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Drug Product Submission (NDS) Preparation in CTD and eCTD format Workshop
March 27, 2020 @ 9:00 am - 5:00 pm
How to prepare New Drug Submission (NDS) in eCTD format
The guidance on marketing applications for drugs and biologics was finalized by the International Council on Harmonization (ICH) in 2003. Today the CTD format is recommended for marketing applications in several countries in the world and is mandatory in several regions including Canada, Japan, Europe and U.S.A..
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 U.S., 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 will give participants the necessary overview of the Health Canada guidance documents for the preparation of a new Drug Submission (NDS) for Chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed and participants will work on a mock submission binder.
- Drug Development and NDS preparation
- Guidance Document: Preparation of Drug Regulatory Activities in the Common Technical Document (CTD) Format
- CTD Structure and Content
- Structure of Drug Regulatory Activities in the Common Technical Document (CTD) Format
- Module 1: Administrative and Product Information
- Module 2: Common Technical Document (CTD) Summaries
- Module 3: Quality
- Module 4: Nonclinical Study Reports
- Module 5: Clinical Study Reports
Certificate of Attendance and Course Material
- All participants will receive a certificate of attendance upon completion of the course.
- The participants will be receiving specially prepared course manual.