Template for scientific document (part B-E)
for an application for a <Paediatric Investigation Plan> <including> <a
deferral> <and> <a> <waiver>
<Active substance> or <INN>- (Only when INN is at least recommended)
<Trade name> <and associated trade names>- (Only in case of
authorised products)
<Applicant's name>
<EMEA-xxxxxx-PIPxx-xx>
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Application Summary
To be included by the applicant in the submission document. This
overview is to inform about the main aspects of the proposal for a PIP
and / or waiver. Please, do not exceed 750 words.
Brief description of
mode of action, including expected differences between children and
adults.
Active substance(s), class and mechanism of action: <Text>
Product name: <Text>
if already authorised in the EEA
MAH / applicant: <Text>
Name of applicant
Authorised indication(s): <Text>
in children and/or adults
Planned indication(s) in adults: <Text>
as mentioned in the PIP scientific
application
as mentioned in the PIP scientific application should be
relevant to the mechanism of action. Refer to the policy. State whether
it is “treatment”, “prevention” or “diagnosis”.
Condition: <Text>
Proposed indication(s) in children: <Text>
as mentioned in the PIP scientific
application
Outline of potential significant
therapeutic benefit for this medicinal product in relation to unmet
needs in children. A brief justification for waiver or deferral request
may also be included.
Potential benefit for children: <Text>
Summary of proposed studies (type, age,
numbers), including short justification for proposed study programme
(underlying strategy). Make transparent links to paediatric networks
and communities. Explain how feasibility of proposed studies is
ensured.
Clinical development: <Text>
Identify if there is a need for development
(based on proposed age groups and indication). If potentially yes,
describe plans including timing of availability of age-appropriate
formulation for paediatric studies.
Pharmaceutical form: <Text>
Route of administration: <Text>
Use EDQM standard terminology
Brief overview of how proposed non-clinical study
programme and / or existing data support studies and use in children.
Summarise proposed non-clinical studies or justify absence of proposed
studies.
Non-clinical plans: <Text>
If there is a possibility to extrapolate efficacy from
adults to children or from older to younger children, this should be
elaborated. Data related to extrapolation of safety information from
adults to children can also be included. Modelling of PK and/or PD if
used for decision-making should be mentioned.
Extrapolation: <Text>
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Justification for product-specific waiver or
partial waiver in relation to proposed paediatric subsets. Summarise
milestones of proposed paediatric studies, if relevant, in relation to
adult development.
Waiver(s), deferrals: <Text>
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Table of contents
Application Summary .................................................................................. 2
Table of contents ......................................................................................... 4
Abbreviations .............................................................................................. 5
Part B - Overall development of the medicinal product .............................. 6
B.1. Discussion on similarities and differences in the condition between populations, and
pharmacological rationale ............................................................................................ 6
B.2. Current methods of diagnosis, prevention or treatment in paediatric populations ......... 7
B.3. Significant therapeutic benefit and/or fulfilment of therapeutic needs ......................... 8
Part C - Applications for product-specific waivers ................................... 10
C.1. Overview of the waiver request ............................................................................ 10
C.2. Justification for a product-specific waiver .............................................................. 10
C.2.1. Applications based on a likely lack of safety or efficacy in part or all of the paediatric
population................................................................................................................ 10
C.2.2. Applications based on the disease or condition not occurring in the specified paediatric
subset ..................................................................................................................... 11
C.2.3. Applications based on lack of significant therapeutic benefit .................................. 11
Part D - Proposed paediatric investigation plan ....................................... 13
D.1. Existing data and overall strategy proposed for the paediatric development .............. 13
D.1.1. Paediatric investigation plan indication ............................................................... 13
D.1.2. Selected paediatric subsets .............................................................................. 13
D.1.3. Information on quality, non-clinical and clinical data ............................................ 14
D.2. Paediatric formulation development ...................................................................... 16
D.2.1. General strategy ............................................................................................. 16
Summary of all planned and/or ongoing, measures in the pharmaceutical development .... 17
D.2.2. ..................................................................................................................... 17
D.3. Non-clinical studies ............................................................................................ 18
D.3.1. General strategy ............................................................................................. 18
D.3.2. Summary of all planned and/or ongoing non-clinical studies ................................. 19
D.4. Paediatric clinical studies .................................................................................... 19
D.4.1. General strategy ............................................................................................. 19
D.4.2. Paediatric pharmaco-kinetic/pharmaco-dynamic studies ....................................... 20
D.4.3. Clinical efficacy and safety studies ..................................................................... 21
D.4.4. Summary of all planned and/or ongoing clinical studies........................................ 22
D.4.5. Details of the planned and/or ongoing paediatric clinical studies ............................ 23
D.5. Other studies..................................................................................................... 24
D.5.1. Modelling and simulation studies ....................................................................... 24
D.5.2. Extrapolation studies ....................................................................................... 24
Part E - Request for deferrals .................................................................. 26
E.1. Timelines of measures in the paediatric investigation plan ....................................... 26
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Abbreviations
<Text>
Any synonymous names of the product should be included here.
Abbreviations for dosing should not be used (rather, dosing should be
explicit e.g., once daily).
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Part B -
Overall development of the medicinal product
In case of several conditions, parts B, C, D and E are to be repeated
in this order per condition.
B.1. Discussion on similarities and differences in the condition between
populations, and pharmacological rationale
Summary of applicant’s position
<Text>
Populations refer to a comparison of adult versus paediatric and within
paediatric subsets.
The proposed condition(s) should be discussed in the context of current
medical practice, paediatric needs and potential use, the mechanism of
action of medicine, MedDRA classification system and relevant orphan
medicine designation(s), starting from the indication(s) being
developed and / or authorised for use in the adult population if
applicable.
Diagnosis, prevention and treatment of a disease will be considered as
separate conditions.
Description of the aetiology of disease/condition, clinical
manifestations, prognosis, epidemiology, and prevalence/incidence.
What is the paediatric age range subset concerned by the disease /
condition?
If disease does not occur in subsets of paediatric population,
potential ground for waiver.
What are the similarities regarding seriousness of the disease,
aetiology, clinical manifestations and prognosis, variability in terms
of genetic background? These should be discussed with a view to
extrapolating efficacy and/or pharmacokinetics between adults and
children, and the various paediatric subsets.
Differences based on e.g. disease pathophysiology on maturation (which
organ, receptors)?
The following pharmacological aspects are relevant:

