15 - 16 June 2017 - Prague, Czech Republic

The inaugural DIA Workshop on Benefit-Risk Strategy took place in Prague, Czech Republic on 15 - 16 June 2017. Dr Steve Mayall, Principal Consultant at Pope Woodhead, was a member of the programme committee and he also chaired and presented in two of the seven sessions during this two-day event.

Leading benefit-risk experts from industry, EMA, MHRA, BfArM and HPRA shared their knowledge on both a strategic and practical level during this interactive workshop. The first day was dedicated to benefit-risk assessment and kicked off with a well-received keynote address by Francesco Pignatti from EMA. The second day covered other high-profile benefit-risk topics including the update to GVP Module V on Risk Management Systems, PRAC referrals and the use of digital approaches in risk management.

Steve chaired and presented in two sessions focusing on structured benefit-risk assessment. The first covered evolving benefit-risk assessment requirements and initiatives, which benefitted from the experience of two speakers from the ICH M4E(R2) Expert Working Group. His second session addressed the implications of performing assessments for organisations and data collection, which included two speakers closely involved in the IMI PROTECT Work Package 5 initiative.

The workshop was a useful opportunity to gain the latest perspectives from experts in the field, and should help participants to perform benefit-risk management more effectively within their organisation.

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