In today’s global life sciences landscape, packaging and labeling sit at the intersection of clinical operations and supply chain orchestration with the influence of digitization. Yet, misalignment between teams continues to cause costly delays, material waste, inspection findings, and compromised trial timelines.

The workshop will guide participants through the inputs they need to build an end-to- end strategy for packaging and labeling across international markets—ensuring clinical intent is flawlessly executed throughout the supply chain. Case studies and exercises will be shared to promote interactive learning and group discussion on the following topics:

• Supply planning strategies with a focus on study startup activities, including forecasting, packaging, labeling, IRT, storage, and distribution.
• Strategies for waste reduction and increase responsiveness to changing study needs.
• Examine digital tools, process harmonization, and the role of AI in modernizing clinical packaging operations.
• Understand global packaging and labeling configurations and their downstream implications.
• Digital platforms to improve speed, precision, and operational consistency.

Click here to learn more about the pre-conference workshop.

Instructors:
Dana Berger, Clinical Supply Chain Manager, Almac Group
Shannon Detweiler, Supply Chain Manger, Global Project Manager, Almac Group

Generative AI tools such as ChatGPT, Microsoft Copilot, and Google Gemini are already reshaping how supply chain teams analyze data, solve problems, and communicate. Yet many professionals struggle to move beyond experimentation and apply these tools effectively, safely, and responsibly in real-world, regulated environments.

This interactive workshop is designed specifically for supply chain professionals who want to use AI today—without needing to be programmers or data scientists. Participants will learn a simple, repeatable framework for “talking to AI” and apply it to common supply chain scenarios, including inventory management, supplier and CMO coordination, logistics challenges, quality events, and executive communication.

Through guided exercises and real-world examples, attendees will transform everyday supply chain tasks into reusable AI-powered workflows they can immediately apply in their organizations.

By the end of the workshop, participants will be able to:

• Explain what generative AI is—and is not—in clear, practical terms, and where it realistically fits in today’s supply chain operations.
• Use a structured prompting framework (role → context → task → constraints) to consistently obtain higher-quality outputs from AI tools.
• Apply generative AI to common supply chain tasks, including:
  • Turning KPI dashboards and Excel data into insights and executive-ready narratives
  • Drafting supplier and CMO communications and action plans
  • Summarizing SOPs, deviation reports, and meeting notes
• Design 3–5 “quick-win” AI use cases tailored to their own organization, spanning personal productivity, team workflows, and cross-functional collaboration.
• Identify and manage AI-related risks relevant to supply chains, including hallucinations, outdated information, data confidentiality, regulatory and GxP considerations, and over-reliance on non-validated outputs.
• Critically evaluate AI outputs using simple validation techniques such as cross-checks against systems of record, spot reviews, and defined approval steps prior to operational use.

What Participants Will Take Away:

• A starter library of supply-chain-specific AI prompts
• Clear do’s and don’ts for using AI safely and responsibly in regulated environments
• A prioritized list of quick-win AI use cases to pilot within the next 30–60 days

Skills You Will Strengthen:

• Personal productivity and professional communication
• Analytics and KPI interpretation
• Supplier and CMO management
• Operations, planning, and exception management
• Quality, compliance, and documentation (non-GxP drafting)
• Data and document handling
• Executive-ready storytelling

Instructors:
Dr. Siamak Zadeh , Chair AI Initiative and Associate Professor and Data Scientist, Golden Gate University
Rich Kilmer , CEO, CargoSense
Amar Saurabh , Product Leader, PayPal

A 4-Hour Deep-Dive to Reduce Risk, Prevent Delays & Build a World-Class Compliance Program.

Global supply chains in Life Sciences are more regulated, more complex, and more unforgiving than ever. A single misclassified reagent, an incomplete FDA entry, or an unnoticed export restriction can cause customs detentions, penalties, shipment delays, patient impact, and millions in added cost.

To help industry professionals navigate these challenges, BSMA is hosting a focused, high-impact, four-hour International Trade (Import & Export) Compliance Workshop, designed specifically for Biopharma, MedTech, Diagnostics, and Healthcare organizations.

Workshop Agenda (At a Glance):

• In the first half of this 4 hour workshop, we will cover the importance of Global Trade Compliance, crucial Import concepts (such as customs valuation, HS classification, Country of origin etc.), export concepts (such as licensing, ECCN numbers, sanctions, restricted party screening), common errors and enforcement trends.  We will also discuss industry best practices to comply with import & export regulations.
• In the second half, we will discuss how to develop a Global Trade Compliance program with guidance from industry representatives.

