Craigavon, N.I., 15 March 2017 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce a free, one-day exclusive knowledge sharing workshop entitled ‘Considerations for EU Product Launch’ on Thursday 11 May 2017 at The Carlton Hotel Dublin.
This complimentary workshop will discuss key aspects regarding launching a product into Europe with a focus on niche and orphan drugs and will include:
• European regulatory framework
• The importance of the role of the Qualified Person (QP)
• Key considerations for packaging, selection and design
• Strategies for stock optimisation
• Managing a complex EU supply chain
• Considerations for a temperature sensitive product
A number of Almac’s subject matter experts, including VP Commercial Operations, David Downey, will join key thought leaders from PTC Therapeutics, Shire Pharmaceuticals and Quickstat to share real world experiences and provide unique advice gained in their respective fields of expertise.
The information presented during this free workshop will guide attendees through the EU launch process, from submitting an MAA, to final distribution of drug product to the end-user. Attendees will leave the workshop with a wealth of advice and be better prepared for what is ahead and ensure their commercial launch is successful.
With over 40 years’ experience, Almac is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries. In the last three years alone, the company has supported the successful launch of more than fifteen first-to-market orphan drug products.
David Downey commented: “Companies face a number of challenges when launching a product into Europe for the first time. Almac understand the complexities involved in the entire end-to-end process and this complimentary workshop is an opportunity for us, in partnership with key industry leaders, to share our expertise, advice and knowledge in a range of pertinent areas in this field.”
To find out more and to sign up, visit: EU Product Launch Workshop Agenda.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations in the UK, Ireland, across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
