Getting your ducks in a row: Successful Management of Large eCTD Submissions
Original Air Date: Wednesday, November 6, 2019
Time: 10 am (EST) | 7 am (PST) | 3 pm (CET)
Once gap-analysis of your marketing or investigational new drug application has been completed, Cato Research recommends that planning for the submission of the eCTD application begin. While many companies treat the actual compilation and submission of the application as an afterthought, the activities involved are numerous, complex, and interrelated. The activities must be well orchestrated, as there is no simple button to push. Cato Research’s experience reveals that detailed planning and management leads to a successful eCTD submission.
A CATO senior regulatory submissions specialist will be joined by a senior regulatory scientist and project manager to discuss the successful planning, organization, and management of marketing applications. Cato Research’s experience with applications both large and larger will inform the discussion. Pitfalls, lessons learned, and case studies will be included.
Webinar Key benefits for you:
- Understand the range of scope and complexity of large eCTD submissions
- Identify and prevent common pitfalls
- Discover planning and organizational tools to avoid delays
- Learn from successful case studies
About the Presenters
Margaret Schubert, B.A., RAC
Senior Regulatory Submission Specialist
Ms. Schubert has 18 years’ experience in drug development. Before coming to Cato Research she was an assistant clinical trial material project manager for Trimeris, Inc., where she assumed increasing levels of responsibility for the management of clinical trial materials for all clinical trials. For the last 3 years of her tenure at that company, she was solely responsible for these activities. At Cato Research, Ms. Schubert joined the Pharmaceutical Development group and has built upon her previous training and experience and continued to expand her knowledge base of Good Manufacturing Practice (GMP), new regulations for the European Union and Canada, and technical issues. She has been certified as a GMP auditor through the International Society for Pharmaceutical Engineering. Ms. Schubert has assumed primary responsibility for management of clinical trial materials for Pharmaceutical Development activities for a variety of clients. With the Regulatory Operations group at Cato Research, she has attained Regulatory Affairs Certification for the United States (R.A.C. [U.S.]) and, since 2016, has primary responsibility for more than 300 electronic regulatory submissions each year. Ms. Schubert has also assumed increasing responsibilities in the Quality Assurance group over the past 6 years, including document quality control reviews, internal audits, and hosting client audits of Cato Research.
Michelle Villasmil, Ph.D., RAC
Assistant Director, Regulatory Strategy, Pharmaceutics
Dr. Villasmil has more than 16 years’ experience in biological research, with extensive experience in molecular biology, cell biology, and regenerative biology. As a scientist at Cato Research, Dr. Villasmil has many responsibilities, including management of regulatory submissions to the FDA; acting as a regulatory contact for interactions with the FDA; writing and reviewing regulatory, clinical, and scientific documents; assisting with clinical trial management and pharmaceutical development; management of regulatory projects (e.g., INDs, NDAs, BLAs, ANDAs); providing scientific consulting; and assisting with the preparation of strategic development plans. She has gained project experience in therapeutic areas such as infectious diseases, oncology, regenerative medicine, and cardiology. Dr. Villasmil also manages the daily operations of the Cato Research Fellows Department.