What Participants Will Experience:

• In-depth discussion on import compliance topics (such as customs valuation, HS classification, Country of origin etc.)
• In-depth discussion on export compliance topics (such as licensing, ECCN numbers, sanctions, restricted party screening)
• Panel Discussion with industry experts
• Networking and Community Engagement: An opportunity to build connections across vendors, sponsors, and practitioners in a neutral setting

Instructors:
Deep SenGupta, CEO/ Founder, DSG Global LLC
Dale Bushell , Director of Pharmaceuticals, VAT IT
Ladislav Vondrasek , SVP Global Clinical Supply Chain Operations, Sanaclis
Maja Kuhnt , Director Competence Center Group Customs & Trade, Arvato SE

The Qualified Person (QP) plays a legally mandated and strategically critical role in the EU clinical trial supply chain, ensuring that Investigational Medicinal Products (IMPs) meet the highest standards of quality, safety, and regulatory compliance before they are administered to trial participants.

This specialized workshop will explore the EU regulatory framework governing the QP function and examine how QP oversight—spanning GMP audits, batch certification, and release activities—directly impacts the efficiency, compliance, and success of clinical trials conducted in the European Union.

Participants will gain insight into why early and continuous engagement with the QP is essential during trial planning and supply chain design. Proactive collaboration helps maintain supply continuity, reduces regulatory and logistical risks, and minimizes potential delays to clinical trial timelines. The workshop will also address best practices such as establishing clear quality agreements and ensuring timely readiness of documentation and facilities for QP review.

What Will You Learn?

• The duties, responsibilities, and legal requirements of a Qualified Person under the EU Regulatory Framework
• Pharmaceutical qualifications and professional experience required for QP registration with a Member State’s competent authority
• The role of the QP in the release of Clinical Trial Material (CTM) within the EU
• Requirements for the performance and oversight of GMP audits and their impact on trial readiness

Instructors:
Sascha Sonnenberg , Vice President, Global Business Development & Country Head Germany, SanaClis
Marian Kulich , Vice President, Clinical Supply Chain Operations, SanaClis

Sponsored By CargoSense
Supported by BSMA
Leadership isn’t luck—it’s showing up. 🍀 Join WILS for a hands-on workshop to expand your influence, advocate for others, and leave your mark in life sciences and supply chain.

Make Your Mark — WILS Pre-Conference Workshop
This St. Patrick’s Day, go beyond showing up—make an impact! Join Women in Life Sciences – Supply Chain Management (WILS-SCM) for a hands-on workshop where rising and seasoned leaders learn to expand influence, advocate for others, and lead with purpose. Through guided exercises and fireside conversations, you’ll walk away with practical strategies, new connections, and one action to make your mark. Leadership isn’t luck—it’s showing up, speaking up, and shaping the future.

• 3:00 PM: Welcome Address
  “Leadership Isn’t Luck” Opening remarks by the WILS-SCM Leadership Team
  The session opens with a warm welcome from WILS leadership! It will set the tone and remind participants that everyone already has a seat at the table. Tied into the St. Patrick’s Day theme, the next two hours of discussions activites and leadership insight emphasize that while luck may get you noticed, intention is what makes you memorable. Following the introduction, we will transition into an interactive icebreaker, where participants are encouraged to reflect in pairs or small groups on a moment when they realized their perspective mattered, even if they chose not to speak up at the time.Kristin Ekwall, CargoSense
  Co-Chair WILS-SCM
  Mary Yurkovic, BSMA
  Co-Chair WILS-SCM

• 3:10 PM – 3:35 PM: Skill Builder: Influence Without Authority
  Leadership influence isn’t about having the perfect title or waiting for the right moment; it’s about intentional participation in the moments you’re already in. Speaking up becomes leadership when you anchor your perspective to outcomes rather than emotion. Advocating for others in rooms they’re not in builds trust and expands your credibility. Everyday interactions — how you frame a challenge, ask a question, or redirect credit — are quiet leadership opportunities. And moving from “firefighter” to “shaper” means looking beyond solving the immediate issue to addressing the pattern behind it. Most barriers to influence are internal narratives, and those can be rewritten. The shift is simple: be 10% more intentional with the seat you already have. This facilitated discussion will include Topics + Tips such as

   

  • Speaking up without being labeled “difficult”
  • Advocating for others in rooms they’re not in
  • Turning everyday moments into leadership moments
  • Moving from “firefighter” to “shaper”

  What holds you back most from using your seat fully?

