- Starts: 22 May 2019
- Ends: 22 May 2019
Date: Wednesday 22nd May 2019
Location: Hilton Hotel, Dublin Airport, Ireland
Launching your valuable drug product can be a daunting process, especially if you are not familiar with the key milestone requirements that should be met at various time points in the MA submission process.
During this knowledge sharing workshop, our subject matter experts will guide you through the product launch timeline. Taking you from Phase III to commercial launch, we will share with you the key requirements and considerations to ensure your commercial launch is successful.
Key workshop objectives
- Learn about the European regulatory framework and how this determines all your launch milestones
- Understand the importance of the Qualified Person (QP) and QP declarations
- Discover key EU packaging considerations
- Gain insights into managing a complex supply chain
- Learn about the key Serialisation readiness requirements when partnering with a CMO
- Identify the top operational considerations as you progress to commercialisation