Mechanism of action, as far as known at this stage;

The main sites of action, potential expected side effects and
pharmacodynamic drug interactions;

Is the product expected to act in the same or a different way in
adults and children and in different subsets of the paediatric
population?

Does this require separate development?
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Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
B.2. Current methods of diagnosis, prevention or treatment in paediatric
populations
Summary of applicant’s position
<Text>
Discussion of diagnosis, prevention and treatment interventions that
are available in the EU, including unauthorised treatment methods if
they represent the standard of care (e.g. if mentioned in
internationally recognised treatment guidelines).
The list of available treatments, including those authorised by the
national authorities or via the centralised procedure should be put in
the table below.
The invented name and the approved use of medical devices marketed in
the EU should be provided if applicable.
Use this table for not authorised or off label medicinal products.
Active substance or INN
Indication
Source of recommendation
(e.g.: treatment guideline)
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Use this table for authorised medicinal products.
Invented name and active
Type of authorisation (e.g.:
substance or INN
centralised, national, mutual
Indication and age groups
recognition)
Are methods for diagnosis, prevention or treatment of the condition in
question included in the inventory of therapeutic needs established
pursuant to Article 43 of the Paediatric Regulation?
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_l
isting/document_listing_000096.jsp&mid=WC0b01ac05800260a1
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
B.3. Significant therapeutic benefit and/or fulfilment of therapeutic needs
Summary of applicant’s position
<Text>
Conclusions from previous B.2 to identify unmet needs. Consideration of
the following situations of potential significant therapeutic benefit
in the proposed condition:

