Hello and welcome to the April edition of the Acorn Regulatory newsletter.
This month we are looking at Repeat Use Procedures, Clinical Breaches and we have another of our very well received ‘Regulatory Intelligence’ e-books. The e-book is filled with articles from our expert team. You can download a PDF of the e-book by clicking the link below.
As always, we welcome any thoughts that you may have on the articles that we are highlighting and you can get in touch with us by emailing firstname.lastname@example.org
Download ‘Regulatory Intelligence 3’
The latest edition of our e-book series looks at a number of the critical issues in the regulatory sector today. Our experts have written a number of insightful articles and you can read them by downloading the e-book. ‘Regulatory Intelligence 3’ looks at a number of the critical issues in today’s regulatory sector. Get your e-book here.
Acorn Regulatory Takes Part in EI Trade Mission to Italy
Acorn Regulatory’s Managing Director Dr. Gemma Robinson was one of a number of Irish life science entrepreneurs who took part in Enterprise Ireland’s recent Trade Mission to Italy. In this blog Gemma writes about the initiative and the companies that she met while participating in the trade mission. Read more here.
Repeat Use Procedure – An Overview
In this article, we look at the issue of Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process. Read more here.
Acorn Regulatory Case Study: Obtaining A Certificate of Suitability (CEP)
We worked with a major US manufacturing firm to obtain a CEP. Our team worked closely with the manufacturing company to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP has been accepted and its certificate granted! Many thanks to Acorn Regulatory for the tremendous work that was done. Your strength, patience and flexibility in working with us was paramount in this success”. You can find out more about the CEP process and the steps we took to successfully obtain the certificate of suitability for our client in the case study below. Read the case study here.
GDPR & The Life Sciences Sector
The introduction of the General Data Protection Regulation (GDPR) presents a particular challenge for the life science community. The regulation is being implemented to better protect the privacy of consumers data and, as such, there is a concern from within industry that it will stifle developments in medical science.In this overview, written by Acorn Regulatory’s Quality Systems Specialist Mandy Cashman we look at the main issues relating to GDPR from the perspective of the consumer and the client. Read it here.
In this article we look at the possible changes that could be made to package leaflets to improve their comprehension and readability. Read more by clicking here.
We have produced a number of articles on the issue of package leaflets and you can read them here.
Guidelines For Notification of Serious Breaches of Regulation (EU) No. 536/2014
Marie Carroll from our regulatory team looks at the steps that need to be taken when there is a serious breach of EU regulation No. 536/2014. The European Medicines Agency describes the regulation as:
The goal of Clinical Trial Regulation EU No. 536/2014 is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.
Read more here.
What We Have Learned About Work Flexibility
In our latest careers blog Brian Cleary looks at the issues that we encountered while undertaking our large recruitment drive in the first quarter of 2018. We look at work flexibility and the options that we enable our staff to take. Read the careers blog here.
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