For over quarter of a century, the bioanalytical community, alongside regulators, has been very active in defining the procedures and specifications for bioanalysis to allow generation of high quality data in a consistent manner. These efforts have led to a set of standards that are used in multiple global regulatory guidance around the world. The problem with this is that having multiple guidance results in variations in the substance, or the interpretation, of these standards. For the last 6-7 years bioanalysts have struggled with these differences since the data generated by a typical bioanalytical laboratory is submitted, to not only the local regulatory agency, but also to multiple regulatory agencies around the world. When ICH announced in June 2016 it would take up the topic of BMV for harmonization as ICH M10, the bioanalytical community became highly encouraged that one ICH guidance would increase efficiency by removing redundancy and conflicts. This workshop will provide a venue for the bioanalytical community to continue their decade-long efforts toward creating a globally harmonized guidance.
Goals and Objectives:
Similar to previous Crystal City Bioanalytical Workshops, this workshop will provide an opportunity for bioanalytical practitioners and regulators to discuss where current global guidance are out of sync and in need for harmonization. In multiple interactive sessions the workshop will review the extent and scope of validation required through various stages of drug development and its application to routine samples analysis. All stakeholders whose work would be affected by this guidance are urged provide our voice and collective input to the ICH working committee while the discussions on M10 continue. The agenda for this workshop is a collaboration with European Bioanalysis Forum (EBF) and Japan Bioanalysis Forum (JBF). A sister meeting in Europe is being organized by EBF (September 24—26, 2017, Lisbon, Portugal).
Who Should Attend
Scientists, regulators, and quality assurance experts involved in bioanalytical science as well as bioanalytical laboratory managers and supervisors.