Dublin, Ireland, 05 May 2022 – Orphan Drug Consulting is delighted to announce that CEO and Founder Evelyn Kelly has been selected as a finalist for the EY Entrepreneur of the Year Programme 2022. The EY Entrepreneur of the Year Programme 2022, is a world-class development programme that supports inspires, and connects a community of
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Orphan Drug Consulting is delighted to welcome Sharon Cullen to its growing international consulting team where she takes up the role of Head of Quality. Sharon Cullen is Head of Quality for Orphan Drug Consulting with extensive experience in the Life Science industry, having previously held roles in Quality Management with a focus on the Pharmaceutical
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Dublin, Ireland, 21 October 2021 – Orphan Drug Consulting Celebrates its Fourth Anniversary. Orphan Drug Consulting is proud to announce the celebration of 4 years in business. Since its establishment in 2017, Orphan Drug Consulting has grown from a core team based in Ireland to a global group with offices in Dublin, London, and Boston
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Dublin, Ireland, 12 August 2021 – Orphan Drug Consulting is delighted to welcome Jason Cameron to its growing international consulting team where he takes up the role of Chief Operating Officer. Jason has over 25 years of experience in the pharmaceutical industry working across supply chain, distribution, manufacturing, and broader technical operations, with a particular
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Introduction The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) in charge of scientific evaluation, regulation, and quality control of medicines in the EU. Before approving medicinal products for distribution in the 27 EU member states along with Norway, Lichtenstein, and Iceland, the EMA makes sure that they meet safety, efficiency, and quality standards. In relation to
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European Medicines Agency The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA’s). A marketing authorization (MA) is the authorization of a medicine to be sold in one, several, or all the European Union’s member states, depending on the type of application that has been submitted and to which agency.
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Background The Medicines and Healthcare products Regulatory Agency (MHRA) recently published guidance called “Acting as a Responsible Person (import) (RPi) from 1 January 2021”. The guidance describes the role of an RPi and how to become a RPi. Also of relevance is the guidance “Sourcing medicines for the Great Britain market from an approved country for
Read moreCountdown to Transition Period End Date Days Hours Minutes Seconds Introduction On 31 December 2020, the Brexit transition period will officially end which means that from 1 January 2021 changes to the current arrangements in place may occur. During the transitional period, the UK has remained a member of the European Economic Area (EEA), the
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Dublin, Ireland, 28 September 2020 – Orphan Drug Consulting is delighted to welcome Grainne Higgins to its growing international consulting team. Grainne’s focus will be twofold within Orphan Drug Consulting, both supporting our clients with their Human Resources needs across talent/recruitment/organizational strategy & development; in addition to providing Executive and Leadership coaching to implement best
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Dublin, Ireland, 25 August 2020 – Orphan Drug Consulting is delighted to welcome Mike Gannon to its growing international consulting team. Mike specializes in helping organizations grow and develop internationally as well as advising on optimum structures for finance, tax, treasury and business administration and support functions. Providing this expert advice to Orphan Drug Consulting
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