Well, I am fresh back from CPHI 2023, held in Barcelona this year and here are some of the highlights:
This year was the busiest CPHI yet and the atmosphere on the show floor was vibrant. Over 52,000 passionate professionals from around the world gathered in the massive conference centre (Fira Gran Via) to connect with 1,800+ exhibitors, face-to-face at the heart of pharma.
To say it is a sight to behold is an understatement and its hard not to get swept up in the activity each year (Tiring – Yes, Boring – definitely not) !!
Eight massive halls, packed full of exhibition stands with many cafes, restaurants and meeting spots in between.
The Garden spaces on the first floor were a nice addition but unfortunately I didn’t get a chance to relax in any of them….
The use of the CPHI app really made things easier this year. I was able to plan and book meetings, bookmark lectures and sessions I wanted to attend, highlight companies I was interested in visiting and connect with attendees via the integrated messaging tool to request introductions, meetings and collaborations. Very easy to use and convenient. The integrated floorplan and directions tool was also really handy.
All aspects of Pharma are represented at CPHI and not surprisingly the Biologics section was huge this year….
It was great to catch up with current contacts, explore new collaborations and best of all to meet people face to face.
I expect to attend next year in Milan and hope you will reach out to arrange a face to face if you are also attending. Contact us at info@eureg.ie.
Written by
Alice D’Alton
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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
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.
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.
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EudraVigilance (http://eudravigilance.ema.europa.eu) is a centralised European database of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA) and supports the safe and effective use of medicines (Figure 1 – EudraVigilance System Components). Adverse reactions (ADRs) can be reported during the development and following the marketing authorisation of medicinal products in the EEA. The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
ICSR, SUSAR and Safety Signals
Specifically, EudraVigilance is a system for managing and analysing information on suspected adverse reactions to medicines by facilitating electronic exchange of adverse event Individual Case Safety Reports (ICSRs) between EMA and all stakeholders including national competent authorities (NCAs), marketing authorisation holders (MAHs) and sponsors of clinical trials in the EEA. Within clinical trials such a case is referred to as a SUSAR (a Suspected Unexpected Serious Adverse Reaction). The reporting of ICSRs allows for the early detection and evaluation of possible safety signals leading to improved product information and benefit-risk balance for marketed medicines authorised in the EEA. A Safety Signal is defined as information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies and the scientific literature.
Taking into account the pharmacovigilance activities in the pre- and post-authorisation phase, EudraVigilance provides two reporting modules:
The EudraVigilance Post-Authorisation Module (EVPM)
Electronic reporting of suspected adverse reactions to medicines is mandatory for MAHs and sponsors for clinical trials. Ivowen can advise and assist you in the following areas of reporting to EudraVigilance along with updating product information for PRAC recommendations:
Describe the Registration process with EudraVigilance
Create, validate and send safety messages (initial, follow-up reports, nullification reports, literature reports, parent-child , study reports, reports with medical and drug history)
Create and send acknowledgments of received ICSR messages
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Ivowen recently attended the HPRA Safety Features Workshop Athlone (3rd May 2016). The following is a summary of the key take-home points from this workshop.
Introduction of a Unique Identifier (UI) and Anti-tampering Device (ATD) on Packaging of POM and Certain OTC Medicines
Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on safety features (Commission Delegated Regulation (EU) 2016/161) may impact the product information of MAs. The Delegated Regulation applies to medicinal products for human use and specifically prescription only medicines (POM) and certain non-prescription/over-the-counter/general-sale-list medicines (OTC/GSL).
All POMs are required to carry safety features, with the exception of radiopharmaceuticals and those products listed in Annex I of the Regulation (EU) No 2016/161 (“white list”)
Categories not subject to prescription; OTC/GSL medicines are not required to carry a safety feature unless they are listed in Annex II of the Regulation (EU) 2016/161 (“black list”). The black list includes documented evidence of falsification of medicines other than POMs e.g. omeprazole
The purpose of the safety features is to allow for the identification and authentication of human medicinal products
The safety feature including ATD must be placed on the outer packaging or in the case of no outer packaging on the immediate packaging (if the ATD affects the container closure system, then information on how the ATD affects the container closure system is required in section 3.2.P.2.4 and/or 3.2.P.7 of the MA dossier)
Products outside the scope of the Delegated Regulation include veterinary, investigational, and exempt medicinal products. Additionally medicinal products manufactured in the EU and destined for export only are also exempt.
Composition of the Unique Identifier (UI)
Manufacturers will be required to encode the unique identifier in a 2-D barcode and to print data elements in human-readable format.
2-D Barcode
The 2-D barcode will consist of a sequence of numeric or alphanumeric characters.
Product Code: allowing identification of at least the Tradename, common name, the pharmaceutical form, the strength, the pack size and the pack type
Serial Number: a numeric or alphanumeric sequence of maximum 20 characters
Reimbursement Number: if required by the Member State
Batch Number
Expiry Date
Human-readable Format
In addition to the 2-D barcode manufactures will also be required to print the data elements in human-readable format so as to allow the verification of the authenticity of the unique identifier and its decommissioning in case the two-dimensional barcode is unreadable.
Anti-tampering Device (ATD)
Manufacturers Choice of tamper evident seal.
The Regulation shall apply from 9th February 2019 where all relevant medicinal products placed on the market or QP certified will need to have the new safety features in place. The safety features may be implemented in advance of this date provided the functioning repository is in place and the MA dossier has been updated to include reference to the safety feature. MA holders are advised to update product information during the 3-year transition period and this can be done during any ongoing regulatory procedure (e.g. Renewal, Variation IA, IB, II, new or existing MAA application) – no additional fees; or alternatively submit an Article 61(3) Notification – usual fee will apply.
Further detailed guidance can be found under the following links:
Ivowen can assist you in notifying competent authorities of the safety features and updating your MA dossier for new, on-going and existing MAAs. Ivowen are also fully eCTD-ready and compliant. Please contact us for more information and for support of your application.
Written by Laura Oakey
https://eureg.ie/wp-content/uploads/2016/06/HPRA-e1565191076271.png111200ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2016-06-22 15:26:392023-11-06 11:08:12HPRA Safety Features Workshop – update
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
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Ivowen will be attending the upcoming 9th EGA Pharmacovigliance, and the 15th EGA Regulatory and Scientific Affairs Conference in London from from 27th-29th January. Please contact us if you would like to arrange a meeting.
https://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svg00ERAadministratorhttps://eureg.ie/wp-content/uploads/2023/10/European-Regulatory-Affairs-Logo.svgERAadministrator2016-01-26 17:22:432017-09-01 14:29:44Ivowen to attend EGA PV and RA conference – January 2016
Alice D’Alton from Ivowen was delighted to be asked to provide a summary of Session 4 at the recent TOPRA Annual Human Medicines Symposium 2015. The full summary is provided in the following link:
Ivowen will be attending the upcoming CPhI conference in Madrid on 13th-14th October. Please contact us if you would like to arrange a meeting.
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