reasonable expectation for safety and efficacy to treat a paediatric
condition where no authorised paediatric medicinal product is on the
market;

expected improved efficacy in a paediatric population compared to
the current standard of care for the treatment, diagnosis or
prevention of the condition concerned;

expected improvement in safety in relation to either adverse events
or potential medication errors;

improved dosing scheme or method of administration leading to
improved safety, efficacy or compliance;

availability of a new clinically relevant age-appropriate
formulation;
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
availability of clinically relevant and new therapeutic knowledge
for the use of the medicinal product in the paediatric population
leading to improved efficacy or safety of the medicinal product in
the paediatric population: needs, subsets;

different mechanism of action with potential advantage for the
paediatric population(s) in terms of improved efficacy or safety;

existing treatments are not satisfactory and alternative methods
with an improved expected benefit/risk balance are needed; and

expected improvement in the quality of life of the child.
If unmet needs or presence of significant therapeutic benefit are
identified in some or all subsets, then conclude on the need to have a
PIP.
Discussion of feasibility of performing clinical trials in the
condition (lack of feasibility might be a ground for waiver).
Discussion of expected therapeutic benefit justifying paediatric trials
in the condition.
Discussion of whether new data need to be generated when there are
existing data/indication (replicating data is of no benefit).
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
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Part C -
Applications for product-specific waivers
(Complete this part if applicable.)
C.1. Overview of the waiver request
Summary of applicant’s position
<Text>
Summary of the waiver request. All subsets of the paediatric population
should be covered either by a waiver request or a PIP proposal unless
the PIP application intends to support a future paediatric use
marketing authorisation (PUMA).
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
C.2. Justification for a product-specific waiver
C.2.1. Applications based on a likely lack of safety or efficacy in part or all
of the paediatric population
Summary of applicant’s position
<Text>
Is there a likelihood of product to be ineffective based on B1 and B2
conclusions?
What is the rationale for lack of efficacy (e.g. pathophysiology, lack
of receptors, etc.)?
And/or
What is the likelihood of product to be unsafe?
Are there any theoretical safety issue from class effect?
Are there any specific safety concerns from animal studies, or from
adult population already identified?
Comment:
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Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
C.2.2. Applications based on the disease or condition not occurring in the
specified paediatric subset
Summary of applicant’s position
<Text>
Which subsets of paediatric population are excluded? Does this match
the prevalence/incidence analysed? State if this ground does not apply.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
C.2.3. Applications based on lack of significant therapeutic benefit
Summary of applicant’s position
<Text>
Is significant therapeutic benefit not expected?
Are all paediatric needs in all subsets and conditions met implying
there is no need for further development?
Does this match B.1.1 and B.3?
Comment:
Paediatric Co-ordinator:
<Text>
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Rapporteur:
<Text>
Peer Reviewer:
<Text>
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Part D - Proposed paediatric investigation plan
D.1. Existing data and overall strategy proposed for the paediatric
development
D.1.1. Paediatric investigation plan indication
Summary of applicant’s position
<Text>
This is the proposed indication in the paediatric population for the
purpose of a PIP, and at the time of submission of the PIP, within a
specific condition, for example, “treatment of acute asthma episodes”,
whereas the condition is simply “treatment of asthma”.
The Regulation considers the need for data on the potential and
correspondent paediatric use. This can be based on the mechanism of
action of the drug, on the potential for off-label use in children. The
Regulation does not require that the PIP is limited to the proposed
wording of the adult indication, but it is assumed that there should be
some relationship between development in adults and in the paediatric
population.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.1.2. Selected paediatric subsets
Summary of applicant’s position
<Text>
All subsets of the paediatric population should be covered either by a
waiver (Section C) or a PIP (section D) unless the PIP application
intends to support a future paediatric use marketing authorisation
(PUMA). In this case the application may be limited to certain
paediatric subsets without a requirement to cover all subsets.
In addition to age, the selected paediatric subsets may be based on
other variables, such as gestational age, pubertal stages and gender.
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Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.1.3. Information on quality, non-clinical and clinical data
Although the PIP is not intended to include all the elements necessary
for drug development, some requirements may have to be included.
The clinical strategy in adults should be briefly described and
commented regarding its relationship to the planned paediatric
development if relevant.
Quality: Existing formulations with regards to their relevance to the
paediatric population or subsets of the paediatric population.
Discussion of the suitability of the existing formulations for the
subsets of the paediatric population.
Summary of ADME (absorption, distribution, metabolism, excretion) and
toxicity data. Are there consequences of the ADME and toxicity data for
the pharmacological/dosing strategy in children?
Describe the main available pharmacokinetic parameters:

