Before everyone breaks for the holiday season we want to wish all of our Clients, Suppliers and Friends a Peaceful and Relaxing Christmas.
2023 has been eventful (to say the least) and I am sure we are all looking forward to a nice break.
ERA office will be closed from Friday 22nd December until Tuesday 02nd January. We will be back with force in 2024 to support you in every way we can.
I have chosen to make charitable donations this year in lieu of sending cards and gifts to you via planes, trains and automobiles. We value your custom inherently and we also value our beautiful environment which won’t remain beautiful unless we look after her.
Amongst the charities we have chosen this year we have included ‘MÉDECINS SANS FRONTIÈRES’. We hope that it will go some way towards helping those Men, Women and Children faced with the devastation of war in 2023/2024.
May we all take a moment this Christmas to reflect on the things we do have. May be speak gratitude for all the love we do have in our lives. May we see how lucky we are to live in places that are untouched by war…….
I wish you joy and I look forward to seeing/speaking with you in 2024.
Ivowen wishes to announce that our beloved founder Majella Ryan has decided to retire this year.
She co-founded the company in 2002 and has spent the past 19 years working tirelessly to establish Ivowen as a no-nonsense, hardworking, one stop shop for practical regulatory solutions.
Although we are sad to say farewell, we are all very excited for Majella and wish her the very best with her new adventures once Covid is finally contained and it is safe to travel again.
The company has been taken over by our very own Alice D’Alton who is now the Managing Director. Alice has been running the company alongside Majella for the past 5 years and is dedicated to maintaining the high quality and utmost professionalism you have come to expect from Ivowen.
This will ensure that our amazing team continues to do what Ivowen does best, to guide our clients through the weird and wonderful world of Regulatory Affairs.
You can expect to see updates to our website finalised in the coming weeks as well as informative news articles on where Regulatory Affairs is heading in 2021 and beyond …
So, as always, if you need any help in registering medicines in today’s world contact us and Ivowen will gladly be here to assist you.
https://eureg.ie/wp-content/uploads/2021/02/Changing-medicine-24-02-21.jpg160240ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2021-02-24 10:42:282023-11-06 11:08:08New Year, New Start, New Management….
I am sure you will agree that 2020 has been a very trying year for all of us. Despite the restrictions, politics and challenges of working from home the regulatory world keeps on spinning. Check back in January for the latest updates from our amazing team
This year, in lieu of Christmas gifts for staff and clients, and instead of a Christmas party, the team at lvowen have each nominated a charity to receive a donation. The following are our team’s and lvowen’s chosen charities for 2020. We wish all our staff and customers a happy and safe Christmas 2020 and look forward to working with you, in 2021!
Alzheimer Society of Ireland
Concern
Cuan Saor (Women’s Refuge, Clonmel)
Cystic Fibrosis Ireland
Down Syndrome Ireland
Focus Ireland (Challenging homelessness)
Irish Cancer Society
Irish Kidney Association
Jigsaw (Youth Mental Health Ireland)
Paws Animal Rescue
Plan International Ireland (Because I am a girl fund)
Safe Ireland
St. Vincent de Paul (poverty and disadvantage)
Ivowen will be closed for Christmas this year from 24/12/20 to 03/01/21, inclusive.
Written by Alice D’Alton.
https://eureg.ie/wp-content/uploads/2020/12/Christmas-image-17-12-20.jpg12192000ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-12-17 15:52:012023-11-06 11:18:17Merry Christmas from Ivowen
Happy Birthday to Ivowen. Thanks to all our super team members, past and present – and future! And of course our many valued and loyal clients and customers, whom we are also privileged to call friends. We wouldn’t be here without any of you, and we raise a socially distanced glass of bubbles to you all!
Firstly, in this very unusual time for us all I want to let you know that our dedicated team are all healthy, safe and working from home, business as usual, to ensure that we continue to provide you with the high quality and efficient service you have come to expect from Ivowen.
Have you ever wished you could get the opinion of an Assessor before you go to the National Competent Authorities with your queries?
Well, I am delighted to introduce you to to our newest team member Claire Brown.
Claire has come directly to Ivowen from the Health Products Regulatory Authority (HPRA) and brings with her a wealth of experience as a pharmaceutical assessor of human medicinal products. Claire has been part of the team here in Ivowen since 2019 and has more than 12 years experience working in the HPRA. She started there as a Scientific Officer working mostly on veterinary medicinal products and was promoted to Pharmaceutical Assessor after 3 years.
Claire completed her undergraduate work in Chemistry and her postgraduate work in Neuropharmacology and Industrial Pharmaceutical Science.
Claire adds her extensive experience to our knowledgeable team so that we can enhance the services we provide to you and continue to give you an ‘Assessor’s eye’ opinion on your applications before you submit them.
I invite you to visit our updated Meet the Team page to see all the talented people who enable us to guide you through all aspects of regulatory strategy, dossier preparation, MA submissions through to national phase, post-approval variations, product development, quality overviews, medical devices and much much more.
If you could use some assistance to navigate the complex world of regulatory, please feel free to contact us for further information.
