Speakers from Bayer Healthcare, the U.S. Pharmacopeia, Fisher BioServices, and Novartis Pharmaceuticals will be among the presenters at Cold Chain IQ and IQPC's BioLogistics Summit.
The two-track event, which runs June 3-5 at San Francisco’s Golden Gateway Hotel, will examine “Regulatory Compliant Transportation and Management of Biological Materials, Clinical Specimens and Infectious Substances.”
Because of globalization and supply chain complexity, the pre-market environment for biologics and clinical trials is undergoing major changes. More and more companies are outsourcing non-core competencies and are actively exploring new areas such as personalized medicine. All of this change leads to regulatory uncertainty, and with costs continuing to rise, the logistics of clinical trial supplies are more critical than ever.
The 2013 Summit will include case studies, best practices, round tables, and panel discussions during a two-track event that will cover topics such as:
• Personalized medicine logistic challenges
• Temperature management strategies
• Regulatory requirements for storage
• Comprehensive product management for clinical supply distribution
• Vaccine storage at temperature ranges
• True costs of clinical trial delays
• Preventing temperature swings through reusable shippers
• Large-scale cryo-vessels
• Returns for biologic products
• Reverse pharma logistics for clinical trials
• Combination product complexities
• Set-up and management of clinical trials
• Optimal packaging for your finished biologics products
• International shipping of temperature control clinical kits
• California e-pedigree requirements
• Best practice approach to quality systems and controls
• Collaboration with contract manufacturers, contract research and testing labs
• Fully versus partly outsource supply chain model
• Lithium battery risks shipping air freight
• Importation practices for your clinical materials
