EMA introduces changes to the QRD templates

The EMA has introduced changes to the QRD templates of the product information that accompany all medicines authorised for use in the EU including package leaflet (PL) and the summary of product characteristics (SmPC). Full details are available here: Summary of Main Changes: The changes to Quality Review of Documents (QRD)  templates are detailed in […]

Update on the future of electronic submissions (eCTD)

Ivowen Limited recently attended the annual EuDRAcon conference in Lörrach, hosted by the German representative, Finkler. [EuDRAcon is an abbreviation for European Drug Regulatory Affairs Consultants. It is a pan-European network of regulatory affairs consultancy companies dealing with drugs, medical devices, cosmetics and food supplements] We began the event by voting in the newest member […]

Impact of Paediatric Legislation on Regulatory Strategy Information Day.

Ivowen Limited recently attended Topra’s Reviewing the Impact of Paediatric Legislation on Regulatory Strategy Information Day.   On the morning of the solar eclipse the clouds may have left us feeling disappointed, however the silver lining was definitely the frank and honest presentations regarding the PIP legislation which followed that day.   Paolo Tomasi, Head […]

New EU MA Applications will require eCTD Submissions by Q3 2015

Marketing Authorisation Applications for human use submitted using the Decentralised Procedure (DCP) will need to be provided electronically as eCTD by Q3 2015. Submission in eCTD for Mutual Recognition Procedures (MRP) will also be required by the start of 2017, and finally National Procedures by the start of 2018. eCTD is already required for Centralised […]

Forum on Female Entrepreneurship

Majella is delighted to have been asked to speak at the LEO Forum on Female Entrepreneurship this Wednesday, 22 April. Book your place now: https://www.localenterprise.ie/Tipperary/Training-Events/Online-Bookings/?date=22%2F4%2F2015

We’re hiring!

Are you an experienced Regulatory Affairs professional looking for a new challenge in a dynamic and fast-moving consultancy?  Then we may be the fit for you.  Have a look at our requirements on our Vacancies page here and send in your CV if interested.  Of course, we are always interested in receiving inquiries from people […]