Ivowen will be attending the upcoming TOPRA’s annual symposium in Berlin from 12th-14th October. Please contact us if you would like to arrange a meeting.
Regulatory Science Ireland (RSI) Seminar, Cork, 8th September 2015
Ivowen recently attended the Regulatory Science Ireland (RSI) Seminar hosted by Dr. Kevin O’Donnell (HPRA) and Professor Caitriona O’Driscoll (School of Pharmacy, UCC), which was followed by a round table interactive Q&A session.
RSI is a new organisation that carries out research and education in the field of pharmaceutical regulatory science and is made up of a network of interested parties ranging from:
• Academia,
• Regulatory Body (HPRA)
• Pharmaceutical Industry
• Medical Devices Industry
• Government Agencies (Enterprise Ireland, Science Foundation Ireland, Industrial Development Authority)
The development of the discipline of regulatory science has been realised as a result of the ever increasing complexity of healthcare products and the requirement of a data driven evidence based approach to their regulation in the areas of quality, safety and efficacy throughout the lifecycle of a medicine. The FDA has already established Centres of Excellence in Regulatory Science and Innovation (CERSIs) and are collaborations between FDA and academic institutions to advance regulatory science through innovative research, education, and scientific exchanges. RSI is committed to the development of an integrated Irish response to the global regulatory science effort in the fields of:
• Research
• Education and Training
• Knowledge sharing
RSI will provide an effective response to the increasing complexity of healthcare products and their associated regulatory systems and will create a cohort of Irish based regulatory science experts.
Ivowen will attend further RSI Symposia later this year and in 2016, location and venues to be confirmed. See the RSI website for further information www.regulatoryscienceireland.com.
Written by Laura Oakey
Ivowen 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 from Iceland, Ymir Vesteinsson (of Day Zero).
Slovenia was chosen to be EuDRAcon president for the next year. The Slovenian representative will host the next conference which is planned for 19th/20th May 2016
We were treated to two very interesting lectures, which sparked off some lively debate.
Dr. Kerstin Stephan (BfArM) discussed with us the topic of “Medicinal Product or Food Supplement? Demarcation from BfArM point of view” and Mr. B.V. Waalwijk introduced “The future of Regulatory data exchange”.
The latter discussion raises important issues for the Pharmaceutical Industry with regard to preparing for the future of electronic submission (as opposed to the digital version of paper files we use today). It is likely in the next 10-15 years that XML databases will begin to replace scanned copies of paper files, bringing us closer to fully compliant electronic dossier.
Ivowen can help you develop, maintain and update your electronic dossier today and into the future. Please contact us for further information.
Written Alice D’Alton
Ivowen 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 of Paediatric medicines in the EMA, confirmed that the number of modifications on agreed PIPs seem to decreasing due experience gained in recent years. He went on to clarify that it is not legally possible to have a clock-stop in a PIP Modification application and advised the applicant should withdraw and resubmit.
He clarified that
Pamela Dicks, Manager at the Scottish Children’s Research Network discussed the benefits of Networks and demonstrated how Patient Information Sheets, Consent Forms, etc., can be age appropriate through the use of appropriate graphics, language and terminology.
Ivowen can help you with your Paediatric Investigation Plan applications and modifications. Please contact us for further information.
Written by Fiona Downey
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
Majella Ryan and Fiona Downey will be attending the EGA conference in London from 21st to 23rd January 2015.
Please contact us if you would like to arrange a meeting!
Ivowen will be attending TOPRA’s annual symposium from 13th-15th October in Brussels. Please contact us if you would like to arrange a meeting.
Ivowen will be attending the upcoming CPhI conference in Paris from 6th -9th October 2014. Please contact us if you would like to arrange a meeting.
Majella Ryan (Managing Director, Ivowen) was pictured in a recent issue of Regulatory Rapporteur (May 2014) attending last years TOPRA symposium.
(L-R) Sarah Thorn (KoRa Healthcare), Lisa Geraghty and Majella Ryan (Ivowen)
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Ireland.