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Posts
- 2019 – What a year
- Advanced Therapy Medicinal Product (ATMP) classification
- AIFA – Remember to submit your list of pharmaceutical sales representatives for 2021
- Applying for Marketing Authorisation via national route or DCP procedure in Ireland – HPRA slot booking
- Are you Brexit ready?
- Are you interested in online training??
- Are you ready for the Clinical Trials Information System (CTIS) implementation?
- Back to Basics – Biological Medicines
- Back to Basics – Mutual recognition procedure (MRP)
- Back to Basics – The Decentralised Procedure (DCP)
- Back to Basics – The Risk Management Plan (RMP)
- Back to Basics – Variations – Types & Timelines
- Back to Basics – Regulatory 101 – Legal basis of your MA application in the EU and UK
- Brexit – because it affects you too…
- Brexit – extension, extension, extension
- BREXIT – No extension to the transition period
- BREXIT – EVERYTHING stays the same for 2020
- BREXIT – MHRA post-transition period information
- Brexit… it’s getting closer…
- CEP 2.0 – A “new-look” CEP is here
- CESP delivery system updated
- CESP expands in Poland and Greece
- Christmas closing times 2017
- Clinical Trials Regulation EU No 536/2014 – What does this mean for you?
- Company Announcement – Majella Ryan FTOPRA
- COVID-19
- COVID-19: Still on your Radar? Current vaccine approval status and what’s on the horizon
- CPHI 2023 – There and back again !
- eCTD is coming…
- EMA eSubmission Gateway – tips & tricks
- EMA introduces changes to the QRD templates
- EMA recommends use of web-based eAF for NCA submissions (PLM Portal)
- Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….
- ERA at TOPRA 2025: Session 1 – Human – General Pharmaceutical Legislation – Sandbox
- ERA at TOPRA 2025: Session 3 – Human – Applying Artificial Intelligence in Real-Life
- ERA at TOPRA 2025: Session 4 – Human – Revision of the EU variation Regulation
- ERA at TOPRA 2025: Session 5 – Human – Programme COMBINE – Clinical Trials with Medicine + Medical Device
- ERA at TOPRA 2025: Session 6 – Human – How AI is Transforming Regulatory Approaches towards CMC
- ERA at TOPRA 2025: Session 8 – Human – ePI is on Fire! (I mean FHIR !!)
- ERA at TOPRA 2025: Tailored development of biosimilars without efficacy and safety studies – is this the future?
- ERA is proud to sponsor Public Speaking Competition in Dungarvan
- eSubmission Roadmap updated
- European Procedural Guidance during COVID-19 Pandemic
- European Regulatory Affairs Limited
- Excipient guideline update
- Falsified Medical Directive (FMD) and updated QRD template released February 2016
- Finally a survey we can all get behind! Regulatory Fees for Human Medicines
- Forum on Female Entrepreneurship
- Guidance to avoid Nitrosamines in Biological Medicines
- Happy 18th Birthday Ivowen
- How to get an Assessor’s opinion before you contact the Competent Authorities
- HPRA now part of the EU-US Mutual Recognition Agreement (MRA)
- HPRA Safety Features Workshop – update
- HPRA update on Batch-specific requests for safety features
- HPRA’s support as you prepare for Brexit……
- Impact of Paediatric Legislation on Regulatory Strategy Information Day.
- Implementation of the revised variations categories – EU and UK
- It’s our 5th Anniversary!
- Ivowen attended TOPRA Symposium 2019
- Ivowen Attending CPhI Conference
- Ivowen attends EudraVigilance Training Course on Reporting of ICSRs/SUSARs in the EEA – Suspected Adverse Reactions to Medicines
- Ivowen hosts 2017 conference
- Ivowen is hiring
- Ivowen Launch New Website
- Ivowen shortlisted for Healthcare and Life Sciences Award 2017
- Ivowen summarise TOPRA Annual Human Medicines Symposium 2015
- Ivowen to Attend CPhI Conference – October 2015
- Ivowen to Attend EGA in London 21st-23rd January 2015
- Ivowen to attend EGA PV and RA conference – January 2016
- Ivowen to Attend TOPRA Annual Symposium – October 2015
- Ivowen to Attend TOPRA Conference
- Launch of the new EudraVigilance System – National arrangements for Ireland and what this means for you
- Majella Ryan in Recent Issue of Regulatory Rapporteur
- Merry Christmas and a Happy New Year from Ivowen
- Merry Christmas from Ivowen
- Merry Christmas…….Everyone !!
- MHRA – Pharmacovigilance – Categories 1 and 2 medicinal products
- New ATC codes for 2017
- New EU MA Applications will require eCTD Submissions by Q3 2015
- New ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)
- New Logo and New Website – same great team and service
- New pharmaceutical water quality guideline from February 2021
- New UK National Procedure – Expedited 150 day procedure
- New Year, New Start, New Management….
- New Year…….New Registered Address
- News from the HPRA
- Nitrosamine impurities – current update
- Nitrosamines and responsibilities of MAHs – Deadline is approaching
- Nitrosamines Risk Assessment – Steps 2 and 3
- Nitrosamines: Step 3 Deadline Extension
- Onwards and upwards at Ivowen
- Pharmacovigilance most of all
- Points to note on the eAF
- Post Approval Change Management Protocols (PACMP)
- Preparing for Brexit
- PSUR repository updated
- Referrals to the EMA and CHMP? Keep calm and carry on.
- Regulatory Guidance updates in February 2026
- Regulatory Guidance updates in January 2026
- Regulatory Guidance updates in March and April 2026
- Regulatory Science Ireland (RSI) Seminar
- Revised ICH guideline Q3D on elemental impurities (EMA/CHMP/ICH/353369/2013)
- Still finding your feet with Remote Audits?
- Team Building … or Deconstruction … ?
- The new veterinary regulation (Regulation 2019/6) and its implications on regulatory submissions for veterinary medicinal products
- To 2019 and beyond (Brexit)…
- Type IA Annual Reporting in the UK
- UK Updates – Windsor Framework and Regulation (EU) 2023/1182 for Centralised Products
- UK updates to your Medicine – Windsor Framework and Regulation (EU) 2023/1182
- Update on the future of electronic submissions (eCTD)
- We’re hiring!
- What are the regulators doing as Covid restrictions are being lifted?
- What do I do??
- When will DADI application forms replace the current eAFs?
- Where will we be in 2016?
- You need to apply Type IA Annual Reporting in the EU in 2025
