To 2019 and beyond (Brexit)…

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

 

Ivowen Xmas card 2018

 

Written by Mary Canning

mary

Company Announcement – Majella Ryan FTOPRA

MMR TOPRA fellow 10 2018 2

Majella Ryan FTOPRA

Ivowen are pleased to announce that Fellowship of The Organisation for Professionals in Regulatory Affairs (FTOPRA) has been conferred on Majella Ryan.  According to TOPRA:

The award of a Fellowship is intended to recognise a contribution in which the individual has used his/her professional knowledge and experience to influence, guide or develop the profession in a proactive way.
While clearly the individual’s regulatory experience and current senior position achieved are important, what is also looked for is a consistent record of activities or influences extending beyond the confines of the individual’s day-to-day activities.”

Majella Ryan has been in the regulatory affairs business for over 20 years and in this time has worked in both small and large multi-national companies, setting up Ivowen in 2002. Since then, Majella was involved in the set-up of TOPRA in Ireland, acting as the inaugural Chair in 2001/2011, as well as speaking at various conferences and providing extensive regulatory training to companies around the world.  In addition, Majella is actively engaged in the publication and explanation of regulatory and guidance updates via Ivowen’s website, and via Ivowen’s EU network, EuDRAcon.  As part of Ivowen’s daily work, Majella is involved in the high level regulatory strategy and support of complex projects and products like biosimilars, paediatric investigation plans and clinical trials, eCTD implementation, regulatory pathways to approval, Brexit planning, and much more.

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

 

 

 

Christmas closing times 2017

The office will be closed from Friday 22nd December 2017 to Monday 1st January 2018 inclusive for the Christmas holidays.  We wish all our friends, families, colleagues and clients a joyful festive season.  Thank you for all your custom in 2017 and we look forward to bigger and better in 2018!

animated christmas card image 0175

Merry Christmas from Ivowen

 

Ivowen shortlisted for Healthcare and Life Sciences Award 2017

Award nomination

We are delighted to announce our shortlisting for the CorporateLiveWire Healthcare and Life Sciences Award 2017.

Each year nominations are accepted for both companies and individuals. The voting process is open for 12 months and all nominees will be given the opportunity to share additional information about their business and recent achievements.

The Corporate LiveWire Healthcare & Life Sciences Awards 2017 highlight the most innovative firms and individuals who have made a different in their industry. These inspirational awards recognise and reward those in the health administration sector, pharmaceuticals and various different types of health care providers amongst others who have added value in global Health & Life Sciences service.

Ivowen is privileged to have been given this recognition and we look forward to the next stage of the process.

Ivowen hosts 2017 conference

Dublin, the venue

It was our pleasure to host the EuDRAcon conference for 2017 in Ireland on 1st and 2nd of June.  We welcomed representatives from 21 Member States, including our new member from Cyprus, Nicolas Constantinou from Niconex Medical.  EuDRAcon currently has participating members in 25 of the current 31 EEA member states, plus Switzerland, providing unrivalled EU/EEA coverage and support.

We were also grateful to Kevin Horan, Director of ICT and Business Services, HPRA who participated and provided us with valued insights into the future of ICT in the EU.

 

EuDRAcon 2017

What was discussed

The discussions included

  • an overview of local requirements specific to Cyprus (MAAs, PV, fees, pricing and reimbursement),
  • a summary of a recently successful Article 29 referral to the CHMP
  • Electronic submission roadmap
  • ISO IDMP
  • Substance, Product, Organisation, Referential (SPOR)
  • Regulatory Optimisation Group of HMA – background and work plan
  • BREXIT – what it means to us

 

For more information on any of our services, please contact us.

 

CESP expands in Poland and Greece

Latest news from Poland and Greece for CESP

From 3rd April 2017 it will be possible to submit the following procedures via Common European Submission Portal (CESP) to Poland:

  • Initial Marketing Authorisation Applications (MAAs)
  • Variations
  • Renewals

The submissions may concern national and European procedures (MRP, DCP) both for human and veterinary medicinal products.

 

Also from 3rd April 2017 the following submissions should be transmitted through CESP for Greece:

  • All submissions for Mutual Recognition/Decentralised Procedures (MRP/DCP)
  • national procedures relating to approvals, variations, renewals, PSURs, ASMFs etc., as well as any other documentation should be submitted using CESP.
  • Responses to deficiencies and any other additional information that can be requested from the EOF within the claims of assessment.

 

 

What does this mean for you?

To date in Poland, only submissions concerning initial MAAs were possible via CESP. There are still some national requirements in Poland, however.  All documents that require an original signature can be either submitted

  • in electronic version with a valid electronic signature or
  • must be submitted in parallel to CESP in paper.
  • Documentation once submitted via CESP should be submitted via this channel throughout its whole lifecycle.

For submissions into Greece, additional CD/DVDs are no longer required.  In addition, for each submission, a corresponding reference number will be automatically assigned and will be sent directly to the applicant.

 

Where can I find more information?

Full details are available on the Polish Ministry’s website (in Polish) here.

Full information is for Greece (in Greek) here.

 

We can help…

Ivowen are fully equipped to prepare and submit any applications on your behalf.  Please contact us or our EuDRAcon partners for more information and for support of your dossier compilation or updates.

Written by Majella Ryan

MMR photo

Onwards and upwards at Ivowen

alice-dalton

I am delighted to announce the promotion of Alice D’Alton to the role of Regulatory Affairs and Business Manager.

Alice has been an integral part of the team here in Ivowen for over three years and has more than 10 years experience working in the pharmaceutical industry.

This new role within Ivowen will facilitate the evolving requirements of our growing business. We envisage an expansion of our services in the coming years, continued excellence in project management and ensuring our commitment to maintaining the highest levels of quality you have come to expect from us.

I am also delighted to welcome the newest members to our team; Nanda, Emily and Rishi. They will enhance our ability to guide you through regulatory strategy, dossier preparation, MA submissions through to national phase, post-approval variations, product development, quality overviews, medical devices and much more.

Please contact us for further information.

Published by Majella Ryan

majella-ryan