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Who are we?
Ivowen Limited was set up in 2002 by Majella Ryan and Kay O'Shea to cater to the growing needs of generic pharmaceutical companies in the fields of Regulatory Affairs consultancy and Project Management. In July 2004 Ivowen Limited recruited a new regulatory affairs consultant, Áine Cunningham and in June 2006 Marie-Louise Nolan joined the team. Between them, they have over forty years experience in generic pharmaceuticals, ranging from formulation and analytical development to regulatory affairs and project management.
In January 2008, Audrey Butler joined us from the IMB. Audrey has over 8 years experience in the Health Authority side's handling of applications, procedures and systems.
Majella, Kay, Áine and Marie-Louise have all worked for large, multi-national generic pharmaceutical companies, which deal with both EU and non-EU marketing areas.
Kay O'Shea
 Kay has worked in the pharmaceutical sector for more than 20 years and has experience of R&D (Analytical development and validation, Formulation development, Stability, Technical support to QC, Project Management) in solid and liquid dosage forms as well as inhalation products. A number of years were spent managing an R&D Analytical aerosol laboratory at Ivax (now Teva).
Regulatory Affairs experience spans a number of employments including Clonmel Healthcare (now Stada Ireland ) and Bioglan (now Niche Generics). A number of years were spent managing a Regulatory Affairs and analytical laboratory at Bioglan with a group of 14 staff.
Since 2002, Kay has been one of the Directors of Ivowen Limited.
Key competencies in Regulatory Affairs include management of EU regulatory procedures (DCP, MRP and National Procedures), regulatory strategy for complex registrations involving value added generics, inhalation products and various other pharmaceutical dosage forms including combination products. In addition to general Regulatory Affairs, Kay also has extensive experience of managing Bioequivalence studies, including carrying out the Sponsor’s responsibilities with respect to GCP, provision of Clinical advice on study design via a network of Clinical experts, evaluation of potential CROs for completion of EU compliant studies, audits of completed studies, monitoring and provision of training to staff on the day to day management of Bioequivalence studies to meet EU expectations.
Majella Ryan
Majella has been involved in Regulatory Affairs since 1996.
Majella has run numerous parallel DCPs into all EU MSs, as well as advising clients on the development and regulatory strategy for their products. She has extensive experience with writing Quality Overall Summaries. She has also been involved in User Testing preparation and review for many generic products.
She has furthermore been responsible for the development, dossier compilation and submission of complex abridged applications for generic products, including a suspension and modified release products. These products were progressed through the EU Mutual Recognition Procedure and Decentralised Procedure. This work included full SmPC comparisons, regulatory submission strategies and full data reviews.
She has project managed more than 20 development projects, all involving development by external companies, and implemented Project Management systems within these companies.
With the Paediatric Regulation in force since January 2009, she has prepared and advised on Paediatric Investigation Plan submissions for new and combination products.
She has also prepared and reviewed toxicokinetic and risk assessments for submission to competent authorities and completed analytical method development and validation for a GLP contract research organisation, for drugs and other non-pharmaceutical compounds.
Both Majella and Kay have prepared and run training courses for numerous generic pharmaceutical companies in Regulatory Affairs, Drug Development, Sales and Marketing Opportunities, Biostudies, etc. For further information on training please go to our
Training
page.
Áine Cunningham
Áine has been responsible for the running of a Regulatory Affairs department in the Irish subsidiary of a large multinational generics company. Her key duties included the preparation and submission of standard abridged applications, variations and renewals. Áine was also responsible for the introduction of a regulatory compliance system (preparation of Standard Operating Procedures and establishing a system for regulatory compliance audits).
Áine has been involved in the development of a pharmacovigilance system which included the preparation of Product Safety Update Reports (PSUR) and maintenance of the Adverse Drug Reactions (ADR) database.
Áine has also prepared dossiers for both veterinary and human applications and has managed many applications through the national, MRP and DCP routes including post authorisation submissions, e.g. variations, renewals and transfer applications. Áine has experience with many of the EU members states in preparing electronic submissions in line with individual MS requirements (e.g. NeeS). She has also sourced and compiled harmonised SmPC, PILs and labelling and has co-ordinated readability testing with user-testing facilities.
Furthermore she has established regulatory compliance systems and performed compliance audits in various companies (both originator and generic).
In addition to the above Áine has experience in the preparation and registration of biocidal products throughout Europe, Asia, North and South America.
Áine is the responsible contact person at Ivowen Ltd. for traditional herbal medicinal products and for the area of regulatory compliance. For further information on herbal medicines and regulatory compliance please click
here
Audrey Butler 
Audrey has over 8 years experience working for one of the most well-respected Health Authorities in the EU – the Irish Medicines Board. She has varied experience in the human medicines and veterinary areas of the IMB. Her key duties included being the primary contact for applicants and Health Authority assessors alike from across the EU, including the EMEA. On a daily basis, she was responsible for the management of applications, including new MR & DCP applications, both as RMS & CMS, new Centralised applications, variations, renewals and transfers for human and veterinary medicinal products. Audrey was also a leading project team member in the implementation of the IMB's tracking and project management system, which has resulted in the IMB's assessment times being drastically reduced in the last few years.
In her capacity at the Irish Medicines Board, Audrey was responsible for the evaluation of administrative data submitted in support of applications for MRPs, DCPs, Centralised Procedures and Scientific Advice procedures for human medicinal products in accordance with EU legislation. Audrey was Case Manager for all applications involved in the above mentioned procedures, and thus was responsible for the co-ordination of applications from point of allocation to licensing of Marketing Authorisations.
Since joning Ivowen Limited, Audrey has been responsible for
- Researching, locating and booking suitable DCP/MRP slots for clients.
- Preparation and submission of Transfer Applications to various Health Authorities on behalf of our clients. This includes price applicaitons where appropriate.
- Preparation and submission of Variation Applications to various Health Authorities on behalf of our clients.
Provides full administration support in preparing and submitting of DCP applications, both paper and electronic.
For further information on any service available at Ivowen Limited, please contact us.
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