Complex Cold Chains: Regulatory Challenges of China + Brazil
Learn how the regulatory environments in China and Brazil compare to USA FDA Cold Chain Guidance
📅 Tuesday, March 28, 2023
🕕 12 PM CT | 1 PM ET | 10 AM PST
Join us as global regulatory experts at Modality Solutions walk you through the complex regulatory requirements + cold chain challenges of China and Brazil, and how they differ from the US.
Why Modality Solutions?
Modality Solutions has been a leader in biopharmaceutical cold chain engineering for over a decade, with a team of experts in regulatory affairs and life sciences. Our deep expertise in packaging design, shipment lane validation, drug product simulation testing, and stability studies allows us to provide clients with a comprehensive regulatory approach, ensuring compliance with the latest global regulations. With a focus on global regulatory requirements, our team helps clients navigate complex regulations, seeking out commonalities and optimizing the validation process. We are dedicated to delivering the last mile of the supply chain, providing the continuity and control necessary to ensure successful product delivery to the patient.
Meet the Experts
Your webinar hosts for Complex Cold Chains: The Regulatory Challenges of China + Brazil
Gary M. Hutchinson
Gary Hutchinson is a controlled-environment logistics expert. His time-definite delivery networks deliver products around the world in a regulatory-compliant and cost-effective way. He accomplishes this complex process by understanding environment and infrastructure, designing controls, and creating monitoring systems.
As a leading authority on and expert practitioner of controlled-environment logistics, Gary concentrates on balancing regulatory requirements, business needs, and available engineering technologies into workable business solutions with high reliability and top performance. He is a leading advocate and sought-after speaker throughout the industry on cold chain management, transport validation, carrier performance management, and the implementation of quality systems across the biopharmaceutical supply chain.
Robert Battista provides technical and regulatory guidance for cold chain validation. He has a successful track record with regulatory filings including over 15 successful commercial filings in the US, Europe, UK, and Brazil for biologics and advanced therapies. Robert is an industry expert at validation master planning and implementation during clinical stage, pre-filing preparation, and post-filing/launch changes. His expertise also extends to transport simulation design and Performance Qualification best practices.
Robert has led successful cold chain validation efforts for cell and gene therapies, monoclonal antibodies, antibody-drug conjugates, and small molecules in capsule and tablets. His achievements have led to industry recognition with a speaking role at the 2023 Supply Chain and Logistics for Cell Therapies Summit. Robert’s experience also extends to the execution of clinical trial operations in challenging environments. Most recently he served as a Subject Matter Expert (SME) in the Democratic Republic of the Congo (DRC).
Discover How Modality Solutions Can Help
Develop a full understanding of complex cold chains.