Immunization standards

DCVRN NEWS

The 14th DCVRN Meeting will be held from 24 to 28 November 2013, in Tehran, Islamic Republic of Iran.

Meeting topics include:

  • the polio eradication endgame;
  • cost effective analysis for the introduction of rotavirus vaccine (Islamic Republic of Iran as a case study);
  • regulation of needle-free devices for immunization;
  • surrogate clinical endpoints for non-polysaccharide pneumococcal vaccines, and surrogate markers of immunogenicity with new protein based vaccines;
  • clinical requirements for the licensure of new L1 VLPs-based HPV vaccines. Bridging the gap between already licensed vaccines and new generation of HPV vaccines;
  • report on various dengue vaccine meetings;
  • report on a global expert consultation on the use of placebo in clinical trials;
  • need of clinical evidence for the approval of manufacturing changes (post licensure, during clinical development plan);
  • update on WHO guidelines / recommendations on regulations for the evaluation of vaccines;
  • report by country members of the network.

Delegations will also explore and discuss the possibility of harmonizing procedures and templates for the evaluation of clinical trials. In this context, the experience of an African sister network, the African Vaccine Regulatory Forum (AVAREF), will be considered.

Another topic for discussion that is considered to be relevant for the future development of the network is the potential expansion to medicinal products other than vaccines. So far, the network provides a forum for discussion, advancement of knowledge and exposure to policies and procedures pertaining to regulatory oversight during the clinical development of vaccines, authorization and inspection of clinical trials, evaluation of investigational products and evaluation of registration dossiers.

This year’s meeting will be characterized by the election of a new chairperson.

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Last update:

20 November 2013 15:17 CET