Tag Archive for: TOPRA

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.




Ivowen attended TOPRA Symposium 2019

This year’s TOPRA Annual Symposium was held in Dublin in October. The Annual Symposium is an essential meeting for regulatory professionals to gain both an understanding of current and evolving regulatory requirements, as well as insights into future plans for regulations in the Human medicines, Veterinary medicines and Medical Device sectors.

Three members of our Team attended the Symposium this year, Majella Ryan, Alice D’Alton and Nanda Naik. This year was particularly satisfying for Ivowen as we had an exhibition stand at the three day event.

As well as exhibiting, Ivowen attended the sessions including ‘Life after Brexit’. This session was a live discussion of predictions and concerns about the possible outcome of ongoing negotiations with the EU.

Now that an extension has been granted, which will delay the UK exit until January 2020, we are left wondering if we will finally know the UK position when Ivowen attend the Medicines for Europe regulatory conference being held in Amsterdam on 29th – 31st January.

In the meantime, we await instruction from the regulators on whether UK will still be available on the CESP portal later this week. Ivowen is registered on the new MHRA submissions portal so either way we have you covered.

Ivowen will keep you up to date in the coming days and weeks

Please contact us, Ivowen are dedicated to keeping you up to date with the latest regulatory updates and innovations. We remain at your disposal to assist in all of your regulatory endeavours today and into the future.

Written by Alice D’Alton.

Where will we be in 2016?

We are already in Quarter 2 of 2016 and as it comes to the end of April we thought it necessary to update current and potential clients as to where we will be and where you can meet us in 2016.

As a company providing expert advice and support to our clients we at Ivowen feel it is very important to actively seek out new regulatory information, to equip ourselves with knowledge on what is ‘coming down the line;’ keep abreast of industry and legal developments, and, to remain ahead of the game with regard to regulatory updates and new proposals. Conferences and continuing professional development is an integral part to providing our clients with the best service.

At present we will attend the following conferences/workshops; please feel free to say ‘hi’ and ask any questions; we always welcome opportunities to meet with current and potential clients and build relationships.


3rd May.

Venue: Sheraton Hotel Athlone, IRELAND

Information: HPRA 2016 Safety Workshop

This workshop is aimed at the implementation of safety features on outer packaging of specified medicines for human use.

The EU Falsified Medicines Directive (FMD) 2011/62/EU, introduces the requirement for manufacturers / Marketing Authorisation Holders (MAHs) to add safety features (that include an unique identifier) to the outer packaging of specified medicines for human use and to fund an Europe-wide verification system which will enable the authentication of medicines before the unique identifier is decommissioned and the pack is dispensed to a patient.  The mandatory implementation of the regulation must be completed no later than 3 years from its publication, i.e. by the 9th February 2019.  Updates on this course to follow soon – watch this space!


19th-20th May.

Venue: Hotel Slon, Ljubljana, SLOVENIA.

Information: 14th annual EuDRAcon conference

We will be attending the 14th  EuDRAcon conference in Slovenia. 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. The conference this year will be hosted by MediSanus d.o.o.


28th-30th September.

Venue: Medicines Evaluation Board, The NETHERLANDS

Information: 13th Annual TOPRA symposium

The 13th annual symposium for TOPRA is being held in Amsterdam this year. This symposium cover topics such as public health needs, update on legislation for orphan drugs, paediatrics and pharmacovigilance, clinical trial regulation, drug-device combination products, regulatory science etc. More information is available at: https://www.toprasymposium.org/ .  We shall be attending the conference in its entirety.


4th-6th October.

Venue: Fira de Barcelona Gran Via, Barcelona, SPAIN

Information: CPhI Worlwide exhibition

CPhI worldwide exhibition offers the opportunity to ‘keep abreast of the latest industry developments: stay up-to-date on market news and trends during the Pre-Connect Conference, CPhI Pharma Innovation Award, free sessions in Exhibitor Showcases (Previously Speakers’ Corner), Free Content – Pharma Insight Briefings.’ This exhibition also offers the chance to connect with companies and people in the pharmaceutical industry from around the world. More information is available here: http://www.cphi.com/europe/


During the year we may also be attending other conference/events/training, please get in touch if you would like to meet us at an event; or if you or your team require training in any aspect of EU legislation or MRP/DCP/CP and CTD systems for registering generic drugs in the EU, which is our speciality.

If you have any queries on the above, would like to organise a meeting, or if you have any other queries please contact us . If you see us at any of the events please do come and say ‘hello.’ We are looking forward to meeting everyone.


Written by Emily Fletcher EF photo