Positions of industry responsibility held

Global Programmes

Rapporteur
for M2 Expert Working Group at ICH – eCTD and other electronic interchange standards
2006 – 2010
EFPIA Topic Leader
for M2 at ICH – eCTD and other electronic interchange standards
2002 – 2010
EFPIA Deputy Topic Leader
for M2 at ICH – eCTD and other electronic interchange standards
1998 – 2002
EFPIA Expert
for M5 at ICH – Identification of Medicinal Products
2010 – 2011
Member of ISO Technical Committee 215, Working Group 6 – Standards body dealing with the development of the standard for Individual Case Safety Report and Identification of Medicinal Products 2007 – 2013
Topic Group Leader
for IDMP at for the IRISS Forum
2012 – present

European Programmes

Member of EFPIA Telematics Working Group
– Committee dealing with regulatory information management
2010
Member of EFPIA PRIMAG
– Committee dealing with regulatory information management
1998 – 2010
PRIMAG Representative
to EFPIA Regulatory Affairs AHG – Committee dealing with regulatory affairs business
2004 – 2007
EFPIA Representative
to PhRMA Electronic Records and Systems Committee – Committee dealing with electronic submissions in the USA
2006 – 2008
Member of EFPIA eCTD Topic Group
– working group supporting eCTD implementation
2005 – 2010
EFPIA eCTD Topic Group Leader
– working group supporting eCTD implementation
2002 – 2005
Industry Business Leader
for the PIM project – EMA/EFPIA project to transition to XML-based Product Information. Co-Chair of PIM Steering Committee
1999 – 2010
EFPIA PIM Topic Group Leader
– working group supporting PIM implementation
2005 – 2010
EFPIA Representative
on Telematics Implementation Group-electronic submissions (TIGes) – Industry/Agency body involved with e-submissions implementation activities in Europe
2002 – 2010
EFPIA Representative
on Interlinking Group – a subgroup of the TIGes and the Notice to Applicants Group responsible for proposing modifications to guidance for applicants in support of e-submissions
2005 – 2010
EFPIA Representative
to the European Union Review System (EURS) Working Group – EMEA-led project to define and implement a review tool for eCTDs across the EU
2005 – 2008
EFPIA Representative
on Eudravigilance Expert Working Group – Industry/Agency body dealing with pharmacovigilance matters, specifically issues associated with the Individual Case Safety Report and Identification of Medicinal Products
2009 – 2011

National Programmes

Member of the UK MHRA Sentinel Project advisory group
– project to transition all interactions between industry and agency to electronic processes
2004 – 2005
Industry Representative
on SwissMedic project to implement e-submissions
2009 – 2010
Member of BSI IST/35 Committee, the UK mirror panel for ISO TC 215 2009 – 2013
Member US PhRMA Electronic Regulatory Submissions Committee
- Liaison representative from EFPIA PRIMAG
2006 – 2009