  Facilitated By:
  Dyma Khudari
  WILS-SCM Vice Chair
  Audra Gavelis, AeroSafe
  WILS-SCM, Mentorship & Career Development Co-Lead

• 3:35 PM – 4:05 PM: Guided Exercise: Mapping Your Mark
  In this guided exercise, participants will begin with individual reflection, identifying where they already influence outcomes — across projects, people, and decisions — where they would like to expand their impact, and who benefits when they use their seat intentionally. We will then move into small group discussion to explore insights from the exercise, including what surprised them, where they may be underestimating their influence, and how one small, deliberate action could create meaningful ripple effects.
  
  Facilitated By:
  Mechelle Moore, CargoSense
  WILS-SCM Events & Programming Lead
  Leslie Rodriguez, CargoSense
  WILS-SCM, Communications & Marketing Lead

• 4:05 PM – 4:30 PM: Fireside Chat: From Seat to Signature
  In this fireside conversation, 4 empowering leaders will share how they transitioned from dependable contributors to recognized influencers. Their stories will prove how leveraging influence beyond formal titles or tenure and advocating for others can also help advance one’s own career. Reflecting on moments of realizing influence without authority, ways they intentionally use their position today, and insights they wish they had known earlier. This is a not-to-miss authentic conversation with 4 influential and trusted leaders.
  Panelists:
  Rebecca Beam, Zavikon
  Tammy Bishop, Acnos Pharma
  Dr. Aischarya Brahma, SmartCAE

   

  Moderated by:
  Laura Shuga, Bayer
  WILS-SCM Career Development Co-Lead

• 4:30 PM – 4:50 PM: Make It Real: One Move, One Commitment
  Personal Action Planning!
  In this Personal Action Planning session, attendees set concrete goals by identifying one person they will advocate for, one conversation they will initiate, and one behavior they will approach differently. They then pair up to share their commitments, completing the statement, “By the end of this conference, I will…” to reinforce accountability and reflection.
  Facilitated By:
  Jenifer Arellano, Direct Relief
  WILS-SCM Membership & Community Engagement Lead
  Nevada Blair, WILS-SCM Mentorship & Career Development Co-Lead

• 4:50 PM – 5:00 PM: Closing & Call to Connection
  The WILS-SCM community and ongoing engagement go beyond this workshop and the BSMA Conference. Join us in 2026 in all of our activities!
  Leadership isn’t about luck.
  It’s about choosing again and again to make your mark.
  Kristin Ekwall, CargoSense
  Co-Chair WILS-SCM
  Mary Yurkovic, BSMA
  Co-Chair WILS-SCM

• 5:30 – 6:30 PM: Cocktail Reception

(Led by the RPS Group – RTSM Professional Society)

Randomization and Trial Supply Management (RTSM) systems (also referred to as Interactive Response Technology (IRT) systems) sit at the center of modern clinical trial execution, connecting clinical operations, supply chain, data integrity, and patient access. As trials grow more complex, decentralized, and global, misalignment between RTSM capabilities and operational needs continues to drive inefficiencies, rework, and risk.

This full-day, in-person RTSM Workshop, supported by the RTSM Professional Society (RPS) and held the day before the BSMA 2026 Global Conference, brings together RTSM vendors, clinical operations leaders, supply chain professionals, and RPS leaders and members to focus on how RTSM systems are evolving and how they should be used in practice.

Designed to go beyond marketing demos and competitive positioning, this workshop emphasizes real-world capabilities, operational standards, and cross-functional dialogue.

What Participants Will Experience:

• In-Person RTSM Vendor Showcase
• Audience Expansion Beyond Traditional Supply Chain
• RPS-Led Standards and Industry Discussion
• Networking and Community Engagement

Workshop Agenda (At a Glance)

• Morning Session: RTSM vendor showcases
• Lunch: Provided
• Afternoon Session:
  • RPS presentation
  • Facilitated discussion on RTSM standards and operational alignment

Instructors:
Derek Thornton, Associate Director, Clinical Systems (IRT), Amgen
Catherine Hall, Head of GxP Quality Assurance, Egnyte