Sponsored Webcast: Impact of International Regulations on Health Literacy and Clinical Trials (On Demand)
New European Union regulations recommend that plain language versions of clinical trial results and protocol synopses be made public. At this webcast, presenters will discuss EU clinical trial regulations, the unique challenges of creating plain language documents for them, and the potential use of these documents to increase health literacy around clinical trials. These include:
- Increased transparency and trust in medical research.
- Improving organizational health literacy of clinical trial sponsors.
- Encouraging collaborative efforts between clinical trial sponsors and patient advocates.
- Empowering patients to make informed decisions about newer medical treatments and enrolling in clinical trials.
- More equitable access to clinical trials
Registration Fees & Deadlines
Learning Objectives
- