Wednesday, April 15, 2026

NDS, CTD, eCTD - Simplified in One Focused Session

Greetings!


We are hosting a half-day workshop for professionals working in or alongside the drug submission process. If gaps in your regulatory knowledge are slowing you down, this session is worth your time.


The workshop covers the full New Drug Submission process - from drug development and notice types, through to submission formatting, priority review policy, and the Common Technical Document (CTD). A focused portion addresses eCTD submissions specifically, including where and why applications get screened out before they ever reach review.


It is particularly relevant for regulatory affairs specialists, drug development professionals, quality assurance personnel, and anyone involved in the preparation or filing of new drug submissions.


By the end of the session, you will have a clear, working understanding of what a compliant submission looks like, how the approval process is structured, and where most applicants go wrong.


The session will be led by Abdul Hadi Zubair, PMP, Technical Manager - Supplier Quality at Roche and Professor in Quality Assurance and Regulatory Affairs programs. With close to a decade of experience across organizations such as Roche, Bayer, and Elanco, he has been directly involved in the approval and launch of clinical and commercial products, while leading quality systems and ensuring consistent GMP compliance. His experience spans both industry execution and academic instruction, where he regularly trains and mentors professionals in regulatory frameworks, submission strategy, and quality systems.


His background combines strong technical depth with structured project and quality management expertise, supported by certifications in PMP, Lean Six Sigma, and Regulatory Affairs, along with advanced training from the University of Toronto. This allows him to bring not just theory, but real-world insight into how submissions are evaluated, where they fail, and what actually works in practice.

Date & Time

Apr 24, 2026

3:00 PM - 5:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web

Tuesday, April 14, 2026

Early-Bird Discount Expiring in 48 Hours | The GMP Clarity You Actually Need

Greetings!


GMP is one of those things everyone knows exists, but very few teams actually execute properly across manufacturing, documentation, and quality systems. This workshop is designed to bridge that gap. Instead of going through theory, the focus is on how GMP actually applies across real pharmaceutical operations, including manufacturing, packaging, labeling, testing, and control, and what it takes to maintain compliance in a regulated environment. It also addresses what happens when things go wrong, and how non-compliance directly impacts product quality, integrity, and regulatory standing.


The session walks through GMP the way it functions in practice. It covers the core principles, management responsibilities, and how quality is maintained on the floor, along with documentation requirements such as SOPs, validation, and accurate record keeping. Participants will also gain clarity on production controls, sanitation programs, methods and specifications, and how to handle deviations and out-of-specification results. Additional focus is placed on change control, current industry expectations, and how to remain audit-ready at all times, including practical insights into handling inspectors and regulatory audits without last-minute scrambling.


This workshop is relevant for professionals across pharmaceutical, biopharmaceutical, medical device, vitamins, herbals, and allied industries, particularly those working in Regulatory Affairs, Quality Assurance, Clinical Research, Documentation, Product Submission, Project Management, Training, and Product Development. It is equally valuable for managers, supervisors, associates, consultants, and stakeholders involved in bringing products to market or maintaining compliance within regulated environments.


By the end of the session, participants will have a clearer understanding of GMP principles and how they translate into day-to-day operations, stronger capability in developing and maintaining compliant documentation, better control over quality systems and deviation handling, and a more structured approach to preparing for regulatory inspections. All participants will receive a certificate of attendance upon completion. If you are working in a regulated environment, GMP is not something you can afford to be unclear about. Register now.


You can use code SAVE20 to get 20% off as an early bird discount if you register by April 16.

Date & Time

Apr 30, 2026

1:00 PM - 3:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web

Monday, April 13, 2026

LAST CHANCE TO REGISTER: NHP Level 3 is Here - Go Beyond Approval

Greetings!


Level 3 of our Natural Health Products workshop series moves beyond initial approval and into the ongoing regulatory responsibilities that govern products once they are on the market. Building on earlier sessions covering classification, licensing, manufacturing, and labelling, this workshop focuses on maintaining compliance across the full product lifecycle in Canada and beyond.


The session provides a practical overview of Canadian post-market requirements, including importation, exportation, and distribution. Participants will gain clarity on the responsibilities of licence holders, importers, and distributors, along with key exemptions for personal use and clinical trials. The workshop also introduces Master Files and their role in protecting proprietary ingredient information while supporting product licence and clinical trial applications.


A key focus is clinical trial oversight for NHPs. Attendees will learn when authorization is required, how trial phases differ, and what Health Canada expects in terms of applications, ethics approval, and adverse reaction reporting. The session also covers pharmacovigilance requirements, helping participants identify, assess, and report adverse reactions in line with regulatory expectations.


In addition, the workshop provides a comparative overview of international frameworks, including U.S. dietary supplement regulation under DSHEA and FDA oversight, offering insight into global compliance considerations.


This workshop is designed for professionals and students working with Natural Health Products and dietary supplements who need a practical understanding of post-market and global regulatory requirements. It is particularly relevant for those in regulatory affairs, quality assurance, product development, manufacturing, import/export, compliance, and clinical research roles.


The session is led by Andreea Simo, a regulatory affairs and quality professional with experience across global organizations such as PepsiCo and Jamieson Vitamins, as well as consulting firms and start-ups. Her background ensures a practical, industry-aligned understanding of how Natural Health Products are managed beyond approval and throughout their lifecycle.

Date & Time

Apr 17, 2026

11:00 AM - 2:00 PM (EST)


How is the Workshop delivered?

Live. Virtual. Interactive. Instructor-led.

Interested in this workshop?

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

LinkedIn  Web

Friday, April 10, 2026

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

Discover the top events for you in our Weekly Event Guide


Natural Health Products (NHPs) Level 3 Workshop

Apr 17 | 11:00 AM - 2:00 PM (EST)

(Online)

NDS Submissions Explained: Where Applications Break Down

Apr 24 | 3:00 PM - 5:00 PM (EST)

(Online)

GMP in Practice: What Inspectors Expect for 2026

Apr 30 | 1:00 PM - 3:00 PM (EST)

(Online)


Are you ready to expand your learnings?


Broaden your knowledge and delve into new horizons with AAPS!


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