CONFERENCE SERIES: Clinical Trials & Translational Medicine
Recorded at: Summit for Clinical Ops Executives (SCOPE)
Digital Course: eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions
Digital Course: eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions
March 8, 2010
CHI’s Summit for Clinical Ops Executives (SCOPE) is made up of four annual conferences and short courses. By bringing these four events and three short courses together under the SCOPE umbrella, an opportunity for idea sharing and cross pollination amongst clinical operations professionals from different groups was created. Each conference remains autonomous and goes deeply into its own set of issues with its expert faculty. Each conference will feature best practice case studies and interactive discussions relevant to clinical operations experts as well as those new to the field.
About the Conference:
CHI’s Inaugural “eCTD 2010: Achieving Efficiency and Compliance in Electronic Submissions” was held March 10, 2010 at the Crowne Plaza Philadelphia City Center in Philadelphia, PA. Filing new submissions is time consuming and costly to both regulators and drug development organizations. Global regulatory agencies are committed to improving the approval process and the electronic Common Technical Document (eCTD) is seen as a practical solution. It has been mandated in some countries and, to date, over 30,000 eCTD sequences have been submitted to the FDA alone. Despite the promise of eCTD to move your data through the approval process more efficiently, there are challenges to adoption and implementation. This course will discuss how to achieve efficiency and compliance in electronic submissions.
How to Prepare Your Product Dossier for Global Simultaneous eCTD/CTD Submissions – A Look at Tools, Tips and Taking the Mystery Out of Submission Planning and Publishing
Meredith Sewell, Associate Director, Global Regulatory Affairs Publishing, Allergan, Inc.
Biography: Meredith K. Sewell holds a B.A. in English from University of California, Irvine. She began her BioPharm career at Amgen in Thousand Oaks, CA where she held various positions in the Regulatory Publishing group, as well as in the Finance & Corporate Communications Departments. In 1999, Meredith was responsible for helping lead Amgen into the electronic submission era, and they submitted their first fully electronic BLA that same year. Since then, Amgen continued to publish successful electronic submissions, including INDs, BLAs, NDAs, and eventually, eCTDs.
In March 2006, Meredith joined Allergan Inc. in Irvine, CA as Associate Director, Global Regulatory Affairs Publishing. Allergan submitted their first eCTD in July 2007 and has since submitted many other original product submissions, amendments and supplements as eCTDs. In 2009, Allergan successfully submitted several simultaneous global eCTD submissions to the US, Canada and the EMEA.
Prior to her electronic publishing and submissions career in the BioPharm Industry, Meredith worked in the aerospace industry publishing Airline Maintenance Manuals at a small technical publishing firm.
Case Study: Global Submission Management from Concept to Realization
Dominique Lagrave, Senior Director, Regulatory Operations and Innovations, Novo Nordisk
Biography: Dominique has over 10 years of experience in Regulatory Affairs and Regulatory Operations. Dominique began his career at Laboratoires Galderma in France, where he was a Regulatory Affairs Manager. In this position, Dominique led innovative programs to support electronic submissions in Venezuela and Australia. As a Regulatory Specialist for a leading submissions publishing vendor, Dominique consulted for over 20 companies worldwide assisting with their implementations of regulatory publishing tools and processes to support eCTD.
For the past 5 years, Dominique has been the head of the Regulatory Operations and Innovations group at Novo Nordisk, Inc. Dominique has given over 30 presentations at key conferences and webinars, and is a member of the PhRMA ERS group, eCTD subgroup and RPS working group. Dominique holds a Pharm D and a master’s degree in International Regulatory Affairs from the University of Paris.
Taking eCTDs off the Critical Path to Drug Development
S. Albert Edwards, Pharm.D., RAC, Director, Regulatory Operations, Takeda
Biography: Albert has spent more than 20 years in the food additive and pharmaceutical R&D business. This has followed other careers working for the US FDA, as a medical reviewer; the NIH, as a scientist; and four university settings as a teacher, researcher, and clinical pharmacist. He is a licensed pharmacist and was educated at the undergraduate and doctoral levels at the Universities of Illinois and Michigan, respectively.
He is the Director, Regulatory Affairs Operations, at Takeda Global Research & Development Center, Lake Forest, Illinois. From 1990 to 1999, Al supervised the filing of or personally filed FDA paper based submissions with 11 of CDER’s 15 drug review divisions. In 1996, he became the system owner for TAP Pharmaceutical’s e-submission system, and committed 50% of his time to fostering the e-submission paradigm. Al committed the other 50% of his time to electronic submissions in mid-2000; this followed two, large e-NDA filings in 1999. Today, post the TAP/Takeda integration, all submissions sent to the FDA utilize the electronic Common Technical Document [eCTD] format using a validated, electronic process for publishing submissions and managing documents. Over 1500 eCTD sequences have been filed with the FDA and other regulatory authorities.
