In 2003, the International Council on Harmonization (ICH) finalized guidance on marketing applications for drugs and biologics. Today, the Common Technical Document (CTD) format, recommended by ICH, is indispensable for marketing applications across various global jurisdictions, including mandatory use in regions such as Canada, Japan, Europe, and the U.S.A. Furthermore, the electronic Common Technical Document (eCTD) format has emerged as a necessity in key markets for electronic submissions, with mandatory adoption in several regions. Since January 2010, the European Medicines Agency mandated the use of eCTD for all applications in the centralized procedure, while in the U.S., following the 2012 reauthorization/update of the Prescription Drug User Fee Act (PDUFA), eCTD became obligatory for New Drug Applications, Biologics License Applications, and Abbreviated New Drug Applications. Additionally, the Generic Drug User Fee Act and Medical Device User Fee Act enforce mandatory electronic submissions to the FDA. This workshop offers participants a comprehensive overview of Health Canada's guidance documents for preparing new Drug Submissions (NDS) encompassing Chemical drugs, biologicals, biopharmaceuticals, biosimilars, and chemical generics. Through analysis and discussion of significant areas such as Chemistry Manufacturing and Controls (CMC), Nonclinical, and Clinical aspects within the ICH CTD module format, attendees will gain insights and practical experience by working on a mock submission binder.
This workshop is tailored for individuals involved in regulatory affairs, quality assurance, product development, laboratory operations, manufacturing, and clinical development within the pharmaceutical and allied industries. It is designed for regulatory affairs professionals, quality assurance personnel, product development teams, laboratory staff, manufacturing personnel, and clinical development teams. Additionally, it caters to internal and external auditors tasked with conducting audits on suppliers and internal processes. This workshop is especially beneficial for Qualified Persons (QP) seeking to enhance their auditing proficiency and anyone requiring a comprehensive understanding of industry standards for auditing within the pharmaceutical and allied sectors.
This workshop covers the following topics:
NDS Submission Essentials
Acquire a comprehensive understanding of the essential elements and requirements for preparing a new Drug Submission (NDS) in both Common Technical Document (CTD) and electronic Common Technical Document (eCTD) formats, including regulatory guidelines, documentation standards, and submission processes.
CTD Module Proficiency
Develop proficiency in navigating and utilizing the structure and content requirements of the CTD modules, encompassing Chemistry Manufacturing and Controls (CMC), Nonclinical, and Clinical sections, to ensure comprehensive and compliant NDS submissions.
eCTD Implementation Mastery
Master the intricacies of electronic submission using the eCTD format, including understanding regulatory agency requirements, preparing electronic submissions, validating submission documents, and ensuring compliance with electronic submission guidelines.
Practical Submission Preparation
Apply theoretical knowledge through hands-on exercises and practical case studies to prepare a mock NDS submission binder in both CTD and eCTD formats, gaining valuable experience in assembling, organizing, and presenting submission documents effectively.
Note: Registration closes one week prior to the start of workshop.
