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 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) Advanced Strategies for the FDA's Modern Clinical Trial Framework Oct 23 | 1:00 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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Hello, Clinical trials are changing. Are you?

FDA's new framework demands more than compliance… it demands smarter, inclusive, patient-centric designs.

Greetings! Most clinical trials are still stuck in the past… built on restrictive designs that slow enrollment, exclude real patients, and waste years chasing data that regulators no longer find convincing. The FDA has made it clear: the old way of writing protocols and running studies is not enough anymore. This masterclass takes you inside the new framework. It’s not theory… it’s a practical walk through how to move from outdated rules to modern, inclusive, patient-centric trials. You’ll see how to replace rigid eligibility criteria with defensible language, how to use decentralized components and real-world evidence to expand reach, and how to run operations and QA in a way that avoids busywork while staying fully compliant. The goal is simple… smarter trials that regulators trust and patients actually benefit from. Leading the session is Dr. Tigran Uzunyan, a medical doctor and research scientist with nearly two decades of experience in clinical development. From early-phase studies and bioequivalence trials to large late-phase programs across multiple jurisdictions, he has seen where traditional models fail and how modern strategies succeed. His work spans everything from pharmacology research to medical cannabis development in Canada, making his perspective both global and deeply practical. If you are responsible for trial design, operations, QA, or regulatory strategy, this session will give you what you need to move beyond the checklists and into the real future of clinical trials. The question is… are you ready to let go of outdated trial designs, or will you risk falling behind? Date & Time Oct 23, 2025 1:00 PM - 4:00 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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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!

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