eRA Special Interest Network

eRA SPIN group

TOPRA eRA SPIN

Objectives

The TOPRA electronic Regulatory Affairs Special Interest Network (eRA-SPIN) was established in October 2007 to promote and promulgate e-Working and enable the transition within the industry to eCTDs. The mission of this group is to provide a vendor-neutral and independent source of collective information and shared ideas on e-document management (eDMS) and e-submissions and other areas of electronic Regulatory Affairs.

Advantages to Members

With over 100 members and growing rapidly, the activities of the group include:

  • providing a focus group for individuals from the pharma, biotech, medical device and veterinary industries to share experiences, discuss ideas and obtain advice on all areas of electronic working within Regulatory Affairs (including, but not limited to national e submissions, eCTD, PIM and document management)
  • enabling all industry companies represented to exchange information in a neutral environment with consultants and vendors
  • educating regulatory affairs professionals in both industry and the regulatory agencies

2008 Highlights

  • “Road-Map” of topics for presentation at regular meetings, providing a backbone of subjects within the eRA arena, about which members wanted to hear more
  • Parallel Session at TOPRA Annual Symposium
  • Joint TOPRA/ AGES PharmMed e-Working Meeting in Austria
  • Focus Issue of Regulatory Rapporteur

2009 Highlights

  • New 2009 and Beyond “Roadmap” for presentation topics
  • Working Party for joint AAPS/CMC/eRA SPIN meeting set up
  • First joint SPIN Group meeting with CMC SPIN in June
  • Parallel sessions at the Annual Symposium
  • Start-up work on new training programme for e-working in progress
  • Succession Planning for hand-over to new Steering Group at end of 2009

2010 Forecast

  • New Steering Group established January 2010
  • Focus Issue of Regulatory Rapporteur
  • New 2010 and Beyond “Roadmap” for presentation topics to be delivered throughout the year.
  • Parallel session at the Annual TOPRA Symposium in preparation
  • AAPS/CMC/eRA SPIN “e-Working Meeting 2010” Q2
  • Ongoing training programme for e-working - dates to be announced

Click here to access the eRA Members' Area.

Membership contact

eraspin@topra.org

e-network: TOPRAe-RANet

To become a TOPRA member please click here.