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Post by 503397 on Aug 13, 2020 19:36:50 GMT 5.5
Are Patients support program or early access program cases managed as CT or PMS?
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Post by 152336 on Aug 13, 2020 19:37:26 GMT 5.5
The report type shall be other studies and not comes under PMS
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Post by 503397 on Aug 13, 2020 19:38:01 GMT 5.5
Ok thanks 👍
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Post by 152336 on Aug 13, 2020 19:38:40 GMT 5.5
Better specify source in narrative like, received from patient support program
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Post by 403202 on Aug 13, 2020 19:39:43 GMT 5.5
Are Patients support program or early access program cases managed as CT or PMS? PMS
Early access are comp. use
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Post by 741084 on Aug 13, 2020 19:40:46 GMT 5.5
It is slightly trickier than we can expect. We also need to evaluate if the drug is already approved in any other country, or it is the first time. Also if it is being evaluated for an orphan indication.
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Post by 503397 on Aug 13, 2020 19:41:08 GMT 5.5
Thanks for your inputs. For my client, there was no mandatory requirement from EMA for active monitoring as done in solicited programs, so considering it as PMS
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Post by 152336 on Aug 13, 2020 19:43:01 GMT 5.5
Patient support programs/Named patient programs/Comp use programs are type of voluntery (kind of study) programs
And to be submitted as study and not as spontaneous
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Post by 152336 on Aug 13, 2020 19:43:20 GMT 5.5
It is slightly trickier than we can expect. We also need to evaluate if the drug is already approved in any other country, or it is the first time. Also if it is being evaluated for an orphan indication. Exactly
Just be careful with respect to the type of report
Refer module VI XML section for reporting rules
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Post by 503397 on Aug 13, 2020 19:44:11 GMT 5.5
Ok. Thanks. It was very helpful.
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Post by 190686 on Aug 13, 2020 19:45:08 GMT 5.5
Ok. Thanks Ramesh and Manoj. It was very helpful. Finally how did you classify this case... Spontaneous...? |
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Post by 741084 on Aug 13, 2020 19:45:52 GMT 5.5
No straight answer. Depends on the situation
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Post by 741084 on Aug 13, 2020 19:46:34 GMT 5.5
It is slightly trickier than we can expect. We also need to evaluate if the drug is already approved in any other country, or it is the first time. Also if it is being evaluated for an orphan indication. This
PMS - if approved drug elsewhere
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Post by 190686 on Aug 13, 2020 19:47:09 GMT 5.5
It is slightly trickier than we can expect. We also need to evaluate if the drug is already approved in any other country, or it is the first time. Also if it is being evaluated for an orphan indication. Exactly
Just be careful with respect to the type of report
Refer module VI XML section for reporting rules
According to this it is spontaneous... right...? |
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Post by 190686 on Aug 13, 2020 19:47:34 GMT 5.5
Thanks for your inputs. For my client, there was no mandatory requirement from EMA for active monitoring as done in solicited programs, so considering it as PMS As per this... In absence of organised collection... It is spontaneous... Is my understanding correct...? |
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