Orphan Drug Consulting Celebrates Four Years in Business

ODC 4 Years

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 […]

World Orphan Drug Congress 2021

WODC 2021

Join us at World Orphan Drug Congress 2021 November 15-18, 2021. Orphan Drug Consulting is delighted to be exhibiting at World Orphan Drug Congress 2021 taking place as an event in Barcelona, Spain from 15th – 18th November 2021. Find us at booth 8. Join Jason Cameron at World Orphan Drug Congress as he presents […]

CPhI Worldwide 2021

CPhI Worldwide 2021

Join us at CPhI Worldwide 2021 November 9-11, 2021. The in-person event will take place at the Fiera Milano in Milan, Italy. Join us to connect with new partners face-to-face, network, and source innovative pharma solutions on-site from thousands of exhibitors covering the entire pharma supply chain. CPhI Worldwide showcases each stage of the pharmaceutical […]

Orphan Drug Consulting Appoint Jason Cameron as Chief Operating Officer

Jason Cameron

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

EMA Labelling and Packaging

  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

EU Marketing Authorisat

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

EU Marketing Authorization Procedures

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

EU Marketing Authorization Procedures

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

Grainne Higgins Orphan Drug Consulting

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 […]