Regulatory Update

Oct 26, 2015
On September 14th the EFSI/PSI regulatory committee met face-to-face with MHRA statisticians in London for a two hour meeting.  First a discussion was held on follow up activities regarding topics discussed at previous meetings, in particular the efforts to develop best practices for modelling and simulation (which were presented at the 2015 PSI Conference by the Modelling & Simulation Special Interest Group), and on the valuable efforts by PSI to reach out to Small and Medium Enterprises (SMEs) to increase awareness of key statistical principles fundamental to drug development and how SMEs can seek statistical advice.   Other topics discussed included subgroup analyses; post-authorisation efficacy studies; methods for dose response evaluation; recent experiences of parallel scientific advice involving regulators and/or payers; data transparency; use of Bayesian approaches in confirmatory trials; comparison between Europe and US of initiatives aimed to accelerate the development of promising new medicines and biosimilars.
On October 9th the committee met with EMA's Biostatistics working party.