He also has responsibility for Takeda’s Corporate Records Management Department. The records management program is electronic and complaint with FDA’s 21 CFR Part 11. The Department manages over 1 million electronic/paper records for Takeda.
Outside of the world of e-submissions and e-records, Al is a member of the Regulatory Affairs Professionals Society [RAPS] and was a member of the Regulatory Affairs Certification Board [RACB] for many years. Since 1993 he has been an active participant in the Regulatory Affairs Certification [RAC] process. In 1997, he received the RAPS Special Recognition Award for his efforts and commitment to the Certification process. In October of 2002, he was elected to serve on the RAPS Board of Directors as President-Elect in ’03, President in ’04, and Chairman of the Board in ’05. In 2006, RAPS recognized Al’s sustained achievements for the profession via the Richard E. Greco Award, RAPS highest award. In 2008, he was further recognized by being among the first to receive the RAPS ‘Fellows’ designation along with 26 other regulatory affairs practitioners from around the world.
The Regulatory Affairs Professionals Society (RAPS) is the leading worldwide member organization devoted to the health product regulatory profession, with more than 12,000 individual members from industry, government, research, clinical and academic organizations representing more than 50 countries worldwide.
Working with an eCTD Vendor: Best Practices and Lessons Learned
Thomas Noto, Vice President, Regulatory Affairs, Covance’s Periapproval Services
Biography: Thomas is Vice President of Regulatory Affairs for Covance Periapproval Services. He has over fourteen years of experience in Regulatory Affairs and has held senior management positions in several Contract Research Organizations. He has been responsible for the submission of over twenty marketing applications (including NDAs, BLAs and eCTDs) to the U.S. Food and Drug Administration; and has coordinated more than ten Investigational New Drug filings to the agency. He has also coordinated and conducted a variety of complex meetings between sponsors and the Agency and provided consulting support to sponsors on a wide range of regulatory issues. In addition, Thomas specializes in cutting-edge techniques and processes used in electronic publishing (including the electronic Common Technical Document format), and in document management and archiving activities. Thomas was instrumental in creating a group responsible for regulatory publishing services at his previous CRO where it became a key component of the total suite of regulatory services. Thomas also works across Commercialization to support joint CMA-Periapproval projects. Further, Thomas serves as our ambassador to the regulatory community within Covance. Thomas obtained his BA from Gettysburg College, Gettysburg, PA.
Electronic Signatures and Regulatory Processes, What the Agencies are Saying
Richard Furr, Head, Global Regulatory Affairs and Compliance, SAFE-BioPharma Association
Biography: Rich is the primary staff contact with the FDA and other global regulatory authorities. He provides staff support to a variety of SAFE-BioPharma working groups and manages the SAFE-BioPharma Product Certification Program. Prior to this position he was responsible for development of the association’s business policies, governance and compliance standards and regulatory compliance activities with the Food and Drug Administration.
Before SAFE-BioPharma, Rich worked with Churchill & Harriman, Strategic Identity Group and First Consulting Group. He also was Director, Strategic Plans for Aventis Pharmaceuticals Global Regulatory Affairs Operations. He served 20 years in the US Air Force as Signals Intelligence/Intelligence Staff Officer, Executive Officer and Squadron Commander. This included five years on the staff of the Assistant Chief of Staff, Intelligence. Upon leaving the military, he was a defense contractor managing the development of computer-based training programs for the USAF and US Navy.
Achieving Efficiency through Rounding Out Submission Standards: Format, Data, and Content Standards
Donald Palmer, RAC, Associate Director, Regulatory Systems, Regulatory Affairs, MedImmune, Inc.
Biography: Donald Palmer is an Associate Director of Regulatory Systems at MedImmune. Primary responsibilities include defining and participation in tactical and strategic Regulatory Affairs technology initiatives. These include electronic Submissions, electronic Document Management (EDM), Legacy Document Migration, and Lifecycle Management. Subject Matter Expert for electronic Submissions, submission EDM systems, and Regulatory information standards including Regulatory taxonomy and metadata standards expert on enterprise taxonomy and systems integration teams. He has over 20 years experience with regulatory and records management systems. MA in Math, Villanova; BA in Math, Earlham
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