a number of pharma companies, as We had great to the body of legislation that would well as the WHO. She loved her time in Trinity – ‘we had great lecturers and we were encouraged to be lecturers and we were encouraged to set up EMA’. Between 1995 and 1998, she divided her time between Brussels and Prague, where she independent, free thinkers, and that has stood to me.’ Outside class, she had ‘a brief foray into ladies rugby but I wasn’t any good be independent, free thinkers, and that has stood to me worked with the Czech regulatory authority advising on EU legislation in preparation for EU membership. In 1998 she was appointed to the and I realised it was slightly risky’ but most pharmaceutical unit of the European importantly, she built lifelong friendships. Commission. As well as international ‘We call ourselves “the pharmacy girls”, the class of harmonisation and issues related to the upcoming 1978-1982, and for the past three decades, we’ve gone away EU enlargement, such as alignment of pharmaceutical somewhere different every year. Originally, they would regulation, she worked on legislative proposals for orphan come and see me wherever I was living, and then we began medicines [for rare diseases]. ‘We developed an EU-wide picking different destinations like Spain or Donegal – now approach, which made sense because numbers of patients we’re into hill walking.’ with these diseases are very small so there’s not enough After her primary degree, she did a ‘lab-based Masters in pharma-chemistry’ and then worked briefly as a community pharmacist but soon realised that it wasn’t for incentive, from a national perspective, for companies to develop medicines. With an EU approach, we were able to deliver clear benefits for patients.’ her. Her college mentor put her in touch with a regulatory In 2002 she moved to EMA as Head of Inspections. The affairs consultancy and she worked with a small Canadian agency was based in London, where she lived for the start-up setting up in Ireland, to get manufacturing next fourteen years and loved – ‘my kids spent almost all experience, before joining the national drugs regulatory their schooling there’ - but she was excited to take up the authority, HPRA, which set her on her career in medical position with the WHO in 2016. ‘You really feel that you regulation. ‘I think what fascinates me is that combination can make a difference. For instance, insulin hardly costs of understanding not only the medicines but also the legal anything and yet there are many areas in the world where environment they operate in.’ people can’t access it. Regulation enables access and that At the time, HPRA, like other national regulatory authorities was always front of my mind in the WHO.’ in the EU, was working to centralise European procedures, Like the rest of us, she spent most of 2020 working from which would eventually lead to the establishment of EMA home. When she took up the directorship of EMA, she in 1995. ‘I found that really interesting and, going right moved to Amsterdam – where the Agency relocated after back to my school exchanges in France and Germany, I Brexit – and she is now going into the office but ‘we’re an always wanted to work in Europe.’ In 1991 she moved to organisation of between 800 and 1000 people, and there Brussels to take up a position with the European Federation haven’t ever been more than 150 people in at any one time.’ of Pharmaceutical Industries and Associations (EFPIA) With the pandemic now in its third wave, if mitigated by ‘coordinating the industry scientific and regulatory input
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