Workshop Details


May 16, 2024


9:00 pm – 5:00 pm


CAD $625 + HST




May 9, 2024

Workshop Overview

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.

Who Should Attend​

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.

Workshop Outline

This workshop covers the following topics:

  • 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

Learning Outcomes

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.

All participants will receive a certificate of attendance upon completion of the workshop.

Drug Product Submission (NDS) Preparation in CTD and eCTD format Workshop

May 16, 2024

Other Workshops Available

Laleh Bighash

Pharma, Cannabis

Ms. Bighash has a Bachelor of Pharmacy, and a Bachelor degree in Pharmacology and Toxicology from University of Toronto, Canada. She also obtained her Masters degree in Business Administration (MBA) from Schulich School of Business. She is a recipient of 2019 UC-University of Toronto alumni of influence award and has been nominated for the Canadian Women Entrepreneur Award. In her current role as the President of AAPS, a post-graduate private college focusing on pharmaceutical and food higher education, she oversees the strategic, educational and training direction of AAPS. She has over 27 years of experience working for a number of multinational pharmaceutical companies such as Genpharm Inc., Bayer Corp. and Eli Lilly & Company. Laleh has also worked with a number of Food and Cannabis organizations in various capacities such as Research and Development, Quality Control, Quality Assurance, Regulatory and Compliance, Strategic Planning, and Business development.

Ms. Bighash has lectured extensively and has been an invited speaker at many global and Canadian academic and industry events focusing on pharma, food and cannabis-related topics such as regulatory, compliance and efficient operations. She has worked closely with the industry players and stakeholders in formulating efficient operating systems, ensuring regulatory compliance and certification.