This presentation explores the Health Canada Guide-00069 regulations and requirements in Canada and provides detailed examples of compliance and non-compliance regarding:
- Review guidelines for products in transit: stability data requirements and temperature mapping
- Discus the regulatory scope of temperature monitoring for CRT
- Risk valuation and mitigation and analyze examples of compliance and non-compliance
- How to implement locally to distribute to Canadian customers to fulfill authority requirements
- Discuss the global regulatory landscape for CRT products and where they may get flagged
Tonino Antonetti, M.Sc., Executive Director, Regulatory Affairs & Quality Management -SHE, Roche Diagnostics
Rafik H. Bishara, Ph.D., Technical Advisor & Former Director QKMTS, Eli Lilly and Company (retired)
With the variety of product lines increasing and the regions, companies are shipping to growing. There are a lot of variables to account for when qualifying your shipments. In particular, USA’s vast geography and temperature gradients pose a big challenge for logistics and supply chain professionals. These challenges show direct parallels with the current environment in Brazil. Shipping from South to North Brazil brings about similar roadblocks as shipments to distant US regions. These issues can be mitigated through smart supply chain management, streamlines logistics, and open communication with supply chain partners. What you will learn:
- Qualifying solutions that worked for Brazil national operations
- Establish an evaluation tool characterize your shipping lanes by riskiness and discuss solutions to decrease that risk.
- Review best practices for managing your partner relationships, both local & internationally through the use of correct relationship models
- Where does lane qualification fit into your overall supply chain management initiatives? How do you prioritize?
Luiz Barberini, Operations Manager, External Manufacturing Organization Latin America, Bayer Consumer Health
- Highlights an innovative partnership and solution to provide insulin access to patients in need, through free clinics and charitable pharmacies.
- Objective: Highlight considerations for both Lilly and Dispensary of Hope
Suzette Figueroa Diaz, Director Access & Affordability, Lilly Diabetes
Steve Stapleton, Director Patient Assistance Programs, Lilly USA & President Lilly Cares Foundation
Scott Cornwell, Chief Supply Chain Officer, Dispensary of Hope Eli Lilly and Company & Dispensary of Hope’s Partnership for Insulin Access
One State now requires that a pharmacy shall ensure the integrity of any drug requiring temperature control that is delivered by mail order by enclosing in each package a measurement device to alert consumers that drugs have been exposed to temperatures that could affect their potency and stability. So how has one of the major pharmacy chains decided to meet that requirement?
Alan Kennedy, Founder and Executive Director, PHARMA TEAM-UP
Presentation by Bill Mahorney, Chief, Enforcement Division FMCSA, Department of Transportation
As of December 18th, The ELD Mandate was passed in congress - the new rule mandates any driver required to previously keep a paper record of duty status must install an ELD (electronic logging device) in their vehicle which means instant third party verification that Drivers cannot work more than 14 hours a day and not drive more than 11 hours. It’s an open industry secret that truckers lie about how long they spend on the road. In an industry that already has a crippling shortage of drivers and capacity issues, the bandwidth will now shrink as much as 15% more. As of April 1st – the grace period was over. Bill will be addressing how this will affect the supply chain, logging books, hours of service regulations, and shipping/distributors collaboration with truckers. Bill will tie in Compliance with Collaboration as he details the FMCSA’s role within the new regulations.
- Investing in new tacking systems
- Creating client animosity and delivery limitation
- Moderating the new trucking landscape with third part verification
- Installing Electronic Logging Devices
- What is the concept of product quality and what is the philosophy surrounding quality management in supply chain environment
- Correlation between little q and bigger Q in relation to the product quality and supply chain management and how can they impact each other
- How Q.A and Supply chain can cooperate in an Effective Manner to Ensure Seamless Integration of their efforts in order to achieve the Optimal Quality - Supply Chain Solution to the Customers
- Real examples of successful collaboration approaches between Quality and supply chain department
Ahmed ElSheemy, Head of Quality Assurance Middle East & Turkey, Merck Serono Middle East (a subsidiary of Merck KGaA Germany)
- Discussing Blockchain, IOT, AI, and other technologies will radically transform the Pharmaceutical Cold Chain over the next 5-10 years
- Developing Blockchain Transformation Strategy
- Outlining Blockchain Procurement and Supply Chain Management
- Addressing the Blockchain Transformation of Healthcare
Jack Shaw, Executive Director of the American Blockchain Council, Technology Futurist
- Innovative Reusable Bulk Container for Shipping Drug Substance <-30°C
- Real-Time Supply Chain Visibility to Provide Flawless Performance
Jennifer Antonetti, Sr. Supervisor Global Distribution Packaging & Shipping Qualification, Biogen
Chris Day, Director of Business Development – Leasing Services, Sonoco ThermoSafe
Bayer’s Unique Relationship Model that will Help you Improve Data Exchange, Network Platforms, and Integration.
Ensuring that all products are delivered on time and that no back orders occur, is an essential KPI across supply chain professionals. Bayer is taking the necessary steps to improve data exchangeand supplier network platforms to achieve better integration and create a balance between supplier collaboration, customer collaboration and peer collaboration.
- Invest in correct programs and architecture to allow successful collaboration through joint ventures.
- Improve relationships with all third party suppliers to increase efficiency of your supply chain
- Allude to the effects of Supply Chain 4.0 and how this will affect relationship management of the future
- Formulate strategic models to improve supplier relationships across every point of the supply chain
Presentation by Luiz Barberini, Operations Manager, External Manufacturing Organization, Latin America, Bayer Consumer Health