What Separates a Successful NDS from a Costly Delay

Level II goes beyond the basics, showing how to manage Modules 3–5, pre-submission meetings, and regulatory queries with confidence.

Greetings! In drug development, the step from foundational knowledge to advanced expertise often determines whether a submission advances smoothly through Health Canada or stalls in drawn-out correspondence. Level I built the structure. Level II now takes professionals deeper- into the preparation of New Drug Submissions in CTD and eCTD formats, with all their technical and procedural demands. This advanced workshop moves beyond concepts into the applied challenges of Modules 3, 4, and 5- where quality data, nonclinical findings, and clinical results must withstand scrutiny. It guides participants through the realities of pre-submission meetings, notices of deficiency and non-compliance, and the disciplined responses that protect timelines and credibility. It demonstrates how mastery of eCTD transforms regulatory interaction into an organized, efficient process rather than an administrative burden. Participants will not only gain clarity on advanced requirements but will also learn how to anticipate Health Canada’s expectations and avoid common pitfalls. Real-world case studies illustrate what separates successful submissions from costly setbacks. By the end, the process of structuring and defending a new drug submission will no longer appear uncertain- it will stand as a capability you can rely on. Date & Time Oct 10, 2025 3:00 PM - 5:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. 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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Hello, are you truly ready for GMP audits?

Learn more!

Greetings! Auditing contractors, vendors, and suppliers is not just a regulatory obligation - it is central to ensuring GMP compliance, safeguarding product integrity, and strengthening quality systems across external partnerships. Our Pharmaceutical Auditing Workshop offers a structured, practical framework for audit readiness. You will gain expertise in audit planning, execution, reporting, follow-up, and closure, while also addressing critical technical areas such as audits of classical chemical APIs, biological APIs, and dosage forms. Designed for QA professionals, auditors, and Qualified Persons (QP), the workshop delivers actionable insights through real-world case studies and interactive exercises. Led by seasoned industry experts, it equips you to conduct audits with confidence, mitigate compliance risks, and drive continuous improvement within your organization. Seats are limited and the deadline to register is approaching quickly. Secure your place today and ensure your teams and partners remain fully compliant and audit-ready. Date & Time Oct 2, 2025 1:00 PM - 3:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. 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

Register Now!

Discover the top events for you in our Weekly Event Guide GMP Audits, Inspections, Preparation and Management Oct 2 | 1:00 PM - 3:00 PM (EST) (Online) Drug Product Submission (NDS) Preparation in CTD & eCTD Format Workshop- Level 2 Oct 10 | 3:00 PM - 5:00 PM (EST) (Online) Drug Product Submission (NDS) Preparation in CTD & eCTD Format Workshop- Level 3 Oct 24 | 3:00 PM - 5:00 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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Hello, The FDA is rewriting the rules of clinical trials. Are you ready?

A free live workshop with Dr. Tigran Uzunyan on the FDA's blueprint for modern clinical development.

Greetings! The story begins with a familiar scene. A protocol is finalized, enrollment opens, and within weeks cracks appear. Recruitment slows, eligibility proves too narrow, and the data no longer reflects what regulators expect. What once passed as “good enough” now holds development back. The FDA has recognized this problem and issued new guidance. It is not a suggestion but a blueprint for change, pushing sponsors and CROs toward smarter, more inclusive, and evidence-driven trial models. To help navigate this shift, we are hosting a free live webinar: The Modern Clinical Trial: FDA’s Blueprint for Change. The session will be led by Dr. Tigran Uzunyan, a clinical research scientist with over eighteen years of experience in academia, industry, and regulatory-driven trial design. You will learn why outdated eligibility models are slowing enrollment, how PK/PD and clinical recovery can replace rigid calendar rules, and how risk-based approaches to concomitant medications create access without compromising safety. The discussion will also show how these strategies connect to decentralized trials and real-world evidence. The session concludes with a live Q&A. Attendance is free. Reserve your spot today and prepare to align with the FDA’s evolving expectations. Date & Time Oct 9, 2025 2:00 PM - 3:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. 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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Hello, are your audits truly GMP-ready?

Learn more!

Greetings! Auditing contractors, vendors, and suppliers is not just a regulatory obligation - it is central to ensuring GMP compliance, safeguarding product integrity, and strengthening quality systems across external partnerships. Our Pharmaceutical Auditing Workshop offers a structured, practical framework for audit readiness. You will gain expertise in audit planning, execution, reporting, follow-up, and closure, while also addressing critical technical areas such as audits of classical chemical APIs, biological APIs, and dosage forms. Designed for QA professionals, auditors, and Qualified Persons (QP), the workshop delivers actionable insights through real-world case studies and interactive exercises. Led by seasoned industry experts, it equips you to conduct audits with confidence, mitigate compliance risks, and drive continuous improvement within your organization. Seats are limited and the deadline to register is approaching quickly. Secure your place today and ensure your teams and partners remain fully compliant and audit-ready. Date & Time Oct 2, 2025 1:00 PM - 3:00 PM (EST) How is the Workshop delivered? Live. Virtual. Interactive. Instructor-led. REGISTER TODAY Interested in this workshop? Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

AAPS Pharma | 885 Sheppard Avenue West | Toronto, ON M3H 2T4 CA Unsubscribe | Update Profile | Constant Contact Data Notice