Friday, April 17, 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

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)

Bringing Medical Devices to Market: Understanding the Regulatory Pathway

May 14 | 12:00 PM - 2:00 PM (EST)

(Online)


Are you ready to expand your learnings?


Broaden your knowledge and delve into new horizons with AAPS!


LinkedIn  YouTube  Facebook  Instagram  Web

Thursday, April 16, 2026

Medical Devices in Canada: Regulatory Pathway

Greetings!


A medical device rarely gets held back because the science isn’t strong. More often, it’s a decision. A classification that shifts the entire requirement. A document that doesn’t land the way it should. A submission that looks complete, but doesn’t move.


From the outside, the pathway in Canada appears structured. Classes are defined, regulations are documented, and the steps seem clear. But once you’re inside the process, it becomes a sequence of calls that determine whether something progresses smoothly or slows down without warning.


This 2-hour workshop is built around that reality. It walks through how medical devices are regulated under Health Canada, how risk-based classification actually shapes the pathway, and how market authorization is approached when these decisions are made in practice. The focus is on understanding not just what is required, but how it is applied, where submissions tend to face resistance, and how regulatory strategy supports both approval and what follows after.


The session is led by Cecile Cualing, a pharmacist and regulatory affairs professional who has worked across both pharmaceutical and medical device environments. Her experience spans Health Canada, the U.S. FDA, and notified bodies, but what distinguishes her approach is where she started. Her early work in pharmaceutical manufacturing, in formulation and quality control, shaped how she understands regulation today. It is not separate from development or production. It sits within it. That perspective carries through her regulatory work, where she has supported market authorization and lifecycle management in real settings, and it informs how she explains decisions that are often reduced to checklists.


All participants will receive a certificate of attendance upon completion. Register by April 23 to receive 20% off using code SAVE20.

Date & Time

May 14, 2026

12:00 PM - 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

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