E-DRUG: "Pharmaceutical Development with Focus on Paediatric Formulations" Workshop
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[To respond DO NOT CLICK REPLY, contact Mrs Patricia Demolis at demolisp@who.int ]
Second Announcement
Dear colleagues,
The WHO Prequalification of Medicines Programme (PQP) in cooperation with the Singapore Health Sciences Authority (HSA), will be holding a training “Pharmaceutical Development with a Focus on Paediatric Formulations”, which will take place in Singapore from 27 February to 1 March 2012.
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 paediatric 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.
For a detailed programme kindly visit the Programme’s website at http://www.who.int/prequal/trainingresources/Training_Singapore_February2012.htm
For further information regarding participation at the workshop, kindly contact Mrs Patricia Demolis at demolisp@who.int.
With our best regards,
WHO Prequalification of Medicines Programme
Samvel Azatyan M.D., Ph.D. | Manager, Medicines Regulatory Support Programme [MRS]
Quality Assurance and Safety: Medicines
Department of Essential Medicines and Pharmaceutical Policies (EMP)
World Health Organization
20, Avenue Appia, CH-1211, Geneva 27, Switzerland
Direct phone: +41 22 791 1506 | Fax: +4122 791 4167
http://www.who.int/medicines/en/
E-mail: azatyans@who.int