Launching your drug product onto the European Market can present a real challenge if you are not familiar with country specific requirements, particularly if you are based in the U.S. With its 27 member states, numerous official working languages and complex regulatory framework, this workshop will clarify the key requirements for a successful EU product launch.
This workshop will guide you through the EU product launch process, from submitting your MAA to final distribution of drug product to the end-user.
Key workshop objectives:
· Learn about the European regulatory framework & the various market access strategies
· Understand the importance of the role of a Qualified Person (QP)
· Discover how applying late stage customisation can reduce stock holding
· Determine supply chain requirements for temperature sensitive products
· Listen to real-life experiences from 3 US Pharma companies who have successfully launched product in Europe
* Key speakers include: Eisai Inc, Millennium: The Takeda Oncology Company, The Medicines Company and NDA Regulatory Sciences Ltd
When & Where
Almac is a financially stable, privately owned organization with over 3,300 employees located within the US and UK.
Almac offers a broad range of services from API manufacture, pharmaceutical development, clinical trial supply to commercial-scale manufacture and packaging.
- Opening of a new $10m non-GMP facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.
- FDA approval of our new US Commercial Packaging facility in Audubon, PA. Offering commercial primary and secondary packaging of tablets and capsules into bottles, blisters, wallets and hospital unit dose formats along with secondary labelling and packaging of sterile presentations (vials, ampoules, syringes etc).
Over 600 companies worldwide, including all the market leaders, use our services, testament itself to the quality, innovation and efficiency of our business as proven over the past 40+ years.