Presentation by Kimby Barton, Director of the Health Product and Licensing Division (HPIL), Health Products Compliance Directorate Health Canada’s Regulatory Operations and Regions Branch

• What we are seeing in terms of compliance and areas for improvement
• Performance statistics
• Upcoming guidance documents for consultation
• International collaboration and harmonization
• New regulatory packages and implications for industry

The National Cyber Forensics and Training Alliance (NCFTA) was established in 2002 as a non-profit partnership between private industry, government and academia to provide a neutral, trusted environment that enables a two way collaboration and cooperation to identify, mitigate an disrupt cyber crime. 

1. View NCFTA research on the online availability of pharmaceuticals including cold chain products on domains and trade sites, highlighting alleged available “stealth” or “discreet” shipping and the potential delays in shipments that could affect the integrity of the supply chain
2. Describe the potential risks and implications posed by cybercriminals to the supply chain as well as provide an overview on threats posed by zerodays, malware, IoT vulnerabilities and other system issues that could affect the logistics and transactional steps involved
3. Include how to follow transactions, evaluate vendor profiles, the challenges posed tracking cryptos, and a review of the use of the dark web by criminals

Presentation by:

• Cliff Riggs, Intelligence Analyst III, The National Cyber Forensics and Training Alliance (NCFTA)
• Stephanie Walker, Intelligence Analyst, The National Cyber Forensics and Training Alliance (NCFTA)

The notion of the “Supply Chain 4.0” proposes a plethora of new digital solutions for the pharma market to adopt including EWM, Cost Design, Integrated Business Planning, Web Barcodes, IOT, Blockchain, AI, and Cloud-based Solutions to optimize the supply chain. With all of the new technology for integration, it is imperative to become more digitized. What can we do in the Canadian Market to become more integrated in the digital world?

• What is the Industry 4.0 and will it remain a game changer for the entire supply chain?
• How close are we to the Digital Supply Chain?
• Discussing processes for digitalization transformation
• Integration of the end –to- end Canadian supply chain Practical Module:
• How can we integrate the supplier through to the customer in an truly networked supply chain?

Presentation by Dave Malenfant, Director, Center for Supply Chain Innovation, Texas Christian University

Presentation by Shital Parik Mars, Chief Executive Officer, Progressive Care

Shital Mars is the Chief Executive Officer of Progressive Care, a personalized healthcare services and technology company. Under her direction, Shital has guided Progressive Care and its wholly-owned subsidiary PharmCo LLC on a rapid growth trajectory with the signing of an investment deal with The Benchmark Company in June 2018 and the acquisition of Touchpoint pharmacy. 

• Creating and implementing systems that help improve patient adherence and provide risk management practices for physicians and providers.
• Applying digital technologies to gain increased visibility into supply chain operations and make better and faster decisions
• Combatting the nationwide opioid epidemic through a campaign designed to educate patients, physicians and providers on pain management alternatives

• With new and emerging technologies how will or can this change the way we qualify routes and or validate shippers?
• Do we foresee how regulations may change as new and emerging technologies are implemented throughout or supply chains?
• How can new and enhanced temperature data monitors better serve manufacturer-to-patient supply chain controls?
• How is drone technology best used in different regions?

Presentation by Nedal Ismail, Professor and Program Coordinator, Bachelor of Commerce, Supply Chain Management &Management Studies, The Business School, Humber Institute of Technology & Advanced Learning

With regulators across the globe becoming increasingly interested in how organizations are controlling the variables when distributing CRT/Ambient products, companies must re-assess their processes to ensure compliance. Even if total temperature monitoring is not required by regulators, it is crucial to show that you have strong processes in place to stay off their radar. Regulators want to see that you have your documentation in order for these products and have a full understanding of your transport process.

• Calculate accurate temperature profiles for ambient products and properly analyze data collected
• Understand the environment where your products will be traveling and how to best control the elements
• Define your routes through qualification & validation of shipping lanes and profiling using historical data
• Pinpoint the packaging required to seamlessly ship ambient products globally and where a more custom design is needed
• Discuss the global GDP landscape for CRT products and where your products get flagged more often

Presentation by M. Dave Malenfant, Director, Outreach & Partnerships, Center for Supply Chain Innovation, Neeley School of Business