Key Considerations for a Successful EU Orphan Drug Launch

Life Sciences, Pharmaceutical Regulation, Pharmaceutical, Commercialization & HEOR,
  • Thursday, September 08, 2016

Launching an orphan drug product onto the European market can present a real challenge if the company is not familiar with country specific requirements. With its 28 member states, numerous official working languages and complex regulatory framework, this webinar will clarify the key requirements for a successful EU product launch.

The speakers in this webinar are experts in navigating market requirements and supporting client partners to successfully launch their orphan drug products into Europe. They have extensive practical experience in the areas of regulatory, quality, packaging design and distribution of launching products into the various EU markets, ensuring launch timelines are met and market entry strategy is successful.

During this interactive webinar, the speakers involved will utilise their experience to guide attendees through the EU orphan drug launch process, from submitting Marketing Authorisation applications to final distribution of drug product to the end-user.

By participating, attendees will gain insight into:

  • The European regulatory framework
  • The importance of the role of a Qualified Person (QP) and European market release requirements.
  • Key European packaging considerations (Regionalisation, Blue Box, Serialisation)
  • Supply Chain considerations for a temperature sensitive product

Attendees will also have the opportunity to participate in a live Q&A Session.



David McCoubrey, Senior Regulatory Affairs Scientist, Almac

David has worked in the Scientific Affairs Department of Almac Group for the past six years. His experience encompasses development, pre-approval and post-approval regulatory activities. This includes the management of scientific advice meetings, compilation and submission of clinical trial applications, and the management, compilation and submission of new Marketing Authorisation applications for medicinal products in the EU. David also has experience with the maintenance of INDs and NDAs for US drug products. He has prepared, submitted and maintained EU and US orphan designations, including managing pre-submission teleconferences with the European Medicines Agency and FDA.

After graduating from Queen’s University Belfast with a Masters degree in Pharmacy, David completed his training as a Pharmacist with Alliance Boots. He worked as a Pharmacist Manager for the company for three years before joining Almac.

Message Presenter

Orla Hartnett, Qualified Person, Almac

Orla joined Almac Group in 2009 as a Qualified Person. Orla has over 15 years’ experience in Quality Control and Quality Assurance for oral, solid dosage forms, powder dosage forms and non-sterile liquids, with experience in QC/QA aspects of formulation and development projects from phase I clinical supplies through to scale-up for commercial operations, as well as the monitoring of commercial operations.

Orla has been involved in the initiation and management of commercial importation projects for a range of sterile and non-sterile Pharmaceutical dosage forms. She has advised clients in the EU requirements for QP certification of imported products, and has been an active participant in project teams involved in the launch of commercial imported products onto the EU market.

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Michael Rooney, Senior Business Support Manager, Almac

Michael has over 15 years’ experience working in the Pharmaceutical industry including 6 years in Project/Product Supply Management. In this time he has been responsible for leading multi-disciplinary teams consisting of personnel from QA, QC, Packaging Design, Production and Logistics, in order to support a number of challenging, but ultimately successful product launches/site transfers and on-going commercial supply to global markets.

After graduating from University of Ulster with a degree in Applied Biochemical Science, Michael went on to spend 3 years as an Analytical Chemist for a major US Pharmaceutical company, where he gained valuable experience with analytical transfers, validation, stability and EU Import analysis.

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Emma Jordan, Distribution Manager, Almac

Emma is responsible for the Distribution Department within Almac Pharma Services. The Distribution Department is responsible for the processing of customer sales orders and managing the despatch of cold chain and ambient material throughout Europe and Rest of World. The expansion of the services being offered to Pharma Services clients means that Emma is responsible for the development of the 3PL, cold chain despatch, Late Stage Customisation and Supply Chain Qualification processes for the company.

Emma joined Almac Group in 2012 after graduating from University and has held different roles within the Logistics Department of the company. She has gained significant experience in several fields within Logistics where she was responsible for negotiating contracts with suppliers and working with Clients to develop bespoke distribution strategies for their products.

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Who Should Attend?

Professionals from Pharmaceutical and Biotechnology companies involved in the field of Orphan Drug Development and Commercialization, including:

VPs/Heads, Directors and Managers of:

  • Supply Chain
  • Manufacturing
  • Packaging/Labeling
  • Quality Assurance
  • Regulatory Affairs
  • Commercial Operations

Xtalks Partners


With over 40 years’ experience, Almac is an FDA and EU approved outsourcing partner to the global Pharmaceutical and biotechnology industries. Having successfully partnered in the commercial launch of many of the industry’s recent first in class, innovative orphan drug products in areas such as Cystic Fibrosis, Muscular Dystrophy, Hemolysis and Short Bowel Syndrome, Almac leads the CMO field in integrating its services to support orphan drugs.

Assisting client partners to achieve launch timelines and maximise product flexibility to serve global markets, Almac offer a full range of product launch support services including:

Product launch consulting services
Regulatory support for EU filings
EU import testing and QP market release
Packaging design and artwork generation
Customised packaging solutions
Order processing and financial services
Storage and end-user distribution (Ambient, Cold, Frozen & Controlled Drugs)
Benefiting from integrated Pharmaceutical and distribution from a single supply team, clients minimise effort and maximise return.


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