Operationalizing Post-Trial Access: Planning & Running to Ensure Continued Access to Medicines
Time: 11:00 am
day: Pre-Conference - Workshop D
Details:
- Analysis factors that need to be taken into account when deciding whether to execute a PTA study and what are the alternative options?
- Highlighting the ideal time to start having conversations around running a PTA program
- Exploring are the labelling and supply requirements for a PTA depending on the country you are running it in
- Deciphering the data requirements for a PTA depending on the country you are running it in
- Evaluating whether to use commercial or clinical supply for PTA and what are each countries guidance on this
