Webinar: Temperature Controlled Supply Chain planning for BRIC Countries and Africa
Sponsored by: Marken
Focused on:
Date: 17th January
Days old: 4768
Time: 15
Regulatory challenges and managing the cold Chain in cross seasonal destinations
Managing the cold chain and cross seasonal distribution of clinical trial drugs and specimens is a significant factor in the process and risks of clinical trials. Presented by sought after conference presenters and authors of industry published whitepapers, Dan Bell and Paddy Hanlon. This session will focus on the key elements of selecting the right logistics packaging systems covering both active and passive solutions, challenges of managing the cold chain in cross climate lanes and the issues in importing / exporting with:
• Brazil
• Russia
• India
• China
• Africa
The case studies that will be discussed will include agency communications, documentation and special handling of high value pharmaceutical products and clinical specimens.
Another focal point of this session will be an explanation of the differences between Agencies and Customs how those differences can have insurmountable results on logistic timelines.
Also covered in the presentation are methods of mitigating the impact of adverse weather, natural disasters and global events that could impact the clinical supply chain and undermine clinical trial timelines and stability lab specimens.
Presented by
Dan Bell,
Director, Commercial Operations & Regulatory Compliance
Dan Bell, Director of Commercial Operations, has led Marken’s operations on the West Coast of the United States since he joined the company in 2003. He is a licensed US Customs Broker and a Certified Customs Specialist with more than ten years of combined education and practical experience in global life science supply chain solutions, with a focus on trade compliance aspects. His clients at Marken include pharmaceutical and medical device companies, Clinical Research Organizations, Central Labs and Contract Manufacturing Organizations.
He has served as a liaison between his clients, customs, and the alphabet soup of regulatory agencies, ensuring the maximum level of compliance with US trade laws and regulations. His knowledge and experience in this area have led to the development of many import strategies that have significantly reduced turn-around times and cost, while ensuring that time-critical objectives have been met or exceeded.
Early in his career, Dan was headquartered in Europe and was responsible for establishing the US entity of a company that developed high technology data loggers. During this assignment, Dan also spent a significant portion of his time in the Asia Pacific region, forming strategic partnerships with contract manufacturing groups and developing a robust supply chain. As with Dan’s experience in the regulatory area, his expertise in temperature logging has been useful as Marken becomes increasingly involved with temperature controlled shipping and storage of critical APIs, fine chemicals, and temperature-sensitive drug products.
Dan graduated from Plymouth Polytechnic (now University of Plymouth) with a degree in Electrical & Electronic Communication Engineering.
Specialties:
Customs Brokerage Compliance,
Designing creative solutions to global logistics challenges.
Motivating staff to excel.
Paddy Hanlon,
Senior Director, Business Development
TBC
Download Slides
Please login to download the slidesKey Learning Objectives
- Selection of optimal shipper packaging for destinations, product, lanes and temperature sensitive drugs
- Regulatory challenges in Brazil, Russia, India, China and Africa
- Taking a global view of your temperature controlled supply chain
- Key elements to consider when planning drug supply programs to Brazil, Russia, India, China and Africa
Audience
- Clinical Operations
- Logistics/Distribution
- Project Management
- Purchasing/Procurement
- QA/QC/Validation
- Supply/Purchasing/Sourcing /Outsourcing Mgmt
- Clinical Trial Design