Regulatory compliance is a critical aspect of the pharmaceutical and life sciences landscape. Maintaining GMP/GDP and other industry standards requires dedicated knowledge and regulatory expertise to manage timelines and quality control. As the supply chain becomes more complex, the greater the challenges to managing compliance and developing systems for data collection. When it comes to meeting regulatory standards, being prepared is integral to success and failure is a loss of resources.
Current events play a key role in developing a strategic policy, and sanctions, embargoes and international emergencies affect the response to regulatory compliance. Mitigating risks, avoiding violations and streamlining mandatory processes are paramount to creating an operational protocol for building reliable global pathways.
Join the featured speaker, a Certified Customs Specialist and regulatory expert, in this informative webinar to learn how being prepared for regulatory challenges can improve the time it takes to bring a product to market, increase market share and reduce risk of infractions that jeopardize success.
Reynaldo Roman, Senior Director Regulatory Compliance, Marken
Rey Roman 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 US Customs brokerage and trade compliance which included managing Custom’s brokerage teams and aiding US 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.
Anna Cesar, Manager Regulatory Compliance EMEA, Marken
Anna has over 14 years of experience in regulatory and trade compliance with a demonstrated history of working in the logistics and supply chain industry. Based in Latin America, she has held a variety of roles from operations through high-level management across cross-functional departments, gaining expertise in training and development, data analytics, quality management and contingency planning. In her current role at Marken, she provides expert regulatory oversight of critical shipments throughout Europe, the Middle East and Asia.
Who Should Attend?
Senior professionals who are involved with:
- Supply Chain Managers
- Logistics Managers
- Trade Compliance Specialists
- Procurement Specialists
- Pharmaceutical Companies
- Biotechnology Companies
- Central Labs
What You Will Learn
In this webinar attendees will learn about:
- Regulatory effects on global clinical trials and distribution
- Keeping up to date with changes in import and export controls
- Successfully managing supply chains through regulatory difficulties
- Leveraging technology to record and transfer data
Challenges and Considerations in Regulatory Affairs
- Dedicating resources to ensure regulatory compliance
- Aligning maintenance and data collection for the future
- Pressures of geopolitical disruptions, virus outbreaks and economic instability
Strategic Approach and Innovative Solutions
- Moving from a reactive to a proactive quality program
- Processes to support accelerated trial timelines
- Being ready for audits and global trade
- Creating a built-in regulatory compliance system
- Adopting technology to enhance regulatory processes
Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. 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 58 locations worldwide, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 1,900 staff members manage 120,000 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.