Anvisa will promote, on 26/11, a Sector Dialogue to debate the Public Consultations (CPs) 685, 686 and 687, which deal with the new regulations of stability and post-registration of biological products. The event will be held in the auditorium of the Agency's headquarters, in Brasilia (DF), from 9:30 to 17h.
The purpose of the meeting is to discuss with companies, associations, entities that represent the manufacturers of organic products and interested parties the contributions received during the respective PCs, for a better understanding and improvement of the proposals.
Those interested in participating in the Sector Dialogue must register through a specific form, which requires five mandatory information: name, email, organization to which it belongs, position and telephone.
About CPs
CP 685: Proposed initiative for revision of RDC 50/2011, which provides for stability studies of biological products.
CP 686: Proposal for a complementary initiative for the revision of RDC 49/2011, which deals with post-registration changes to biological products.
CP 687: Proposed initiative for revision of RDC 49/2011, which provides for post-registration changes to biological products.
Sector Dialogue and CP
Both sectoral dialogues and public consultations represent valuable tools for broadening social participation. Sectoral dialogues are face-to-face or virtual meetings that bring together specific audiences to debate and exchange information during one stage of the regulatory process. Depending on the need, various sectoral dialogues can be held. Public consultations, on the other hand, offer citizens, social entities and representatives of the regulated sector the opportunity to participate in the construction of regulatory norms.
Source: http://portal.anvisa.gov.br/noticias/-/asset_publisher/FXrpx9qY7FbU/content/pos-registro-de-produtos-biologicos-debate-em-26-11/219201?p_p_auth=tQoNDDBZ&inheritRedirect=false&redirect=http%3A%2F%2Fportal.anvisa.gov.br%2Fnoticias%3Fp_p_auth%3DtQoNDDBZ%26p_p_id%3D101_INSTANCE_FXrpx9qY7FbU%26p_p_lifecycle%3D0%26p_p_state%3Dnormal%26p_p_mode%3Dview%26p_p_col_id%3D_118_INSTANCE_KzfwbqagUNdE__column-1%26p_p_col_count%3D1