Global contract development and manufacturing organisation (CDMO), Almac Group, has announced two events to discuss the key aspects surrounding launching a product in the European market.
US and EU
These free, one-day exclusive knowledge sharing workshops, titled ‘Almac Product Launch Workshop’, will be held in San Diego and Boston in September and will focus on niche and orphan drug launches in the EU.
Some of the key topics being covered 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 optimization
- Managing a complex EU supply chain
- Considerations for a temperature sensitive product
Various Almac’s subject matter experts, such as Brian Eastwood — head of BD (Europe) — will deliver discussions throughout the sessions along with key opinion leaders from McGee Pharma International, Vertex Pharmaceuticals and Optel Vision.
“Companies face a number of challenges when launching a product into Europe for the first time,” commented Eastwood. “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.”
The workshops will take place on 26 September at the Andaz Hotel in San Diego, California, and on 28 September at the DoubleTree by Hilton Hotel, Downtown Boston, Massachusetts.