Students taking the Regulatory Affairs Masters degree in IT Carlow met with consultants from Acorn Regulatory at our offices recently. Last week the students welcomed two of our consultants as guest lecturers to the IT Carlow campus.
Dr Gemma Robinson presented on the developments in EU regulatory affairs in the past 100 years. As part of the presentation she provided context by highlighting how healthcare crises have often resulted in heightened regulatory requirements. During the course of her presentation she highlighted issues such as the thalidomide scandal of the 1950’s and 60’s as well as the more recent Daily Telegraph investigation into notified bodies. One of the more keenly discussed elements of the presentation focused on the creation of electronic common technical documents (eCTD). During the course of the presentation she also gave an overview of the European regulatory eco-system. This included a briefing on the functions of organisations such as the Heads of Medicines Agency, the International Conference on Harmonisation and the European Medicines Agency.
Gemma Robinson spoke afterwards about the company’s association with the IT Carlow Masters in Regulatory Affairs and the basic skills that anyone seeking a career in the sector should seek to develop.
Vanessa Hyde, a senior regulatory affairs advisor at Acorn Regulatory, presented on the topic of technical writing for regulatory affairs professionals. Vanessa highlighted many of the common pitfalls associated with technical writing and guided the students through the fundamental issues of writing documents such as technical reports, clinical evaluation reports, patient information leaflets and others.
There was a lengthy question and answers session with the students that ran late into the evening. Acorn Regulatory has worked with IT Carlow on the Regulatory Affairs Masters by providing an overview of the industry, the opportunity for students to speak to consultants about regulatory issues and by presenting guest lectures.
