It is 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 Regulatory Authorities.
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 medicines.
-
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 formulations.
-
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 programme.