|8.30|||||Leading Minds FUELS the Cold Chain – Industry Colleague Team Building Session|
|9.00|||||Regulatory Inspector Presentation: The Importance of Data Integrity in Meeting Good Distribution Practice Requirements in Today’s Pharmaceutical Supply Chain|
|Terence Madigan, GDP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA)|
|9.45|||||Interpretation of GDP for Temperature Sensitive Shipments in the Pharma Supply Chain|
|Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer|
|11.00|||||Setting up a Global Data Monitoring System: Preparing for Shipment Analytics|
|Wim Vangoidsenhoven, Independent, Transportation and Cold Chain Practitioner|
|11.45|||||Problem-Solving Small Group Discussions|
|A) Temperature Deviations Management – Closing the Alarm to CAPA Time Gap|
|B) Weak Points in the Data Supply Chain – Where and How Would More Logistics Data and Visibility be Helpful?|
|Discussion Leader: Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer|
|C) Building SOPs that Ensure Clinical Sites, Staff and Equipment are Monitored and Quality Controlled|
|D) Understanding New Data Integrity Regulations from Around the Globe|
|E) Deciding the Best Approach for Low Temperature Shipments & Sharing Cryo Experiences|
|Volker Kirchner, Director Temperature Control, World Courier|
|13.45|||||Five Minute Recap and Summary on Problem Solving Group Discussions|
|14.15|||||Using Temperature Data Analysis to Statistically Evaluate your Cold Chain Performance and Reduce Logistics Costs|
|- New Data Integrity regulatory guidelines – how using a central document management system for temperature data fits in this new world of Data Integrity requirements|
|- Building the data sets required for meaningful statistics|
|- Defining what type of statistics will help you make cost cutting decisions|
|Cyril Winkler, Head of Product Management, ELPRO|
|15.00|||||Inspired by Clinical Supply in Africa - A Unique Experience in Sierra Leone|
|- Considering infrastructure and other set up requirements|
|- Training of local staff on quality control process and temperature monitoring requirements|
|- Logistics challenges in remote clinical trials|
|- Advice for other practitioners operating clinical trials in remote areas – how to ensure quality control of clinical trial medicines|
|Gino Vleugels, Senior Manager EMEA Temperature Control, Johnson & Johnson|
|16.15|||||Community Forum Discussion: Transport Qualification|
|- First – know your limitations, product requirements and scope of project|
|- Considering differing approaches to set up qualification of lanes|
|- CRT vs Cold Chain product qualifications|
|- Access to, use of stability data|
|- Network mapping – analyzing the data, defining profiles|
|Discussion Leader: Martin Peter, Vice President, ELPRO|
|17.00|||||Community Forum Discussion: Stability Budget Approaches|
|- What’s stopping you from using a stability budget?|
|- Cumulative TOR vs Stability Budget vs your company’s definitions|
|- Manuel, Distribution, vs Push Forward – approaches to setting up and managing a budget|
|- Shipping outside of label claim|
|- Regulatory input and experiences|
|17.30|||||FUEL Session – Industry Team Building|
|18.05|||||Networking Drinks Reception|
DAY TWO Wednesday April 13th - User Group Meetings
9.00 – 16.00 (concurrently running in separate rooms)
ELPRO User Group Meeting
The ELPRO User Group day will consist of various formats including a series of small breakout discussions, that will rotate so participants have a chance to join more than one topic. Also groups will be broken into experience level for some discussion topics, to create more focused, detailed discussions. Finally, there will time dedicated to clinical shipments and supply chain; whilst concurrent discussion on commercial shipment challenges. If you have suggestion of topics or format for the UG day, please email cbecker-james[at]elpro.us.
- Incorporating stability data into your profiles and monitoring approach. «Data in Action» – Looking at possible allowable excursions
- Stability Budget 201 - next steps to establishing a usable approach to track excursions throughout the lifecycle of your products
- PQ / OQ Requirements: Does your approach meet regulatory and industry standards
- Transport Qualification – Benchmarking with other company approaches
- Thermal mapping strategy and analysis of trucks, and warehouses
- Setting up a centralized database for temperature data. Correct data input = meaningful data out.
- Challenges in working with third parties in implementing a new data monitoring system
- Multi component shipments – releasing partial shipments
- Challenges in shipping cryo – does your API or clinical materials have special requirements?
- End User Group Live Shipment Study – Handling the release, upload to database, evaluation of stability data and correct handling alarms in elproVIEWER
- End User Group for Clinical Supply and Site Monitoring – How to get most use of out of CONFIG Utility – correct report titles, file names, where to put certain information
- End User Group – using liberoMANAGER to perform searches, segment data, start defining trends
- Advanced User Group – Using liberoMANAGER to Track TOR or Stability Budget
Envirotainer User Group Meeting
Envirotainer will present the first part of the day on reliability in the cold chain and present an update to our Telemetry solution from last year. Throughout the day, groups will have a chance to break-out in smaller teams and have closer discussions on these topics:
- How do industry leaders build the highest quality into a reliable cold chain?
- What does the most sustainable cold chain look like?
- What are the common pitfalls in attaining a reliable cold chain and what are the solutions in prevention?
- What is the promise of telemetry?
- Relevant and actionable data to secure decisions and minimize risks across the supply chain
- Case studies: real life pilots on RAP e2 containers using Envirotainer’s integrated visibility solution
ELPRO, founded in 1986, is a leading Swiss manufacturer of innovative monitoring solutions and data loggers for documenting environmental conditions in cold chain transportation, production facilities and warehouses. ELPRO partners with clients to develop solutions that integrate ELPROs high-quality measurement components into their business processes. Clients include biotechs, diagnostic manufacturers, and top 20 pharmaceutical companies. As the inventor of the LIBERO PDF Logger, ELPRO supports pharmaceutical and healthcare companies around the world in simplifying their cold chain while having less manual work thus reaching quicker release times.
The first Leading Minds Seminar was May 2015 in New Jersey with 64 pharmaceutical manufacturers attending, plus MHRA and US Pharmacopeia speaking. Learn from key highlights – click here for the detailed post-event report.
Comments from 2015 attendees:
«I was particularly interested in the thoughts/opinions/positions from the regulatory agency speakers. I also wanted to hear from other companies to see what troubles they were having, where their pain points are, etc.»
«I took away ideas on central data base for stability data supporting distribution and immediate knowledge of the temps seen in distribution. All in one place to answer those excursion question immediately.»
«I gained more information in this free session than I have at any of the paid sessions. I was there to listen to others and come away with some new ideas and/or perspectives.»