linearity of the kinetics, Tmax, Cmax, absolute bio-availability,
volume of distribution, plasma clearance, half-lives (T½,terminal
T½);

hepatic extraction ratio for medicinal products primarily eliminated
through the liver (comparison of plasma clearance to normal liver
blood flow)
Are there data on pharmacodynamics (effect of interest and other
effects) in animals and/or in adults? How does maturation influence the
PK-PD relationship? Is there data on the age at which 90-100 % of adult
maximum PD response as a function of plasma concentration is reached?
Non-clinical: What is known from juvenile models (corresponding
approximately to which child age)? Is there an indication that effects
on growth and/or maturation may be a concern?
Are the effects only in juvenile animals or also in adult animals?
Clinical: Is there a proof of concept of the effect of the product or
the class? Are there measures to identify the dose?
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If completed clinical studies in adults are available, summarise the
results.
Is there a need for demonstration of efficacy, or extrapolation of
efficacy from other age groups?
Is there a need for safety studies in the appropriate subsets of the
paediatric population?
Quality data
Summary of applicant’s position
<Text>
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
Non-clinical data
Summary of applicant’s position
<Text>
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
Clinical data
Summary of applicant’s position
<Text>
Comment:
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Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.2. Paediatric formulation development
D.2.1. General strategy
Summary of applicant’s position
<Text>
This section should be a logical follow-on from D.1.3 with regards to
existing formulations. The discussion should focus on the existing or
proposed pharmaceutical development of the product and address critical
issues, such as:

the need for specific formulation, pharmaceutical form, strength or
route of administration in relation to the chosen paediatric
subsets/age groups and the benefit of the chosen formulation,
pharmaceutical form, strength or route of administration;

potential issues in relation to excipients and their (anticipated)
exposure levels to be used in the paediatric population;

administration of the medicine to paediatric subsets (e.g.
acceptability, use of specific administration devices, ability to
mix with food);

precision of dose delivery and/or dose accuracy for any
pharmaceutical form, with regard to the anticipated paediatric dose
and indicated age range;

timeframe for the development of an age-appropriate
formulation/pharmaceutical form, where required; and

discuss (if applicable) medical devices in relation to dosage
accuracy and precision. Discuss ease of administration by parents,
carers, schools and older children themselves as appropriate.
If it is not possible, based on scientific justifications, to develop a
formulation/pharmaceutical form which is relevant and acceptable for
paediatric use on an i9ndustrial scale, the applicant should state how
it intends to facilitate the industry-verified or extemporaneous
preparation of an individual ready-for-use paediatric formulation.
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Refer to guidelines on pharmaceutical development, including Guideline
on pharmaceutical development of medicines for paediatric use
EMA/CHMP/QWP/805880/2012 Rev. 2.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.2.2. Summary of all planned and/or ongoing, measures in the
pharmaceutical development
Quality-related studies
This section will contain the Quality-related studies provided in the
Key element form Pdf file.
Full study synopses (if available) can be attached as a separate
document.
Furthermore if the strategy is to create age-appropriate pharmaceutical
form, formulation, strength or new route of administration, the
necessary pharmaceutical development studies may need to be more
extensive. Proposed measures of particular relevance to the development
of paediatric products include:

