|Articles|April 1, 2009

Podcast Series- eCTD

eCTD: Learn from Early Adopters

Implementation of the electronic Common Technical Document or eCTD is still early on the adoption curve within the pharmaceutical industry. Regulatory professionals will be interested to hear the insights from participants of an eCTD Early Adopters Roundtable sponsored by Applied Clinical Trials and Clarkston Consulting.

Get Comfortable Moving from Paper to Electronic
Quintiles’ Laurie Henricks tells us how-in her CRO capacity-she coaches sponsor/clients to get more comfortable with moving from paper submissions to electronic submissions.

Challenges to eCTD
Janel Firestein, our roundtable moderator, offers her take on the expert discussion and the major challenge she sees to eCTD implementation.

Bringing in an Objective Outsider
Michael J. McGraw, PharmD, MS, regulatory affairs manager at Teva Neuroscience, discusses the benefits of bringing in an objective outsider.

Training Employees on eCTD
Shire Pharmaceuticals’ Carol Rutkowski, Senior Director, Global Regulatory Operations, Shire explains the benefits of training employees in regard to the regulatory eCTD submissions world.

Pilot Testing eCTD Software
Veteran regulatory affairs professional Dr. Albert Edwards, PharmD, RAC, Director, Regulatory Operations, Takeda offers his views for eCTD implementation in the future