In UK pediatric clinical trials protocol is known as planned pediatric investigation plan
Pediatric Investigation Plan (PIP)
Pediatric investigation plan is the plan which ensures that the useful data obtained through the study in the children. In short the clinical trial which is carrying out on the children is known as the pediatric investigation plan (PIP) in UK.
As per the pediatric regulation in UK, company has to submit the PIP wherever possible. For ensure the quality, safety and efficacy of pediatric drug, PIP is mainly required.
A PIP is a development plan aimed at ensuring that appropriate pediatric studies are performed to obtain the necessary quality, safety and efficacy data to support the authorization of a medicine for …show more content…
In these cases, pediatric studies can be deferred until these studies have been conducted and confirmation is available that it is safe and ethical to initiate studies in pediatrics or specific age subsets.
Notification of intent to submit: An applicant should notify the MHRA of their intent to submit an application for a PIP, and/or a request for waiver or deferral, in the form of a Letter of Intent at least two months in advance of the planned submission date.
Pre-submission meeting: The PIP application procedure offers applicants the opportunity of a pre-submission meeting with the MHRA to discuss the draft package. The purpose of the pre-submission meeting is to assist applicants in submitting valid applications that will aid in a smooth review procedure.
Submission: Following the pre-submission meeting the application is refined and a final package submitted to the MHRA according to published timelines. The MHRA will validate the submission package within 30 days; the date of successful validation is taken as Day 1 of the
Pediatric Investigation Plan (PIP)
Pediatric investigation plan is the plan which ensures that the useful data obtained through the study in the children. In short the clinical trial which is carrying out on the children is known as the pediatric investigation plan (PIP) in UK.
As per the pediatric regulation in UK, company has to submit the PIP wherever possible. For ensure the quality, safety and efficacy of pediatric drug, PIP is mainly required.
A PIP is a development plan aimed at ensuring that appropriate pediatric studies are performed to obtain the necessary quality, safety and efficacy data to support the authorization of a medicine for …show more content…
In these cases, pediatric studies can be deferred until these studies have been conducted and confirmation is available that it is safe and ethical to initiate studies in pediatrics or specific age subsets.
Notification of intent to submit: An applicant should notify the MHRA of their intent to submit an application for a PIP, and/or a request for waiver or deferral, in the form of a Letter of Intent at least two months in advance of the planned submission date.
Pre-submission meeting: The PIP application procedure offers applicants the opportunity of a pre-submission meeting with the MHRA to discuss the draft package. The purpose of the pre-submission meeting is to assist applicants in submitting valid applications that will aid in a smooth review procedure.
Submission: Following the pre-submission meeting the application is refined and a final package submitted to the MHRA according to published timelines. The MHRA will validate the submission package within 30 days; the date of successful validation is taken as Day 1 of the