Supply chain issues Flashcards
1
Q
IMP supply chain
A
- Manufacture of IMP – requires IMP license
- Qualified person certifies and releases IMIP
- IMP distribution/import
- Clinical trial site for patient use
2
Q
How to effectively access the orphan drug space?
A
- Patients/parents – ask them what they want to achieve
- Professionals who researched disease
- Drug repurposing
- Legislations
- Funding
- Companies that do x treatment
3
Q
Supply chain complexity
A
- Very specialised and complex medicine
- Very few patients, so small batches
- Patients far apart in the world
- Biological medicines – complex manufacturing process