compatibility with paediatric administration systems, e.g. medical
devices; and

taste-making and acceptability (including palatability).
Summary of applicant’s position
<Text>
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
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<Text>
D.3. Non-clinical studies
D.3.1. General strategy
Summary of applicant’s position
<Text>
Description of the proposed non-clinical strategy to support paediatric
use in addition to classical non-clinical development.
Discussion of the need of reproductive toxicity and juvenile animal
studies.
Discussion of the prerequisites to human administration and in
particular paediatric administration. Is the product considered ‘highrisk’ (refer to guideline for ‘first in man’)?
If studies in juvenile animals are proposed, justification of the
selected species and age of animals should be put.
Do animal models exist? Are they appropriate to study the effect of the
product and to extrapolate the results?
Is there a need to study local tolerance (e.g. trans-cutaneous route of
administration)?
Is there a need to study immunogenicity?
Need for mechanistic studies if particular safety issue identified from
non-clinical development?
Are there any signals (safety) which would have an impact on the
development in children?
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
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D.3.2. Summary of all planned and/or ongoing non-clinical studies
Non-clinical studies
This section will contain the Non-clinical studies provided in the Key
element form Pdf file.
Full study synopses (if available) can be attached as a separate
document.
Summary of applicant’s position
<Text>
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.4. Paediatric clinical studies
D.4.1. General strategy
Summary of applicant’s position
<Text>
Discussion of the overall strategy for the clinical paediatric
development.
This should be in relation to the development in adults where
applicable and in relation to existing data and the potential to
extrapolate. The discussion should focus on:

possible complete or partial extrapolation from adult data to
paediatric patients and between paediatric subsets;

the interrelation, in terms of common studies, data and timelines,
between development in adults and paediatric populations; and

where necessary, a discussion on how dosing in very young and young
children is determined and verified.
Was a SA given? If so, was it followed? If not, justify why scientific
advice has not been followed.
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In case of a previous assessment by the CHMP were there issues which
would have an impact for the development in children?
Please do not discuss here the individual studies. This part is about
the approach to and rationale for development.
Is there a need for proof-of-concept in humans?
Refer to specific guideline(s) (see A.4.2) if available and discuss
their recommendation (if appropriate to paediatric development).
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.4.2. Paediatric pharmaco-kinetic/pharmaco-dynamic studies
Summary of applicant’s position
<Text>
Define the relevant subsets for PK studies and the need for PK data in
different subsets. Discuss the use of sparse sampling, PK modelling and
population PK if relevant.
Is there a need for PD modelling and clinical trial simulations?
Discuss any biomarkers for PK / PD.
Consider the following aspects where relevant:


pharmaco-dynamic studies:

pharmaco-dynamic differences between adult and paediatric
populations (e.g. influence of maturation of receptors and/or
systems);

use of pharmaco-dynamic modelling and clinical trial simulations;

discussion of any biomarkers for pharmaco-kinetics/pharmacodynamics; and

use of the pharmaco-dynamic approach, particularly where
pharmacokinetics cannot be measured; and
pharmaco-kinetic studies:

possibility of using sparse pharmaco-kinetic sampling;
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
use of pharmaco-kinetic modelling and clinical trial simulations;

use of population pharmaco-kinetics;

discussion of age groups where more extensive studies are needed,
e.g. due to expected high kinetic variability; and

pharmacogenetics.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.4.3. Clinical efficacy and safety studies
Summary of applicant’s position
<Text>
Consider the following aspects where relevant:

the need for specific dose-finding studies;

the selected efficacy and/or safety endpoints (primary or
secondary), in each of the relevant paediatric subsets;

issues of relevance across the proposed studies, such as use of
placebo or active control, age appropriateness of endpoints, use of
surrogate markers, use of alternative study design and analysis,
potential need for short-term and long-term safety studies and
differential risks by age group;

issues related to the feasibility of the proposed studies (e.g.
recruitment capacity);

any potential concern as to long-term safety or efficacy in the
paediatric population; and

