Friday, August 28, 2026

Your Weekly Event Guide: Expand Your Learnings and Discover Exciting Opportunities

Discover the top events for you in our Weekly Event Guide


NDS Submissions Explained: Where Applications Break Down

Sep 10 | 2:00 PM - 4:00 PM (EST) (Online)

Proof, Not Promise: How AI is Actually Changing Pharma

Sep 17 | 2:00 PM - 4:00 PM (EST) (Online)

GMP in Practice:

What Inspections Expect for 2026

Sep 24 | 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!


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Meet the Expert Behind Our AI in Pharma Workshop

Date & Time

Sep 17, 2026

2:00 PM - 4:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Proof, Not Promise: How AI is Actually Changing Pharma

AI Is Changing Pharma. Learn From Someone Who Knows Drug Development From the Inside.


Understanding how AI is reshaping pharma requires more than understanding the technology. It requires an understanding of drug development, clinical research, regulation, and the environments in which these technologies are actually being applied.


That perspective will be at the centre of our upcoming workshop, Proof, Not Promise: How AI Is Actually Changing Pharma, led by Dr. Tigran Uzunyan, Instructor at AAPS.


A medical doctor and research scientist, Dr. Uzunyan brings more than 18 years of experience across academia, the pharmaceutical industry, and clinical research. After earning his medical degree and specializing in clinical pharmacology, he completed his PhD in Pharmacology in 2008.


His experience spans the drug development lifecycle, including the design and conduct of early-phase studies such as bioequivalence, bioavailability, and first-in-human trials, as well as Phase II to IV clinical and observational studies. He has worked with drug development and regulatory requirements across multiple jurisdictions and has also managed medical cannabis development research projects in Canada.


That breadth of experience provides an important lens for examining AI in pharma today: not simply through what the technology promises, but through the realities of evidence, clinical application, risk, regulation, and compliance.


In this workshop, Dr. Uzunyan will explore:

  • The Paradigm Shift: How Big Data and AI are changing pharma’s operating assumptions
  • Discovery, Trials & Safety: Where AI has delivered meaningful results and where evidence remains limited
  • Regulatory Frameworks: How FDA, EMA, and ICH expectations are evolving
  • Context of Use: How to evaluate AI applications through a risk-based regulatory lens
  • The Next 12–18 Months: Developments that could affect regulatory and compliance obligations


Learn from experience that spans medicine, research, clinical trials, and drug development.


Designed for Clinical Research, Regulatory Affairs, and Pharma professionals already familiar with AI basics, this session connects the technology with the real-world scientific and regulatory environment in which it must operate.

Interested in this workshop?

Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

LinkedIn  Web

Thursday, August 27, 2026

What Does It Take to Get a New Drug Approved?

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!


A promising drug doesn’t reach the market on science alone.


Before approval, sponsors must navigate a highly structured regulatory pathway, from determining submission requirements and preparing the right documentation to pre-submission meetings, screening, CTD organization, and regulatory review.

If you work in or are entering Regulatory Affairs, understanding how these pieces fit together is essential.


In this introductory workshop, you’ll get a practical overview of the New Drug Submission (NDS) process and learn how to:

  • Understand the key stages of drug development and approval
  • Navigate the components and requirements of an NDS
  • Recognize different notice types and priority review considerations
  • Understand the role of pre-submission meetings
  • Explore submission formatting, filing, and screening
  • Understand the structure and modules of the CTD
  • Learn how eCTD supports modern regulatory submissions


Rather than looking at each requirement in isolation, you’ll see how the regulatory submission process connects from drug development through filing and review, giving you a stronger foundation for working with pharmaceutical submissions.


Whether you're new to Regulatory Affairs or looking to strengthen your understanding of the NDS process, this workshop will help you build the regulatory knowledge behind bringing new drugs toward approval.



*All participants will receive a Certificate of Attendance upon completion.

Interested in this workshop?

Register today by calling our team at 416-628-7575 or email us at events@aapspharma.com

LinkedIn  Web