber Business Award for Best Use of Social Media & Digital at the October awards, the company was also shortlisted/placed as a finalist in other competitions such as the TOPRA Awards and the Irish Pharma Awards.  You can read more about these events and our participation in them by downloading ‘Selected Writing: 2018’. You can download ‘Selected Writing: 2018’ by completing your details below. [ninja_form id=49] This e-book contains innovative and informative writing on regulatory issues.  Our team regularly write informed articles on issues relating to regulatory affairs, pharmacovigilance, quality compliance and more on our regular blogs and in our series of e-books.

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.