New to Regulatory Affairs? Start with the NDS Process

Understand drug development, CTD/eCTD and the submission pathway. Save 20% when you register by August 14.

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! Getting a new drug to market requires more than promising science. It requires navigating a complex regulatory pathway from development through submission and approval.  This introductory workshop breaks down the fundamentals of Regulatory Affairs and the New Drug Submission (NDS) process, including how to: Understand the drug development and approval pathway Navigate the key components of a New Drug Submission Understand notice types, priority review, and pre-submission meetings Structure submissions using the Common Technical Document (CTD) Understand submission formatting, filing, screening, and the advantages of eCTD Whether you're entering Regulatory Affairs or looking to strengthen your foundational knowledge, this session provides a practical overview of how drug submissions move through the regulatory process.  Early Bird Offer: Register by August 14 and use code SAVE20 to receive 20% off your registration.  *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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Your Weekly Event Guide: Expand Your Learnings and Discover Exciting Opportunities

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Discover the top events for you in our Weekly Event Guide Future-Proofing Clinical Trials: Essential GCP Updates You Need to Know Aug 13 | 1:00 PM - 2:00 PM (EST) (Online) SOPs That Work: Why Most Procedures Fail in Practice Aug 20 | 12:30 PM - 3:30 PM (EST) (Online) NDS Submissions Explained: Where Applications Break Down Sep 10 | 2:00 PM - 4:00 PM (EST) (Online) Are you ready to expand your learnings? Broaden your knowledge and delve into new horizons with AAPS! LEARN MORE!

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Beyond Compliance: Improving Trial Quality

Better Compliance. Better Trials.

Future-Proofing Clinical Trials: Essential GCP Updates You Need to Know Date & Time Aug 13, 2026 1:00 PM - 2:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. Greetings! The updates introduced in ICH E6(R3) are about more than regulatory compliance. They are designed to improve how clinical trials are conducted from start to finish. During this workshop, you'll explore how modern approaches can help organizations: • Improve trial efficiency through risk-based methodologies • Enhance participant engagement and retention • Strengthen data quality and integrity • Reduce unnecessary operational burden Through practical examples and case studies, you'll learn how these principles can be applied to real-world clinical research settings. The future of clinical trials is already here.  *All participants will receive a certificate of attendance upon completion of the workshop. 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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GMP in Practice: Are You Ready for an Inspection?

Save 20% when you register by August 13.

Date & Time Sep 17, 2026 2:00 PM - 4:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. GMP in Practice: What Inspections Expect for 2026 Greetings! GMP compliance goes far beyond having the right procedures in place. From documentation and production controls to deviations, validation, training, and change control, inspectors expect organizations to demonstrate that their quality systems are not only documented, but consistently followed in practice.  This practical workshop explores the essential elements of GMP compliance and inspection readiness, including how to:  Strengthen quality systems across pharmaceutical operations Maintain effective GMP documentation and accurate records Manage deviations, specifications, validation, and change control Apply production and quality controls that support consistent product quality Prepare teams and systems for regulatory inspections and audits  You'll gain a practical understanding of how GMP principles translate into everyday operations and what organizations should be prepared to demonstrate when inspectors arrive.  Early Bird Offer: Register by August 13 and use code SAVE20 to receive 20% off your registration.  *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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