Day 1 : Sunday, April 21
Expanded Access
Inspection Readiness
IRT Deep Dive
Mastering Clinical Supply Planning
Planning the clinical supply chain can be an extremely difficult task. Between the quantity of information to consider, the uncertainty of future trials, the  missing information, clinical supply managers can easily feel under pressure to deliver a safe, yet efficient, supply plan. This bootcamp aims at teaching  methods to streamline the planning process, from data collection, to planning  methods, and share good practices to easily improve the quality of your  planning. This one-day session will bring attendees through different steps  of forecasting and planning in clinical supply chain. Together, we will  address the basics and quickly move into sharing concrete, actionable good practices
- An introduction to planning & forecasting in clinical supply
- Collecting assumptions and working with limited data
- Good practices & pitfalls in planning
-  Impact of external events and decisions on your planning – How to turn this to your advantage?
- Interactive exercises to apply learnings
Understanding the Essentials of the Clinical Supply Chain
Day 2 : Monday, April 22
L1 - Cell and Gene Therapy Supply
L2 - Data & Analytics to Drive the Clinical Supply Chain
L3 - Using AI to Predict Enrollment
WS01 - Precision Dispensing - Packaging Labeling And Dispensing From Central Pharmacy
WS03 - How to Use ChatGPT to Write UAT Scripts for IRT and Perform Clinical Planning
WS05 - Updates On New Regulations, Understanding Their Impact
WS06 - Navigating Ancillary Management Challenges
This interactive discussion will cover topics such as:
- Identify important considerations for ensuring compatibility of IMP with  common infusion materials and how they impact delivery of drug to the patient
- Identify key stakeholders (e.g. CMC, Clinical, CROs, CMOs) that are  involved in the process and how they may be leveraged to support the process.
- Discuss how to develop a plan to ensure availability and continuity of compatible ancillaries across all regions the trials will be conducted in
- Poll group and review pros and cons of different organizational  approaches to management and delivery of ancillary supplies
WS15 - VAT Recovery
WS20 - SMART Packaging for Adherence Measurement: Understanding the Impact on Supply Planning
WS21 - Inspection Readiness Across the Pipeline
WS27 - Remote Working and Returning to the Office
WS04 - Resources to Assist Patients in Identifying and Navigating Clinical Trials
WS08 - Understanding the Requirements & Challenges for Importer of Record (IoR)
WS10 - Lessons Learned After 30 Years In Clinical Supplies
WS11 - Understanding EU Labeling Regulations
WS12 - Regulatory Label Requirements for Comparators
WS17 - Clinical Supply Chain Open Forum
WS23 - Latest ERP SYSTEMS / Solutions and What Challenges Are Faced
WS24 - Comparator Sourcing Challenges & Supply Chains
WS26 - Essential Leadership Skills
WS28 - Building Accountability Within Your Team
WS29 - DTP
L4 - Getting the Most Out of Your IRT User Experience
WS02 - Strategies to Evaluate & Mitigate Clinical Supply Risk
WS07 - What to Consider When Getting into Cell & Gene Therapy
WS09 - Overcoming the Black Box Effect in Forecasting and RTSM
WS13 - Japan: Direct to Patient and The Decentralized Landscape
WS14 - Understanding the Importance and Required Processes of Reconciliation & Destruction
WS16 - Clinical Supplies Stakeholder Management
WS18 - How to Accomplish Drug Pooling in Europe
WS19 - Using Data to Find Wasteful Processes and Cost Savings
WS22 - End-to-End Clinical Supply Management
WS25 - Selection of Vendor Companies & Partnering with Internal Stakeholders During the Process
Day 3 : Tuesday, April 23
L2 - Data & Analytics to Drive the Clinical Supply Chain
L1 - Cell and Gene Therapy Supply
L3 - Using AI to Predict Enrollment
WS01 - Precision Dispensing - Packaging Labeling And Dispensing From Central Pharmacy
WS03 - How to Use ChatGPT to Write UAT Scripts for IRT and Perform Clinical Planning
WS05 - Updates On New Regulations, Understanding Their Impact
WS06 - Navigating Ancillary Management Challenges
- Identify important considerations for ensuring compatibility of IMP with  common infusion materials and how they impact delivery of drug to the patient
- Identify key stakeholders (e.g. CMC, Clinical, CROs, CMOs) that are  involved in the process and how they may be leveraged to support the process.
- Discuss how to develop a plan to ensure availability and continuity of compatible ancillaries across all regions the trials will be conducted in
- Poll group and review pros and cons of different organizational  approaches to management and delivery of ancillary supplies