Sucesso de IQ na ANVISA!
May 21, 2018
Sucesso de IQ na ANVISA!
IQ DruSafe conducted a workshop on ICH multidisciplinary and safety guidelines at ANVISA, the Brazilian Health Surveillance Agency in Brasilia on 22-23 March 2018. ANVISA is new memebr of ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) and the workshop fulfilled a key ICH training objective for new members.
Organized by the DruSafe Chair Emeriti (Michael Graziano, Bristol-Myers Squibb; Kerry Blanchard, Merck & Co.; John Burkhart, Pfizer; Vivek Kadambi, Blueprint Medicines), the workshop’s goal was to give ANVISA pharmacology and toxicology reviewers a better understanding of ICH guidances. The following topics were covered: M3, including dose selection for clinical trials; S9; S6 including species selection; M7; S5, including alternative approaches; and S1. In addition, a presentation on Approaches for Rare Diseases and Severely Debilitating or Life-Threatening Diseases was also discussed. Participants and speakers also spent time in breakout groups discussing relevant case studies to gain a greater appreciation of how to interpret and apply the guidances in real world situations. Each DruSafe speaker was selected for his/her expertise in drug development, and several of the speakers were members of the ICH Expert Working Groups that developed the guidelines.
More than 40 staff from ANVISA attended over the 2 days and, based on the level of participation and engagement, the workshop clearly met its objectives. The workshop also further established IQ DruSafe as a credible, authoritative, and cooperative partner in preclinical drug development that is willing to share its collective knowledge and extend its global outreach.
For additional information on this workshop, please contact the IQ Secretariat (info@iqconsortium.org).