Pharma and Device Packaging and Labeling West Coast 2019

• Overview of DEA Diversion Control Division
• Insight into drug diversion and connection to opioid crisis
• Exploration of federal regulations around packaging of controlled substances

The regulatory landscape for drugs, biologics/vaccines, and medical devices is ever changing. Structured data submissions of various product information is now the norm and becoming more prevalent with FDA and other regional health authorities around the world. This session will provide an overview of FDA’s use of SPL and summarize current/future global regulatory activities related to product submissions. 

Attendees will learn:

• the current use of SPL by FDA for Drug Establishment Registration and Listing
• the current use of SPL by FDA for Medical Device Unique Device Identification (UDI) Reporting
• the future global regulatory requirements for product reporting

• Introduction to Artificial Intelligence (AI) and  Intelligence Augmentation (IA): A brief history, trajectory, and future perspectives
• Considering future applications of Artificial Intelligence in drug discovery, package design and medicine
• Implications of AI in digital health, medical devices and wearables on packaging and labeling
• Robotics technology & its applications to drug discovery and development
• Running intelligent clinical trials using advanced analytics, machine learning, AI, smart labeling and tracking

• Examining the process of marrying textual and barcoded content to find the ideal labeling outcome
• What steps should companies be taking to ensure the workforce is fully trained on implementing and maintaining UDI requirements?
• How has the introduction of UDI enabled companies to streamline the labeling process and prepare for future changes to device data management?
• Development of new processes and procedures that ensure data is transferred correctly to the FDA

• The drivers of change in the packaging supply chain
• Controlling a global artwork process to ensure efficiency and transparency
• Implementing a GMP compliant artwork process
• Vendor selection, managing outsourcing and developing long term business partnerships
• Identifying how Asset Management and Workflow Techniques improve effectiveness

• Exploring the available technologies for effective packaging forecasting
• How to maximize effectiveness of prediction and overcome packaging challenges
• Practical lessons leant on cost savings and avoiding under supply and wastage -what to avoid in the future when forecasting for packaging and labeling scenarios

• Usability for medical device packaging and its impact on packaging
• Testing and how to integrate its usability testing into design and product development processes
• How to stay fully compliant

Forward-thinking medical device firms are implementing integrated Enterprise Labeling and Artwork Management solutions.  Many are leveraging “validated sources of record” to streamline regulatory compliance, customer and marketing requirements. Integrated solutions reduce packaging revisions while improving time-to-market and ultimately reducing costs.  Hear examples of how automating and centralizing labeling enhances accuracy and eliminates complex, error-prone data replication

• An industry-wide problem: Why packaging design must start earlier in the process.
• When package label differentiation comes into play.
• Package labeling faux pas: Don’t reinvent the wheel.
• When packaging matters in human factors validation studies.
• Generic packaging and package labeling: Imitation is the greatest form of flattery!

Opportunity to hear and learn from 3 selected companies giving a 15 min presentation/case study on the latest developments and innovation in intelligent packaging, packaging materials, labeling, use IoT platforms, blockchain and designing packaging configurations that will align with sustainable logistics

Project 1: The use of Rapid Prototyping, 3D Modeling and 3D printing for packaging design, and the benefits to project schedule and building in house expertise

Project 2: Latest innovation in human factors design

Managing your labelling and artwork management lifecycle effectively and efficiently is key to gaining and keeping your end customer’s trust; whether that’s a doctor, a pharmacist, or a patient. It can also be the difference between life and death. In this presentation we will explore:

• The pitfalls of a poorly managed labelling lifecycle
• The benefits of implementing an end-to-end labelling solution
• The 5 keys to success in executing a labelling management project

• What is needed to create a nurturing corporate environment for innovation within your firm?
• Who is the customer/patient of the future? What do we know about them and how can we respond to their needs through smart packaging?
• How Blockchain and intelligent packaging being used and its potential to change the industry
• How will sustainability, waste management and reusability drive packaging and labeling?
• How to innovate on a small scale when you don’t have large investment behind you

Interactive Think Tank sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Each Think Tank session lasts for 30 minutes, and delegates may attend up to 2 think tank tables. In the end of the session each chairperson will share key findings from the discussions.

Roundtable 1: Mastering labeling and packaging in cryogenic temperatures led by led by Eric Barnitz, Senior Packaging Engineer, Kite Pharma

Roundtable 2: How to develop effective leadership skills and bring out the best in team members led by Led by: Lisa M. Kelsey, Head of Commercial Labeling, Associate Group Director, Genentech

Roundtable 3: Artwork Centralization process led by Sathyanarayanan Krishnamurthy, VP – Regulatory Operations, Freyr Solutions OR

Roundtable 4: Increased Importance of Traceability by Regulators led by Kiran Venkata Satya Chinnalla, Executive Management – Labeling services, Freyr Solutions

Roundtable 5: Errors in labeling – how to overcome these issues and what needs to be done to avoid and improve your processes led by Bruce Suknanan, Manager, Regulatory Labeling, Regeneron Pharmaceuticals

• Definitions and Regulations
• Packaging requirements and best practices
• Testing Requirements

• Clinical development strategy – examining disparities in clinical research
• Scientific insights and personalized healthcare- optimizing clinical outcomes for all patients
• Advance external partnerships – creating a path for more representative patient populations in clinical
• research and evolving the promise of personalized healthcare for all
• Strategies for trial product packaging and supply to engage patient populations – are products reaching patient populations and encouraging patient retention?

• The role of packaging and its impact on products longevity -what is that ideal aging of a medical device?
• How packaging can support durability in devices and how durable, lightweight materials can enhance product integrity
• Assessing the best materials and packaging for protecting products that could meet your company cost effectiveness and environmental aspects

• How to make an impact at every level to create an effective packaging and labeling
• Approaches in advancing your career progression within the pharmaceutical and medical device sector
• How to effectively recruit the best talent into pharma and device packaging and labeling