Almac Group Announces US Workshops Targeting EU Product Launch Best Practices
August 10, 2017
Craigavon, N.I., UK, 7 Aug 2017 – Almac Group, the global contract development and manufacturing organisation, is delighted to announce two free, one-day exclusive knowledge sharing events titled “Almac Product Launch Workshop” on Tuesday, September 26th at the Andaz Hotel in San Diego, CA and on Thursday, September 28th at the DoubleTree by Hilton Hotel, Downtown Boston, MA.
These complimentary workshops will discuss key aspects regarding launching a product into Europe with a focus on niche and orphan drugs, including:
- European regulatory framework
- The importance of the role of the Qualified Person (QP)
- Key considerations for packaging, selection and design
- Strategies for stock optimization
- Managing a complex EU supply chain
- Considerations for a temperature sensitive product
A number of Almac’s subject matter experts, including Head of BD (Europe), Brian Eastwood, will join key thought leaders from McGee Pharma International, Vertex Pharmaceuticals and Optel Vision to share real world experiences and provide unique advice gained in their respective fields of expertise.
The information presented during these free workshops 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 workshops with a wealth of advice and be better prepared for what is ahead to 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.
Brian Eastwood commented: “Companies face a number of challenges when launching a product into Europe for the first time. Almac understands the complexities involved in the entire end-to-end process and these complimentary workshops are 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.
‘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 development and commercialisation, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over almost 50 years and now employs in excess of 5600 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).