First draft of whitepaper

The draft whitepaper will propose a catalogue of information requirements and needs for harmonisation (e.g. to address borderline products that fall under different legislature in different world regions). It will propose a gap analysis, where scientific state of the art and regulatory practice seem out of step (e.g. present a list of major adversities of administered NBMs described in the scientific literature, that are hard to predict by current standard testing methods). Thirdly the document will propose a heuristic how to assimilate new evidence in reliable and efficient way into regulatory strategies (e.g. which testing methods would deliver information that supports the modeling of an NMB-specific Adverse Outcome Pathway, for example for CARPA ).