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
Related Links
eSubs and eCTD and RPA, Oh My!
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
