Friday, February 6, 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 1 Workshop

Feb 20 | 11:00 AM - 2:00 PM (EST)

(Online)

Practical Guide for Sponsors Planning an Expanded Access Program (EAP)

Feb 25 | 1:00 PM - 3:00 PM (EST)

(Online)

Developing an Effective CAPA Strategy

Feb 26 | 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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Strengthening CAPA Through Lean Thinking and Root Cause Analysis

Greetings!


Quality systems fail when corrective action stops at fixing symptoms instead of preventing recurrence. Many CAPA processes focus on closing deviations, but without clear problem definition and true root cause identification, the same issues continue to reappear. In regulated environments, this not only weakens compliance but also creates operational inefficiency, inspection risk, and unnecessary rework.


This workshop introduces a Lean-based approach to CAPA that moves beyond surface-level explanations such as “human error” and focuses on process design, workflow clarity, and systemic improvement. Participants will learn how Lean principles can be applied to identify non-value-added activities, define problems accurately, map real operational processes, and develop corrective actions that address root causes rather than symptoms. The emphasis is on building CAPA systems that strengthen both regulatory compliance and day-to-day operational performance.


The session is designed for quality assurance professionals, internal auditors, regulatory compliance teams, and professionals working in pharmaceutical, biotechnology, and medical device environments who are responsible for CAPA systems, inspections, and quality oversight. It is equally valuable for those seeking to strengthen their understanding of Lean problem-solving, process improvement, and sustainable quality system design.


The workshop is led by Terry Pilkey, a Chartered Chemist with over 30 years of experience in the pharmaceutical industry, including more than 13 years at Health Canada within the Health Product Branch Inspectorate and current leadership as Director of QA/QC at Experchem Laboratories Inc. Her experience spans GMP inspections, compliance oversight, auditing, and laboratory quality systems, bringing both regulatory and operational perspectives into applied learning.


Take advantage of an exclusive 20% registration discount. Use code SAVE20 at checkout and secure your spot today.

Date & Time

Feb 26, 2026

2:00 PM - 4:00 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

Thursday, February 5, 2026

How Natural Health Products Are Regulated in Canada (From Licensing to Compliance)

Greetings!


Understanding how Natural Health Products are regulated in Canada is essential for anyone involved in developing, licensing, marketing, or maintaining compliance for these products. This workshop provides a clear and practical overview of how NHPs are regulated under the Food and Drugs Act and the Natural Health Products Regulations, including the roles of Health Canada, the NNHPD, and enforcement bodies. Participants will learn what qualifies as an NHP, how NHPs differ from drugs and supplemented foods, and why correct product classification is critical to avoiding compliance risk.


The session walks through the full regulatory lifecycle of an NHP, from product classification and licensing to post market obligations. Attendees will gain practical insight into application classes, monographs, claims and evidence requirements, traditional and homeopathic products, and the regulatory tools used to submit and manage applications. The workshop also covers operational requirements such as labeling, adverse reaction reporting, recalls, and ongoing compliance responsibilities, helping participants understand what regulators expect both before and after licensing.


This workshop is designed for professionals and students who work with, or plan to work with, Natural Health Products in Canada and need a solid understanding of regulatory expectations. It is particularly relevant for those in regulatory affairs, quality assurance, product development, manufacturing, labeling, compliance, and market authorization roles, as well as importers, distributors, consultants, and entrepreneurs bringing NHPs to market. Students in life sciences, nutrition, health sciences, pharmaceutical sciences, or regulatory affairs will also benefit from the foundational, applied perspective offered.


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 spans regulatory affairs, product development, and quality assurance for natural health products and foods, offering a balanced view of how products are developed, assessed, and brought to market in real world settings.

Date & Time

Feb 20, 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

Tuesday, February 3, 2026

Expanded Access Programs From Regulatory Concept to Execution-Ready Strategy

Greetings!


Expanded Access Programs are becoming an increasingly important part of drug development when patients cannot wait for standard clinical trial timelines or commercial availability. While these programs can provide critical access to investigational therapies, many sponsors struggle to design EAPs that are regulator ready, operationally feasible for clinical sites, aligned with pharmacovigilance expectations, and consistent with long-term development strategy.



This workshop provides a practical, sponsor focused guide to building an Expanded Access Program from end to end. Participants will learn how to define program intent, select the appropriate program model, develop an execution-ready protocol structure, establish a realistic minimal dataset, and plan cross-country implementation using a clear and reusable framework that balances compliance with feasibility.


The session covers early access pathways such as EAPs, post-trial access, and open label extensions, along with the trial-first principle, access versus study-style models, protocol design essentials, safety oversight, data strategy, and operational planning. Attendees will gain practical tools to avoid common regulatory and execution pitfalls while creating programs that support both patient access and development goals.


This workshop is designed for professionals involved in clinical development and regulatory execution, including medical writers, regulatory affairs teams, clinical operations leads, pharmacovigilance professionals, medical affairs staff, CRO project teams, quality and compliance professionals, and investigators supporting early access requests and reporting.


The session is led by Dr. Tigran Uzunyan, a physician and clinical pharmacologist with over 18 years of experience across academia, pharmaceutical development, regulatory strategy, and clinical research. His background spans early phase and late phase clinical studies, multi-jurisdictional regulatory work, and real-world research programs, bringing a practical and lifecycle-focused perspective to Expanded Access planning and execution.


We look forward to welcoming you to this in-depth and applied session on building regulator-ready Expanded Access Programs.

Date & Time

Feb 25, 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, February 2, 2026

What’s Coming Up in February

Discover the best events in our February, 2026 Event Guide

Because every month is a new chance to learn and grow.

SoP Masterclass: Writing Effective Standard Operating Procedures


Feb 5th, 2026 (Online)


1:30 PM - 4:30 PM (EST)



Build clear, compliant SOPs that improve consistency, meet GMP expectations, and stand up to audits through practical writing, change control, and real world exercises that strengthen daily operations and regulatory readiness.

Natural Health Products (NHPs)- Level 1 Workshop



Feb 20th, 2026 (Online)


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



Learn how Natural Health Products are regulated in Canada, from product classification and licensing pathways to labeling, claims, GMP, post market compliance, and Health Canada enforcement across the full lifecycle.



Practical Guide For Sponsors Planning An Expanded Access Program (EAP)



Feb 25th, 2026 (Online)


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




Design regulator ready Expanded Access Programs with clear sponsor intent, execution focused protocols, minimal datasets, and cross country planning that aligns clinical, regulatory, and safety teams.


Developing an Effective CAPA Strategy



Feb 26th 2026 (Online)


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



Strengthen CAPA systems using Lean principles to identify real root causes, streamline processes, reduce deviations, and implement corrective actions that drive lasting compliance and operational efficiency.


Interested to know more about AAPS Pharma?

To learn more, call our team at 416-628-7575 or visit us at www.aapspharma.com

LinkedIn  Web