Acorn Regulatory NewsAdvertisingComplianceEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory Affairs
How To Improve The Readability of Package Leaflets
What changes could be made to the readability of package leaflets to make them more accessible for patients? Eileen Shortiss, a Senior Regulatory Affairs Advisor at Acorn Regulatory is our in-house expert on all matters relating to package information leaflets. ...
Acorn Regulatory NewsEileen ShortissHow-To & ExplainersPharmaceuticalRegulatory AffairsRegulatory Strategy
Can Improvements Be Made To The Readability of Package Leaflets?
We look at the possible changes that could be made to package leaflets to improve their comprehension and readability.
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.
Do Patient Groups Have A Role In Package Leaflet Creation?
What role do target patient groups have in the creation of a package leaflet? We look at the issue and the directives concerning package leaflets in our blog.
Acorn Regulatory NewsEileen ShortissMarketing Authorisation HoldersPharmaceuticalRegulatory AffairsRegulatory Strategy
Package Information Leaflets: An Overview
Acorn Regulatory’s consultants are package information leaflet experts. We have a team dedicated to the creation and testing of package information leaflets. Members of our team have written extensively on this website and in other industry publications about the issues...
The Competent Authorities Response to Covid-19
COVID-19 has transformed almost every aspect of our daily lives. Nevertheless, patient safety must remain a priority. COVID-19 may force MAHs and regulatory authorities to operate under business continuity mode, with possible impacts on the standard of work. Public health needs may...
Acorn Regulatory NewsAcorn Regulatory's Top 100 ArticlesEileen ShortissFeatured NewsHow-To & ExplainersPharmaceutical
Medicinal Product Labelling: What You Need To Know
Every day we are presented with many different types of labels; from the laundry instructions included on clothing labels to nutritional information on food and drink packaging, labels are all around us. So what do these different types of label...
What You Need To Know About MRP Grouped Variations
We have written extensively on the topic of variations. The topic of MRP Group Variations arises regularly in conversations with clients. A number of clients have asked us to write about the issue. Here, we have outlined an overview on...
Advice On Supporting Module 1.3.4 Of A Medicinal Product Application
Senior Regulatory Affairs Advisor, Eileen Shortiss, gives advice on supporting Module 1.3.4 of a medicinal product application. This is the latest article in a series written by Eileen that looks at issues relating to labelling, leaflets and SmPC’s.
