Globalization is increasing the complexity of regulatory content management. Learn how one company designed and implemented an affiliate-friendly global system for content distribution and tracking and how you can make that lesson work for your organization. Andy Harrison, manager of regulatory operations, Biogen Idec, will share how his company decided which attributes to gather, what information to report, and whether to send tasks to one or more recipients in each country.
Lalana Dararutana, senior consultant, Veeva Systems, will cover the key objectives and considerations for building global systems that meet headquarters’ needs and will be readily adopted by affiliates. Speakers will outline recommendations and questions to guide internal conversations around process efficiency and system usability.
Learning Level(s): Basic/Intermediate
Upon the webcast's conclusion, you will be able to:
- Improve usability and adoption of global systems
- Ensure the use of current approved materials at all times
- Increase visibility of regulatory documentation sent to local health authorities
Who Should Attend
- Business or IT leads for regulatory systems
- Regulatory personnel responsible for coordinating with regional offices or local affiliates
- Anyone involved in implementing or expanding global systems
Andy Harrison,manager of regulatory operations, Biogen Idec.
Andy Harrison is manager of regulatory operations at Biogen Idec (www.biogenidec.com). He works with development to create and manage regulatory submissions for the company's product portfolio. Harrison is the business lead for developing a new document distribution and tracking systems for affiliates and distributors. Harrison has more than 18 years of experience in document management and submission publishing systems, such as system implementation, validation, administration and running a global publishing group. He has worked in multiple settings, ranging from large pharma and small biotech to healthcare, CRO and software companies specializing in document management and submission publishing.
Lalana Dararutana, senior consultant, Veeva Systems
Lalana Dararutana is a senior consultant in the Veeva Vault R&D services and consulting practice, where she leverages her industry and best practices knowledge to lead clients in the rapid configuration and implementation of Veeva Vault. With more than 10 years of expertise in regulatory affairs and regulatory operations, Dararutana is well-versed in global regulatory requirements, compliance considerations and processes for submission management. She has led operational change management initiatives, business analysis projects, process modeling efforts and implementations of content management systems for life sciences. Darautuna is a member of special interest and standards organizations such as Institute for Research in the Social Sciences.