Written by Alice D’Alton.
https://eureg.ie/wp-content/uploads/2014/09/pharmacovigilance2.jpg3471080ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2020-03-31 19:02:032023-11-06 11:08:10How to get an Assessor’s opinion before you contact the Competent Authorities
In light of recent developments concerning the Coronavirus (COVID-19), Ivowen has put in place contingency measures to safeguard the health and well-being of our staff and to maintain business continuity.
Ivowen will monitor and adhere to Irish Government advice on delaying the spread of the virus, including but not limited to:
Staff members who exhibit relevant symptoms are to self-isolate for a period of 14 days.
Staff members travelling back from affected regions are to self-isolate for a period of 14 days.
Ivowen will withdraw from attending conferences/meetings if it is feared that attendance may pose a risk to the health of our team or help spread the virus.
In the unlikely event that Ivowen must enforce a company-wide policy of self-quarantine, our team will continue to manage and deliver your projects in a secure and reliable manner and will be contactable via e-mail and telephone.
We will endeavour to avoid delays but ask for your understanding should we need to delegate projects internally due to illness.
Ivowen attended the Medicines for Europe conference in January (Regulatory and Pharmacovigilance), the annual EuDRAcon conference in May, exhibited at TOPRA in October and joined our clients from around the world at CPhI in November.
We all saw Brexit come and go, Twice !! We wait to see what lies in store for the next deadline in January 2020.
The FMD came into effect across Europe in February in most member states.
Bulgaria joined CESP, eCTD became mandatory for all human procedures, lots of new guidance was published (to keep us all on our toes) and Nitrosamines in medicinal products moved to the top of everyone’s agenda.
With the festive season now upon us and 2020 on the horizon, Ivowen are setting our sights on the year ahead.
We will be attending the Medicines for Europe conference in January 2020 (Regulatory and Pharmacovigilance) and we encourage you to contact us before mid-January with any specific questions you might like us to ‘ask the regulators’. This is a great opportunity to ask those difficult questions that you just could not get a straight answer to in 2019, on the ever present grey areas of Regulatory procedures.
To help you to plan ahead here are some helpful updates, in brief, as full articles will be posted in 2020:
Falsified Medicines Directive – Where we are now:
Implemented on 9th Feb 2019 in all MS except Greece, Italy and Belgium
The European Commission has produced a video to explain more about the safety features.
The HPRA have extended the use and learn period, initially to Sep 2019 and extended it again to end on a phased basis starting from 31st January 2020.
The MHRA is also taking a pragmatic, flexible approach to how they enforce the new legal requirements.
Nitrosamines
Step 1: MAHs should conduct a risk evaluation to identify products at risk of N-nitrosamine formation or (cross-)contamination and report the outcome by 26 March 2020 at the latest.
Ivowen are here to assist you in 2020 and will continue to provide the top quality service you have come to expect from us.
For more information on Ivowen’s services and how we can help you, contact us.
Written by Alice D’Alton.
https://eureg.ie/wp-content/uploads/2019/12/Hot_Air_Baloon.jpg356570ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-12-06 09:52:522023-11-06 11:08:332019 – What a year
In an ever changing and at times a fast paced environment the world of pharmaceuticals demands cohesion and understanding across the board, to allow growth and success in any business either directly or indirectly involved with it. With regulations and guidelines becoming more stringent and extensive along with constant revisions and updates of the same it can be hard to keep up. It is important that you and your colleagues have an understanding of these guidelines that relate to the work that you do to ensure safety of patients and company compliance.
In certain instances guidelines and recommendations are hundreds of pages long and differ between countries, this places huge time pressure on individuals and businesses to keep up to date and often a brief read over them leaves people feeling a little confused and sometimes without even a basic understanding as to what actually needs to be done.
IVOWEN are here to help you gain a better understanding of, and, confidence in, current guidelines and technical updates. Ivowen has always offered training in many areas of pharmaceuticals but are now looking at providing these training sessions online to help our clients to gain a higher level of expertise through easier access.
We would be very grateful if you could complete the online survey we have created to help us assess how the online training sector can benefit our clients.
It takes less than 3 minutes to complete and would help us immensely:
“No company can afford not to move forward. It may be at the top of the heap today but at the bottom of the heap tomorrow, if it doesn’t.”
— James Cash Penney, founder, JC Penney
Written by Emily Fletcher
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Teams and team building is an important part of any workplace.
We recently had a rare opportunity to have all our staff members on site at the Ivowen base in Clonmel and this was the perfect opportunity to hold a team building session. It was a fun afternoon’s activity where everyone had the opportunity to take a little time out, wind down, have some fun, a lot of laughing and get to know one another a little better outside of the work zone.
We decided on a Caricaturist workshop, where we got some lessons on how to draw a Caricature and then let us test our new Artistic knowledge by drawing a team member each (these results are under lock and key unfortunately – for our eyes only!) But, we did get the professional to draw a Caricature of each team member, the results as you can see are pretty impressive but can you guess who is who??
https://eureg.ie/wp-content/uploads/2019/07/Team-building.jpg360600ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2019-07-17 14:28:122023-11-06 11:15:39Team Building … or Deconstruction … ?
