This presentation explores the Health Canada Guide-00069 regulations and requirements in Canada and provides detailed examples of compliance and non-compliance regarding:
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:
Luiz Barberini, Operations Manager, External Manufacturing Organization Latin America, Bayer Consumer Health
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.
Ahmed ElSheemy, Head of Quality Assurance Middle East & Turkey, Merck Serono Middle East (a subsidiary of Merck KGaA Germany)
Jack Shaw, Executive Director of the American Blockchain Council, Technology Futurist
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.
Presentation by Luiz Barberini, Operations Manager, External Manufacturing Organization, Latin America, Bayer Consumer Health