随着药物开发行业致力于加速申报进程并提升患者对医疗解决方案的可及性，监管专业人员日益面临借助技术提速的压力。
During this on-demand webinar, Heather Graham, Vice President of Regulatory Science and Medical Affairs at Certara, will facilitate a discussion with industry experts on the current technology landscape, how these technologies can be leveraged to accelerate high-quality, fit-for-purpose submissions, and how effective change management is critical in implementing technology across an organization.
Learning Objectives
- Understand the different types of technology being used to accelerate regulatory submission preparation
- Hear real-life examples of where and how these technologies were leveraged in submission preparation
- Understand organizational change management approaches as new technology is embedded in existing processes
演讲嘉宾
- Aliza Nathoo, Senior Business Transformation Leader, Content Design, Reuse & Automation, Roche
- Angela Winnier, Senior Director, Medical Writing, Pfizer
- Matt Renda, Senior Director, Medical Writing Operations Alexion Pharmaceuticals, Inc.
- Heather Graham, Vice President, Regulatory Science and Medical Affairs, Certara
Who Should Watch?
Regulatory professionals who are involved in regulatory content generation and management in support of regulatory submissions.
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
