Acorn Regulatory May 2018 Newsletter

Acorn Regulatory Newsletter regulatory affairs newsletter
Hello and welcome to the May edition of the Acorn Regulatory newsletter.

Regular readers of the newsletter will have noticed that our company has been growing.  In recent months we have welcomed several new members to our team.  This month we are welcoming a new member of staff and we will introduce you to several new Acorn Regulatory colleagues in upcoming newsletters.

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 info@acornregulatory.com

Focus On: Marketing Authorisations

Members of our team have written extensively on this website and in other industry publications about the issues associated with marketing authorisations and much more.  Here we have highlighted just four articles that our team members have written on the subject in recent times. You can read the articles by clicking here or by clicking the image above.

The Worksharing Procedure for Variations for National Marketing Authorisations in the EU

Did you know that Article 20 of Commission Regulation (EC) N° 1234/2008 (the ‘Variations Regulation’) allows for a Marketing Authorisation Holder to submit the same Type IB or Type II variation, or the same group of variations affecting more than one marketing authorisation from the same Marketing Authorisation, in one application? Read more here.

Acorn Regulatory Takes Part in Enterprise Ireland & IDA 2018 Trade Mission Events

Acorn Regulatory staff took part in a number of the Enterprise Ireland & IDA Trade Mission events in Dublin and Sligo recently.

The purpose of the trade missions was to facilitate networking opportunities between Enterprise Ireland clients (of which Acorn Regulatory is one) and IDA Ireland multinational companies. Read more here.

Medical Device Services

Our medical device specialists are some of the most experienced in the regulatory sector.  They have gained a wealth of experience working with industry leaders and in national competent authorities.  Our team of specialists can become your team and they can assist you with any regulatory issues that you might need assistance with. Read more about our services for medical device companies – here:

Welcome Orla Keane

Orla Keane has joined our team as a Senior Regulatory Affairs Advisor in our Medical Devices team.  Orla joins us having spent the last 12 years with Ireland’s national authority, the HPRA.

2018 WDA E-Book

We have updated our WDA e-book for 2018 and it is available now from our website.  Simply click the link here, complete the webform and we will send you a copy of the e-book by email.

Vacancy:  Director of Regulatory Affairs (Pharmaceutical), Ireland

Acorn Regulatory has been retained by a dynamic Irish pharmaceutical company to recruit a Director of Regulatory Affairs for their expanding facility.  The successful candidate will have the opportunity to utilise their expertise in an entrepreneurial setting and to contribute to the growth of the company. Read more here.

If you are not a regular subscriber to our newsletter then you can sign up to receive our monthly newsletter by completing your details below.