AMWA Carolinas 2026 Spring Conference

Conference: AMWA Carolinas 2026 Spring Conference

日期： 2026 年 5 月 15 日

地点： North Carolina Biotech Center. Durham, NC

Transforming drug discovery and development for good

At Certara, regulatory science sits at the core of drug development — integrating predictive simulation, advanced modeling, and AI to inform smarter decisions from early development through submission and approval.

我们秉持宏伟愿景：to transform your development process and bring greater certainty to regulatory outcomes.

Where to hear Certara insights and expertise

2026 年 5 月 15 日

Lay Language Updates for 2026 and Beyond

Presenter: Laura Sheppard

The evolving regulatory landscape for lay language deliverables creates challenges across health authorities and tight clinical timelines. This session explores how to integrate requirements, guide clients on templates, planning, and implementation, and overcome real world obstacles. Building strong lay language foundations helps writers expand skills and support effective, compliant communication.

Laura Sheppard, MBA, MA

Senior Director, Regulatory Services Management and Lay Language Management Regulatory Science and Medical Affairs

Sheppard 女士是全球申报高级总监兼医学作家，在合同研究组织和制药环境领域的文件质量控制、项目管理以及临床透明度和披露方面具有丰富经验。她拥有 20 年的转化科学、临床开发和临床业务经验，其中包括 15 年的医学写作和监管策略经验，涉及生物制剂和小分子的全球上市申请，以及新药临床试验申请 (IND) 和临床试验授权 (CTA) 申请。

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