Orphan Drug Consulting Appoint Jason Cameron as Chief Operating Officer
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 […]
EMA Labelling and Packaging Regulations
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 […]
EU Marketing Authorization Procedures
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. […]
Acting as a Responsible Person (import) (RPI) in the UK
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 […]
BREXIT: Approved Country Lists Post-Transition Period
Countdown 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 […]
Orphan Drug Consulting Appoint Grainne Higgins as Human Resources Consultant
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 […]
Orphan Drug Consulting Appoint Mike Gannon as Financial and Entity Planning Consultant
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 […]
Orphan Drug Consulting Open Office in Boston, MA, and Appoint Christy Webb as US-based Consultant
Dublin, Ireland, 20 July 2020 – Orphan Drug Consulting today announced the opening of office space in Boston, Massachusetts, and the further growth of its US-based consultant team with the appointment of Christy Webb as a Quality Assurance consultant. This further expansion into the US market by Orphan Drug Consulting addresses an increased demand for […]
Orphan Drug Consulting Appoint Tanya Quinn as US-based Consultant
Dublin, Ireland, 02 June 2020 – Orphan Drug Consulting is delighted to welcome Tanya Quinn (through her company Knowledge Base LLC) to its international consulting team. Tanya will support Orphan Drug Consulting with its growing client requirements in the US from her New York/New Jersey-Metro location. Tanya is a well-respected, experienced senior supply chain management […]
EU Regulatory Flexibility During COVID-19 Pandemic
In these uncertain times it can be challenging to comply with regulatory requirements while maintaining supply demands, but there has been advice published by the authorities to help. This guidance has outlined regulatory flexibility that can be applied to help pharmaceutical companies cope with the consequences of the pandemic, while ensuring a high level of […]