Prequalification: Training Workshop
POSTPONEMENT: New dates and location of the
training workshop to be posted. Please check this page
Training Workshop on Pharmaceutical Development with a Focus
on Paediatric Formulations
generally recognized that there is to some extent, a lack of
background scientific and clinical data; and information and
knowledge relating to pharmaceutical development and design
of paediatric medicines.
An area of particular concern relates to paediatric
forms of products listed in the Essential Medicines List.
This includes antimalarial and tuberculosis products as well
as Fixed Dose Combination (FDC) products used in the
treatment of HIV/AIDS.
Given this background, a WHO Training
Workshop in Pharmaceutical Development with a focus on
pediatric medicine will be provided. Participants should be
from the Asian region, and should have qualifications and
experience in Regulatory Affairs, pharmaceutical development
and/or pharmaceutical manufacturing. The primary target
participant group will be pharmaceutical manufacturers, with
additional participation by personnel from National Medicine
The aims of the Training Workshop
To provide a forum for exchanging and
sharing information, knowledge and good practice in
developing, formulating and manufacturing paediatric
To deliver an instructional programme in suitable form
covering topics relevant to the course theme, ranging
from elementary physiology and paediatric
pharmacokinetics and toxicology, pre-formulation studies
and excipient properties and selection, to
manufacturing, scale-up, quality, regulatory and product
performance (bioavailability) and stability issues.
To provide a series of relevant, timely case studies in
the paediatric medicine field, with opportunities for
group discussion and feedback.
To discuss a WHO document that focuses on points to
consider in pharmaceutical development and paediatric
To encourage general debate between attendees and expert
instructors on issues raised during the course, and
discuss options for implementation of information
provided in the training programme.
To link, where possible, the instruction programme,
discussion sessions and case studies to the
implementation of the WHO prequalification