Understand What Goes Into a New Drug Submission

From drug development to CTD and eCTD, build your foundation in the regulatory submission process.

Date & Time Sep 10, 2026 2:00 PM - 4:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. NDS Submissions Explained: Where Applications Break Down Greetings! Every new drug approval begins with understanding the regulatory pathway. From drug development and pre-submission meetings to CTD preparation, filing and regulatory review, bringing a new drug to market involves a structured process with specific requirements at every stage. This workshop provides a practical introduction to that process and the regulatory framework behind it. Participants will explore: How the drug development and approval process works The fundamentals of New Drug Submissions (NDS) Notice types and Health Canada’s Priority Review Policy The role of pre-submission meetings Submission formatting, filing and screening The structure and purpose of the Common Technical Document (CTD) Key CTD modules and their role in a submission How eCTD can streamline the regulatory submission process Designed for professionals entering Regulatory Affairs, as well as those in Quality, Drug Development and the pharmaceutical industry who want to strengthen their understanding of the submission and approval process. Build the regulatory foundation behind successful drug submissions.  *All participants will receive a Certificate of Attendance upon completion. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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When an NDS Gets More Complex

Build practical skills for advanced CTD and eCTD preparation, lifecycle management, and regulatory responses.

Date & Time Oct 1, 2026 2:00 PM - 4:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. NDS Level 2: Practical CTD and eCTD Preparation for Drug Product Submissions Greetings! Knowing the CTD structure is one thing. Managing a complex submission is another. As an NDS moves through preparation and review, regulatory professionals need to connect quality, nonclinical and clinical documentation, manage the eCTD lifecycle, and respond effectively when Health Canada raises questions or deficiencies. NDS Level 2: Practical CTD and eCTD Preparation for Drug Product Submissions takes participants beyond the fundamentals and into the practical challenges involved in preparing and managing advanced drug submissions. Through detailed instruction and real-world case studies, participants will learn how to: Prepare advanced content across CTD Modules 3, 4 and 5 Manage quality, nonclinical and clinical documentation Navigate pre-submission meetings with Health Canada Respond to NODs, NONs and regulatory queries Manage eCTD amendments and submission lifecycles Apply effective cross-referencing, hyperlinking and filing practices Recognize common challenges through real-world NDS case studies Ideal for Regulatory Affairs, Quality, Clinical Research and pharmaceutical professionals who already understand the fundamentals and are ready to develop more advanced, practical submission skills. Move beyond understanding the submission. Learn how to manage it. *All participants will receive a Certificate of Attendance upon completion. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

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Last Day: 50% Off All Recorded Webinars

Explore 35+ specialized sessions led by experienced industry professionals.

Experience Across the Industry Practical Industry Knowledge, Led by Experienced Professionals  Professional development is most valuable when it is grounded in the realities of the work.  AAPS Pharma’s recorded webinar collection brings together experienced professionals to provide focused training across Regulatory Affairs, Quality Assurance, GMP, Quality Control, Clinical Research, Pharmacovigilance, Food and Cannabis.  The collection covers subjects ranging from NDS preparation, CMC and medical device regulation to CAPA, SOPs, HPLC, pharmacovigilance, GCP, OOS investigations and Quality by Design, with each session focused on the processes, standards and regulatory considerations that shape work across regulated industries.   Recorded sessions are available on demand, allowing professionals to work through technical material at their own pace and return to it when needed. Participants also receive a certificate of completion. Through August 31, all recorded webinars are available at 50% off with code SUMMER50   Explore the recorded webinar collection by area of practice.   REGULATORY Regulatory Strategy - Medical Devices and other Health Technologies Chemistry, Manufacturing and Controls (CMC) Training Drug Product Submission (NDS) in CTD and eCTD Format Workshop - Level 1 Drug Product Submission (NDS) in CTD and eCTD Format Workshop - Level 2 Drug Product Submission (NDS) in CTD and eCTD Format Workshop - Level 3 Bringing Medical Devices to Market in Canada: Understanding the Regulatory Pathway Natural Health Products (NHPs) Level 1 Natural Health Products (NHPs) Level 2 Natural Health Products (NHPs) Level 3 QUALITY ASSURANCE Developing an Effective CAPA Strategy Mastering Key Concepts in Cold Chain Management Computer System Validation Data Integrity Key-considerations Drug Safety and Adverse Reaction Reporting Workshop Lean for Root Cause Analysis and Corrective Action Path GMP Compliant Temperature Mapping Annual Product Quality Reviews (APQRs) GMP Audits, Inspections, Preparation and Management HPLC Testing - Accelerated Annual GMP Masterclass Navigating the USP: Practical Guidance for QA. QC and Industry Professionals SOP Masterclass: Writing Effective Standard Operating Procedures GMP Compliance Masterclass: Auditing HPLC Data Mastering Batch Record Review - Level 1 Mastering Batch Record Review - Level 2 CLINICAL RESEARCH AND PHARMACOVIGILANCE Introduction to Drug Safety Pharmacovigilance Regulations and Good Pharmacovigilance Practices Future-proofing Clinical Trials: Essential GCP Updates You Need To Know QUALITY CONTROL OOS Investigations For Testing Laboratories in a GMP Environment Optimization of a Pharmaceutical Granulation Process Using Quality by Design (QbD) Fundamentals of Formulation and Manufacturing HPLC Online Certification CANNABIS Cannabis Tissue Culture Quality Assurance for Cannabis: QAP Roles and Responsibilities Review of the Cannabis Act Continue Building Your Industry Knowledge Whether you are developing expertise within your current area of practice or building familiarity with another part of the regulated industry, the recorded webinar collection provides access to focused training from professionals with direct industry experience. Sessions are available on demand and include a certificate of completion. Use code SUMMER50 to receive 50% off all recorded webinars through August 31. Browse the Recorded Webinar Library Interested to know more about AAPS Pharma? To learn more, call our team at 416-628-7575 or visit us at events@aapspharma.com

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