Practical Approaches to Temperature Controlled Pharmaceutical Logistics and Storage. April 12 th & 13 th 2016 Hotel BLOOM!

Transcription

1 1 Practical Approaches to Temperature Controlled Pharmaceutical Logistics and Storage April 12 th & 13 th 2016 Hotel BLOOM! Brussels Belgium Seminar hosted by ELPRO and Envirotainer

2 2 Leading minds seminar brussels, BE april 2016 Unique Format Think industry retreat. No, not paintball or karaoke. Instead bringing together the best minds from pharma ceu tical 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. Fusion of Useful Experiences in Logistics and Storage No press, no sponsorships at Leading Minds Seminars only further FUELS a positive, open exchange environment. The seminar is complimentary (no fee) attendance to 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-topeer 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. Who - Pharmaceutical manufacturers - Generic, non-branded manufacturers - Diagnostic and medical device manufacturers - Biotech - 3PLs / specialty couriers - Freight forwarders - Transportation companies including airlines and trucking - CROs 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. Trade shows 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. Program & 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 Registration The seminar is complimentary (no fee) attendance to pharmaceutical manufacturers. Each registration includes the Leading Minds Seminar, User Group Meeting, Networking and Dinner at local restaurant. You can choose 1, or all of the above. Location and Hotel Hotel BLOOM! Brussels Rue Royale 2015 Koningsstraat Brussels, Belgium The Leading Minds Seminar has a negotiated rate of / night for bedrooms.

3 3 Leading minds seminar brussels, BE april 2016 Tuesday April 12 th Seminar Presentation and Discussion Topics Welcome Coffee Leading Minds FUELS the Cold Chain Industry Colleague Team Building 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) Interpretation of GDP for Temperature Sensitive Shipments in the Pharma Supply Chain Steve Winyard, Pharma Cold Chain Industry Expert, Envirotainer Networking Break Setting up a Global Data Monitoring System: Preparing for Shipment Analytics Wim Vangoidsenhoven, Independent, Transportation and Cold Chain Practitioner 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 Lunch Five Minute Recap and Summary on Problem Solving Group Discussions 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 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 Networking Break 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 Community Forum Discussion: Stability Budget Approaches FUEL Session Industry Team Building Closing Remarks Networking Drinks Reception Dinner Bringing together the best minds from pharmaceutical manufacturers and supply chain partners; Participants will enjoy networking with other temperature control logistics and QA professionals during informal discussions, luncheon and networking evening in Brussels, Belgium. The seminar is complimentary (no fee) attendance to pharma ceutical manufacturers.

4 4 Leading minds seminar brussels, BE april 2016 Wednesday April 13 th User Group Meetings (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 cbecker-james@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 Monitor ing 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

5 5 LMS_Brussels_2016_V1E About the Seminar Hosts For nearly 30 years, ELPRO has been a leading Swiss manu facturer 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. ELPRO s US subsidiary has been established in Marietta, OH since 2003 with a full turnkey support and technical staff. Envirotainer is an industry leader in active temperature-controlled containers for air cargo on a rent-it-whenyou-need-it-basis, in an open-platform global network. We also offer related services that ensure correct temperature throughout the transportation from loading to delivery. No matter how long the journey, or whether cooling or heating is the key requirement. In the industry this is called an unbroken cold chain. Envirotainer is a Swedish company, and all production and development takes place in Tallbacksgatan 12, Rosersberg, located between Stockholm and Uppsala. But our business is truly international. One of our greatest competitive advantages is our global network of partners within the freight forwarding and airline industries, as well as our presence at most of the world s major airports. We also have our own operations centers in Singapore, Dallas and Frankfurt.