European Procedural Guidance during COVID-19 Pandemic

In response to the significant impact the COVID-19 pandemic is having on European regulatory activity, the European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (EC, EMA and HMA, respectively) have approved a number of measures to help the management of marketing authorisations for human medicinal products considered crucial during the pandemic period. The objective […]

BREXIT – EVERYTHING stays the same for 2020

 The United Kingdom has formally left the EU as of 31 January 2020 and has become what is referred to as a third country. On 1 February 2020 a transition period started which is due to end on 31 December 2020. During the transition period, EU pharmaceutical law will continue to be applicable to the UK, meaning that […]

2019 – What a year

Ivowen Limited 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 […]

Are you interested in online training??

In an ever changing and at times a fast paced environment the world of pharmaceuticals demands cohesion and understanding across the board, to allow growth and success in any business either directly or indirectly involved with it. With regulations and guidelines becoming more stringent and extensive along with constant revisions and updates of the same […]

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 […]

eSubmission Roadmap updated

The European Union updated its eSubmission Roadmap in June 2019 to reflect changes in timelines. What is it? The eSubmission roadmap is a high level, strategic plan for business and technology changes within the EU.  Its function is to align the plans and implementation timelines of target groups and stakeholders, including the EMA, National Competent […]

News from the HPRA

The HPRA are always striving to improve their processes and ways of working.  The following updates in the Human Medicines Department should help us all in our dealings with each other. New electronic workflow system The human medicines department within the HPRA have transitioned to using a new (internal) electronic workflow system. Due to this […]