Regulatory challenges and managing the cold Chain emerging markets
As the BRIC markets continue to mature, interest in new or frontier markets has increased. The key to success in the transport of pharmaceuticals and clinical/biological specimens in these markets is a thorough understanding of regulatory and logistical challenges. The challenges of operating beyond BRICs include an ever-changing regulatory environment and managing the cold chain in areas with poor infrastructure and or extreme climates. The time critical and temperature sensitive nature of clinical trial drugs and specimens require the ability to negotiate these obstacles as quickly and efficiently as possible.
This session will focus on the regulatory and documentation requirements for the import /export of clinical and specimen products, communication with agencies and an overview of the license and permit process. We also outline strategies for helping bring down barriers.
Another focal point of this session will be mitigating the impact of poor infrastructure and maintaining cold chain integrity in difficult climates. We will discuss best route planning and contingency route planning. The presentation will also discuss pre and post shipment preparation and support in order to preserve visibility and control of the supply chain and ensure timely and accurate results within project timelines.
Presented by
Jay Hayer,
Senior Director, Commercial Operations
Jay is a specialist in developing customized supply chain strategies for suppliers of clinical trial supplies. Before joining Marken in early 2004, he spent over 10 years with companies directly involved with key elements of the overall supply chain and is now heading the Global Outbound Solutions Team.
Recent projects have included exports of clinical trial supplies to the following locations: Nigeria, Mali, Uganda, Lebanon, Malaysia, Vietnam.
Jay attended further education at the University of London where he received his degree in Business Economics.
Reynaldo Roman,
Senior Manger Regulatory Compliance
Rey Roman, Senior Manager of Regulatory Affairs, is a licensed U.S. Customs Broker and Certified Customs Specialist with more than seventeen years of experience in the customs brokerage and trade compliance field. In his current role, Rey supports Marken operations and business development teams in ensuring that the import and regulatory requirements set forth by Customs and Border Protection and other government agencies are met.
Prior to joining Marken, Rey built a career in U.S. Customs brokerage and trade compliance which included managing Customs’ brokerage teams and aiding U.S. importers to develop trade strategies and best practices. His experience helps to ensure a smooth import process which will result in a more timely and cost-efficient delivery of our clients’ imports.