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Regulatory Science Ireland (RSI) Seminar

5th October 2015

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

To 2019 and beyond (Brexit)…

4th December 2018

With the festive season upon us and 2019 on the horizon, Ivowen are setting our sights on the year ahead. So what’s going on in 2019 and beyond, including and excluding Brexit…

What’s happening in early 2019?

We will be attending the Medicines for Europe Regulatory and Scientific Affairs and Pharmacovigilance conferences in January and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’.

Brexit follows quickly on the tail of the new year, and we will all be hopefully ready and able for this new challenge. Take our Brexit quiz here to see if you are Brexit ready and contact us to help.

What’s happening in later on in 2019?

We are also looking forward to attending the annual TOPRA symposium this year, hosted in Dublin, and we hope to see you at our stand to discuss how we can assist you with your regulatory needs in 2019 and beyond.

What about us?

Ivowen consists of an amazing team with extensive experience of the pharmaceutical industry. Our aim is to understand our customer’s needs and offer services that meet those needs in a timely and efficient way.
As part of EuDRAcon, a pan European network of regulatory consultants, we can provide expert advice on all matters regulatory for the EU and beyond, including Brexit

We hope that in 2019 Ivowen can help you with your specific and unique requests.

And for now…

The office will be closed from the afternoon of Friday 21st December 2018 until Wednesday 2nd January 2019. Merry Christmas and a Happy New Year for 2019!

For more information on Ivowen’s services and how we can help you, contact us

Written by Mary Canning

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What do I do??

10th August 2016

In my circle of friends I feel like I am the “Chandler Bing” and it’s not because I am the funny one; no, it’s because no one knows or understands what I do for a living.

My mother still believes I work in a laboratory and have a working knowledge of all medicines and once even asked me, while holding a single white tablet in the palm of her hand what the tablet was for.

To be honest my description of my job has changed over the years from “you know those leaflets you get with your medicines? I help write them… do you read them? No! oh?” to “I get and control medicinal product licences in Europe”.

Sounds simple right? Unfortunately no, when I first started, the future was all “harmonisation and no more paper copies” and though it has come a long way, there are certain things that make you yell “ARE YOU SERIOUS” on a weekly basis (my colleagues have learn to ignore these outbursts). These outbursts got me thinking: what would my wish list be to make my life just that little bit easier?

Wish List

All Member States should invoice registration fees. It’s one thing finding the fee page of Competent Authority website, it’s another thing calculating the fee (did you remember the administration fee?), to understanding how to pay. I have a flow chart for one Member State!
Fully electronic, no more original, wet signature, company stamped, revenue stamped, dated and notarised, less than 6 month old paper copies (I think you know who I am getting at).
One method of submission, i.e. no national portals, CD/DVD, paper, parallel submissions (if France can improve so can every Member state).
Marketing Department: please make up your mind! A week before submission and you decide you want extra Member States added/deleted to the upcoming DCP… at least give me two weeks!
Finance Department: No, I can’t shop around for a better price for a national variation.

Please let me know if you have any wishes to improve your work life and maybe Ivowen can help you (or least sympathise with your struggle).

Written by Fiona Downey

Tag Archive for: Regulatory Affairs

Regulatory Science Ireland (RSI) Seminar

To 2019 and beyond (Brexit)…

What’s happening in early 2019?

What’s happening in later on in 2019?

What about us?

And for now…

What do I do??

Need help with all the regulatory jargon?

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