Life sciences companies face mounting internal pressures such as inflation, sourcing and manufacturing uncertainty and ever evolving global regulations. Additionally, internal pressures are calling for teams to operate lean and leverage data to solve problems. Together, these external and internal forces present a new wave of challenges for regulatory affairs and operations professionals, especially when managing a sprawling, global product portfolio.
Fortunately, the rapid pace of technology innovation and emerging global data standards provide industry with a new toolset that can be harnessed to bring drugs to market safely and efficiently while achieving commercial success. Life sciences companies can leverage advanced technologies like artificial intelligence (AI) to reduce manual effort and save time by shifting functions like ingestion and tracking of health authority correspondence from mostly manual to automated. Global data standards like ISO Identification of Medicinal Products (IDMP) and HL7’s Fast Healthcare Interoperability Resources (FHIR) promote quick and efficient exchange of information. Interoperability between systems and regions of the world has great potential to lower the cost of operations and create meaningful connections between functional areas such as regulatory and pharmacovigilance.
Join this webinar as ArisGlobal regulatory leaders highlight the potential of intelligent automation and interconnected regulatory data to inform strategic decisions and other key strategies for proactive management of a global product portfolio. They’ll also share use cases and practical steps that regulatory leaders in life sciences can take to ride the next wave of innovation in technology and global data standards.
Laura Jones, Director, Regulatory Product Management, ArisGlobal
Laura has 24 years of experience supporting a wide array of information systems technologies concurrent with 23 years pharmaceutical and biotechnology Regulatory industry experience. She’s proficient in R&D technologies, such as LifeSphere RIMS, CoreDossier, InSight Suite, ISI Publisher, eCTD Xpress, eCTD Manager, and docuBridge as well as various EDMS administration and implementation activities related to submission and content management. Laura has extensive knowledge of global agency guidance/regulations with a specialty in electronic submissions and submission management and has managed various system design and implementation projects.
Robin Schilling, Associate Director, Regulatory Product Management, ArisGlobal
Robin is a strategic thinker and innovator With 15+ years’ experience managing the strategic development and implementation of global technology programs. She is experienced in regulatory affairs, publishing support and technology operations, including leading and collaborating with diverse, international teams. Her passion is helping individuals and organizations grow and excel by identifying opportunities to create value and optimize process efficiencies while remaining compliant with regulatory expectations and good ethical practices. She is a member of EMA SPOR Task Force and an active participant in the IRISS IDMP Working Group.
Renato Rjavec, Director of Products, Amplexor Life Sciences
As Director of Products, Renato Rjavec is responsible for Amplexor’s Life Sciences Solution Product Management. Over the last 15 years with the company, he held several positions within the delivery and product management organization where he acquired broad experience in analyzing, designing and implementing end-to-end regulatory solutions.
Who Should Attend?
- Chief Information Officer (CIO)
- Global Head of Regulatory Affairs and Pharmacovigilance
- Head of Research & Development
- Head of Regulatory
- VP or Director, Regulatory Affairs
- VP of Director, Regulatory Operations
- Manager, Regulatory Affairs
- Manager, Regulatory Operations
What You Will Learn
Attendees will gain insights into:
- The role of automation in creating efficiencies and reducing costs for regulatory affairs and operations
- How interconnected regulatory data can enable every aspect of life sciences and inform strategic decisions
- Regulatory’s connect to pharmacovigilance and its role in improving patient safety through global product data standards
ArisGlobal is transforming the way today’s most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China.