Regulatory Changes Post-Brexit That Impact the Supply Chain

Life Sciences, Clinical Trials, Pharmaceutical, Pharma Manufacturing & Supply Chain,
  • Tuesday, February 16, 2021

At the beginning of 2021, the United Kingdom officially withdrew from the EU customs union. Join Marken’s experts in this webinar to explore the full regulatory impact of Brexit on the supply chain. Understanding the implications for trade strategy, imports and exports, free trade agreements, duties and taxes, and more will minimize delays and ensure compliance.

In this webinar, speakers will present updates on regulatory requirements needed to seamlessly move goods between the U.K. and the EU, as well as how to optimize localized distribution options to minimize risks and delays. The experts from Marken will also discuss strategies for meeting and completing import requirements for investigational medicinal products (IMPs) or clinical drug products and securing required CE mark for products sold in the EU to comply with health, safety and environmental protection standards as well as guidance on EU medical device regulation (MDR), registration and compliance.

Register for this webinar to learn more about the regulatory impact of Brexit on the supply chain.

Speakers

http://Reynaldo%20Roman,%20Marken

Reynaldo Roman, Senior Director, Regulatory Compliance, Marken

Rey Roman, Senior Director of Regulatory Compliance, is a licensed US Customs Broker and a Certified Customs Specialist with over two decades of experience in the industry. In his current role, Rey manages Marken’s trade compliance programs, ensuring that global trade regulatory requirements are met.

Prior to joining Marken, Rey developed a career in U.S. Customs brokerage and trade compliance which included managing Custom’s 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.

Message Presenter
http://Paul%20Aime,%20Marken

Paul Aime, Regulatory Compliance Associate, Marken

Paul Aime is a Regulatory Compliance Associate. Prior to Marken, Paul built his career as a trade compliance specialist in the pharmaceutical industry. He has expertise in import and export compliance, supply chain logistic and warehousing. Paul is a graduate of Universite de Nice France, where he studied Business law and International/Business Management. He currently resides in Cambridge UK.

Message Presenter
http://Anna%20Cesar,%20Marken

Anna Cesar, Regulatory Compliance Associate, Marken

Anna Cesar is a Regulatory Compliance Associate. Anna has over 10 years of trade compliance and logistics experience. Having started her career is Brazil, Anna has developed specialized expertise in trade compliance in Brazil as well as Latin America.

Message Presenter

Who Should Attend?

Senior professionals who are involved with:

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Central Labs
  • CMOs
  • CROs
  • CDMOs

What You Will Learn

In this webinar, participants will learn about:

  • Updates on regulatory requirements needed to seamlessly move goods between the U.K. and the EU
  • Optimizing localized distribution options to minimize risks and delays
  • Meeting and completing import requirements for investigational medicinal products (IMPs) or clinical drug product
  • Securing required CE mark for products sold in the EU to comply with health, safety and environmental protection standards
  • Guidance on EU medical device regulation (MDR), registration and compliance

Xtalks Partner

Marken

Marken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS Healthcare division staffs 128 locations with 5,500 employees worldwide. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 56 locations worldwide, while maintaining the leading position for Direct to Patient and Home Health care services, biological sample shipments and biological kit production. Marken’s dedicated 1,600 staff members manage 100,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken’s unique position in the pharma and logistics industry.

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