Agenda – 2nd eRegulatory Submissions Summit

We are presently in the process of creating the agenda for the 2nd eRegulatory Submissions Summit. If you’d like to be involved in developing this program or are interested in participating as a speaker or panelist at this conference, please contact Kelly Osmulski at

Topics under Consideration:

  • e-Regulatory Submissions in a small Pharma environment: outsource of in House
  • Understanding some of the challenges in moving to eDMS and eCTD
  • CRO Regulatory Operations/ Regulatory Affairs Submission Best Practices
  • IND Submissions, DMF Submissions Interactions, time to market Strategies
  • Lessons Learned from a small company transitioning to eCTD
  • eCTD specs being commented on to sponsors. Pharma cost controls, GDUFA, Abuse Deterrent drugs