Broadcast #2 is identical for this recording.
The logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially when certain regions of the world are included. Underestimating the complexity of the logistics involved in the handling of sensitive and highly regulated materials such as clinical supplies has the very real potential to put patients at risk and jeopardize both the study budget and timeline. Past success managing the flow of clinical supplies in one region does not automatically work in another. From geopolitical and cultural differences, to infrastructure availability and quality, environmental conditions to regulatory requirements, each country, and sometimes regions within the same country, must be considered individually.
Having a thorough understanding of a country’s regulatory requirements is critical. This includes understanding both the written and unwritten regional differences and business practices. Proactive awareness of these differences, which can be subtle, can make the difference between successfully moving clinical supplies between countries or being detained in Customs or rejected entirely.
- Gain awareness of logistics considerations and challenges found within different regions of the world including LATAM, CEE, APAC and MENA.
- Identify those regions which are just beginning to emerge and what foundations are being put into place to support future clinical trial activity
- Understand the basics of VAT/IOR constructs and how to identify all necessary parties and paperwork needed for the successful movement of finished clinical supplies and/or components across boarders
Rognvald Lamb, Global Transportation Manager, Catalent Pharma Solutions
Mr. Lamb has nearly 30 years of distribution and logistics experience across a broad range of industries. For the past 14 years, he has worked in the pharmaceutical industry applying his customs, distribution and logistics expertise to the clinical trial supply chain for a number of global companies including Quintiles, Marken, and Fisher Clinical Services before joining Catalent as Global Transportation Manager in 2015. His career has allowed him to build up in-depth knowledge and hands-on experience of operating and importing into the less developed countries, and with the ability to appreciate and conform to global customs requirements from 8 years’ experience as a UK Customs & Excise Officer.
Who Should Attend?
Senior professionals from Pharmaceutical, Biotechnology and Medical Device manufacturers involved in:
- Clinical supply chain / distribution / procurement
- Clinical packaging / labeling
- Clinical operations
- Quality assurance
- Regulatory affairs
Catalent Pharma Solutions
A global leader in Clinical Supply, Catalent partners with sponsors to accelerate and scale their trials with innovative, flexible and reliable supply solutions. Catalent provides comprehensive and integrated services for sponsors and studies of all sizes. We offer full-service packaging, cold chain distribution and specialized capabilities across the globe to solve clinical supply challenges.