Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The guidance on marketing applications for drugs and biologics, known as the Common Technical Document (CTD), was finalized by the International Conference on Harmonization (ICH) in 2003. Today the CTD format is highly recommended for marketing applications in the United States, and is mandatory in other regions, including Canada, Japan, and Europe.

The eCTD format has become mandatory in key markets for electronic submissions. Since January 2010, the European Medicines Agency has required all applications in the centralized procedure use the eCTD format. In the US, the eCTD format has become a requirement for all New Drug Applications, Biologics License Applications and Abbreviated New Drug Applications following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA). Further, the Generic Drug User Fee Act and Medical Device User Fee Act also impose mandatory electronic submissions to FDA.

This course, while focusing on the US requirements, also provides a quick overview of current regulatory guidelines of eCTD in major world market including North America, the European Union, and Asia-Pacific. It aims to introduce tools to assist the participants in formulating effective strategies in the development, compilation, and submission of US-compliant eCTDs. The structure of the eCTD, its content and granularity for the modules will be introduced, along with a review of the specifications, scope, requirements for the architecture and functionalities, as well as its impact on the pharmaceutical industry. .

Through practical workshop exercises, interactive discussions and real-life case studies, this training aims to provide useful tools for the participants to build eCTDs from the ground up. Advice on industry's best practice, as well as submission pitfalls from the reviewer's perspective will be introduced to help the participants in formulating the best strategies and employing the most practical tools to enhance the success of their electronic submissions.

Who Should Attend

This course is designed for professionals of the biotechnology and pharmaceutical industries who are currently, or planning to become, involved in the development of regulatory submissions using the electronic Common Technical Document (eCTD). The program is particularly suitable for project team members interested in gaining a practical understanding of regulations, tools, and required submission processes. This includes professionals working in:

• Regulatory Affairs / Regulatory Operations
• Submissions Management
• Authors of CTD Sections
• Technical and Clinical Writers
• Documentation Teams
• Project Management
• Information Technology and Information Systems

Wen Schroeder

Wen Schroeder is the founder and president of SEKI Cosmeticals. With 20+ years of industrial experience, 30 US patents and author of numerous publications, Ms. Schroeder is an internationally recognized lecturer on cosmetic science & regulatory affairs.

Her lecture topics cover a wide range of areas including chemical management and biocide regulations, food, drug and cosmetic law. She is a key expert for numerous cross-governmental aid programs including the ASEAN-EU Programme, under the European Commission, for Regional Integration Support in cosmetic & pharmaceutical GMP and testing. Ms. Schroeder is scientific advisor to Taiwan External Trade Development Council and previously taught courses addressing cosmetics, food, OTC drugs, biocides and chemical management topics. She served on the Personal Care Products Council and is active in the Society of Cosmetic Chemists and the Regulatory Affairs Professional Society.

Ms. Schroeder is the editor of a newly published book, Sustainable Cosmetic Product Development by Allured Books, which is the first comprehensive technical reference work in this field for the cosmetic and personal care industry.