EU Seminar

Practical Approaches to Temperature Controlled Pharmaceutical Logistics and Storage

April 12th & 13th 2016 – Hotel BLOOM! Brussels, Belgium | Cancelled due to the sorrowful situation in Brussels after the terror acts

Unique Format
The seminar is complimentary (no fee) attendance to pharmaceutical manufacturers.

Think industry retreat. No, not paintball or karaoke. Instead bringing together the best minds from pharmaceutical manufacturers and supply chain partners to resolve very real, specific challenges. The full intention of LM Seminars is to create an open dialogue, no pressure, relaxed environment that FUELS the cold chain. The majority of the program is discussion-based. Download the 2016 program here.

F
usion of
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E
xperiences in
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No press, no sponsorships at Leading Minds Seminars only further FUELS a positive, open exchange environment.

Leading Minds Seminars are complimentary attendance for pharmaceutical manufacturers.

Why

The challenges for temperature controlled pharmaceuticals are complex and require well thought through, structured and collaborative approaches. There are no quick fixes, unless you have an unlimited budget.

The Leading Minds Seminar is designed to have peer-to-peer interaction to educate participants how to comply with global GDPs and put each of the components together to create a cost-effective, compliant temperature control chain.

ELPRO and Envirotainer bring together more than three decades of cold chain experience with small, medium size and large multi-national pharmaceutical companies. We are serious about education and bringing leading minds together to collectively further best practices, as well as work toward your own specific company goals.

In May 2015, the first seminar in New Jersey, USA brought 65 professionals together, most pharmaceutical manufacturers. The feedback was extremely positive.

Seminar Presentations and Discussion Topics:

DAY ONE Tuesday April 12th

8.00   |   Welcome Coffee
         
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
         
10.30   |   Networking Break
         
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
         
12.45   |   Lunch
         
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
         
15.45   |   Networking Break
         
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
         
18.00   |   Closing Remarks
         
18.05   |   Networking Drinks Reception
         
19.00   |   Dinner
         


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.
Topic include:

  • 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

→ Download 2016 Program

Program and Networking
Day One – presentations, small group discussions, problem solving breaks outs. The day concentrates on current affairs, regulations and practical case studies that seek to solve business critical issues.

Evening Networking – Dinner and drinks

Day Two - User Group meeting(s) in two separate rooms that discuss ELPRO/Envirotainer specific technology and trends in that technology area including implementation challenges and sharing of customer experiences

So many events, so little time. Why this one?
Projected forecasts predict higher volume of products requiring temperature control; however at the same time the industry continues to consolidate and move toward more strategic partnerships with supply chain partners. ELPRO and Envirotainer have been involved in developing cold chain systems for decades. Applying our extensive experience we want to facilitate the right discussions, between the right supply chain partners to ensure successful business outcomes now, and for the long term.

Tradeshows serve a purpose, but sometimes you need more than «information overload». Rather you need a focused group of people, concentrating on developing a detailed, step by step process approach to find the complete solution that you need.

Additional Information

Format
The seminar is complimentary (no fee) attendance to pharmaceutical manufacturers.

Bringing together the best minds from pharmaceutical manufacturers and supply chain partners; the first day program will consist of presentations and group discussions concentrating on current affairs, regulations and practical case studies that seek to solve business critical issues. The second day will be User Group meeting(s) in two separate rooms that discuss ELPRO/Envirotainer specific technology and trends in that technology area including implementation challenges and sharing of customer experience to solve day to day issues participants are facing.

Participants will enjoy networking with other temperature control logistics and QA professionals during informal discussions, luncheon and networking evening in Brussels, Belgium.

Location and Hotel
Hotel BLOOM! Brussels,  Rue Royale 2015 Koningsstraat 250, 1210 Brussels, Belgium

The Leading Minds Seminar has a negotiated rate of € 155.00 / night for bedrooms.

Seminar hosted by:

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.

Envirotainer is the world leader in secure cold chain logistics solutions within the life science industries. The company manufactures and leases active temperature-controlled container solutions for air transportation, including validation, support and service. Envirotainer operates through an open, global network of airline companies and logistics partners. The company is represented in over 50 countries around the world with headquarters in Upplands Väsby just outside of Stockholm, Sweden. Envirotainer is a registered trademark of the company Envirotainer AB.

2015 Impressions

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.»