The WHO vaccine position papers, available in English, French, Arabic, Chinese, Russian

and Spanish, summarize the recommendations of SAGE and serve as key reference documents. [6] Comments from vaccine manufacturers to the position papers are sought through e-consultations, while aware of potential conflicts of interest and equity. SAGE has also provided guidance to vaccination in humanitarian emergencies, based on assessment of the epidemiological risk, vaccine characteristics, and prioritization in the context of other urgent public health needs and security, financial, and political realities. New SAGE working groups will be formed to review evidence leading to updating recommendations on the use of Japanese EPZ5676 encephalitis,

pertussis, varicella, hepatitis E, and malaria vaccines among others. N. Dellepiane gave updated information on WHO Prequalification (PQ) procedures, focusing on the strategic priorities, including securing the supply base for priority vaccines for developing countries, facilitating access to quality products, improving efficiency of the prequalification procedure and to expanding portfolio for vaccine introduction. Related activities were conducted including the amendment of several WHO guidance documents [7], [8], [9], [10], [11], [12], [13], [14] and [15], the implementation of expedited/facilitated registration procedure for prequalified vaccines in receiving countries, Gefitinib in vitro and two WHO workshops in China and India targeting at manufacturers with potential for PQ of priority vaccines. In 2013, already an Internet based tool has been developed and hosted on WHO-server

for online submission, processing and monitoring of registration applications. She introduced the features of the revised procedure, notably, the Programmatic Suitability of Product Characteristics (PSPQ) committee, the streamlined prequalification procedure of 6 months for manufacturers in countries with eligible authorities, and the establishment of annual reporting systems (PQVARs). Finally, a customers’ survey was made of PQ service design (PQ process) and service delivery. Still, there are concerns about overall time required for prequalification and process time inefficiencies (e.g. overall elapsed time, knowing when to expect a response). Manufacturers would like to see samples tested in parallel to the review of the file, while this may not be feasible to implement. In addition, there is a need for harmonization of expectations between different GMP auditors, categorization of deviations and of GMP code applied. This year the first open Chief Executive Officers (CEOs) Panel Discussion held at an annual general meeting was moderated by H. Dabas, from the Clinton Health Access Initiative (CHAI). CEOs from 9 DCVMN member companies discussed how to turning challenges into opportunities. A.