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Disney’s Coronado Springs Resort

2024 年 03 月 06 日 7:00 上午 - 2024 年 03 月 08 日 12:30 下午

1001 West Buena Vista Drive, Lake Buena Vista, FL 32830, USA

Medical Affairs and Scientific Communications Forum

3 Tracks (Medical Communication, Medical Writing, and Field Medical) + 1 Location = A cross-functional experience for knowledge sharing, integrated thought leadership, and proactive networking.

Session 8 Track 2: Overview of Recent Changes in Clinical Trial Guidelines and How to Enhance Medical Writing Impact

Session Chair(s)

Blake  Schouest, PhD

Blake Schouest, PhD

Scientific Medical Writer

Aroga Biosciences, United States

This session will highlight recent changes to regulatory guidelines that will modernize how clinical trials are conducted and reported. Key changes that will impact the functions of medical writers relating to safety reporting, informed consent, maximizing patient engagement, decentralized trials, digital health technologies, and data disclosure will be discussed. Presentations will cover proposed updates in the ICH E6(R3) Good Clinical Practice guideline and clinical trial data disclosure requirements in the Clinical Trials Information System (CTIS).

Learning Objective :
  • Discuss the changes to guidance and explore the impacts to clinical trial development and conduct, meaningful patient engagement, and content creation
  • Identify opportunities in which medical writers can drive innovative trial design, improve patient engagement, and ensure data integrity and quality outcomes
  • Recognize anticipated changes to disclosure of clinical data and interpret the impacts of these requirements on medical writing activities

Speaker(s)

Jane Elizabeth Myles, MSc

Modernizing Trials: Digitizing Design and Delivery

Jane Elizabeth Myles, MSc

Decentralized Trials and Research Alliance, United States

Program Director

Andrea  Clark, PhD, MSc

Adapting to ICH E6(R3): Regulatory Medical Writing in an Evolving Clinical Landscape

Andrea Clark, PhD, MSc

Aroga Biosciences, United States

Senior Regulatory Medical Writer

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