specific measures proposed to protect the paediatric population
involved in development, e.g. the use of less invasive methods.
Discuss the dose-finding strategy and proposed dosing regimen
(according to weight, body surface area).
Are there any efficacy issues which would have an impact for the
development in children?
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Are there feasibility issues at this level of the development
programme?
In case of “small trials’ is there any adaptive design proposed?
Describe the proposed safety studies in the appropriate subsets of the
paediatric population. Are there any signals (safety) which would have
an impact for the development in children?
Specify the follow-up studies, time periods and whether patients are
treated or not during the follow-up.
Are there proposed long-term measures for follow-up on safety and
efficacy? Should it be part of the PIP or post-authorisation measures?
If common issue to several studies:

Discuss comparator: placebo as control, or active comparator
(authorised, not authorised/standard of care) in phase 3 trials?

Discuss endpoint(s) if common to several studies (validated scales,
non-invasive measures).

Discuss duration of active treatment.

Discuss duration of long term follow-up.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.4.4. Summary of all planned and/or ongoing clinical studies
Clinical studies
This section will contain the Clinical studies provided in the Key
element form Pdf file.
Full study synopses (if available) can be attached as a separate
document.
Summary of applicant’s position
<Text>
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D.4.5. Details of the planned and/or ongoing paediatric clinical studies
Summary of applicant’s position
<Text>
Further information, if available and appropriate to the stage of
product development, should be provided on the following:

justification of type of study, study design and methodology;

justification of the dose of the proposed product and its regimen,
and of the type of control (e.g. placebo or active control, with
dose to be used;

description of the sample size/power calculation (as appropriate;
with expected effect size in children) used to determine the
proposed number of subjects (male/female). This discussion should
include, where possible, a sensitivity analysis (a tabulation with
varying assumptions and statistical parameters, and the resulting
sample sizes);

justification of the relevant age groups or subsets included in the
study (and of staggered inclusion where applicable);

justification of the proposed duration of treatment (and duration of
post-treatment observation if included in the study);

justification of main inclusion/exclusion criteria;

justification of the choice of outcome parameters/endpoints
(primary, secondary);

justification and, if needed, a more detailed description of
statistical methods than that contained in the key elements; and

discussion of options in the event of recruitment issues.
Do not duplicate information already present in the key element form.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
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D.5. Other studies
D.5.1. Modelling and simulation studies
This section will also contain the Modelling and simulation studies
provided in the Key element form Pdf file.
Summary of applicant’s position
<Text>
If modelling and simulation
exclusive) part of the PIP,
proposed objective, data to
information already present
studies are planned as a substantial (or
justification should be put here for the
be used and methodology. Do not duplicate
in the key elements form.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
D.5.2. Extrapolation studies
This section will also contain the Extrapolation studies provided in
the Key element form Pdf file.
Summary of applicant’s position
<Text>
If an extrapolation study is planned as a substantial (or exclusive)
part of the PIP, justification should be put here for the proposed
objectives, methodology and study population. Do not duplicate
information already present in the key elements form.
Comments:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
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<Text>
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Part E -
Request for deferrals
E.1. Timelines of measures in the paediatric investigation plan
Proposed timelines.
Study
Description
identifier
Area
Date of
Date of
1
(quality, nonclinical,
clinical)
Other
2
initiation
completion
and deferral
and deferral
requested
requested
(Y/N)
(Y/N)
dependency
Summary of applicant’s position
<Text>
Requests for deferral should be justified on scientific and technical
grounds or on grounds related to public health.
A deferral could be granted if it is appropriate to conduct studies in
adults prior to initiating studies in the paediatric population or the
studies in the paediatric population will take longer to conduct than
studies in adults.
Reminder: A clinical study report is required for the PDCO to perform
the compliance check. This should be taken into account in the final
timelines of submission.
Comment:
Paediatric Co-ordinator:
<Text>
Rapporteur:
<Text>
Peer Reviewer:
<Text>
1
First patient included in trial.
2
Last patient, last visit.
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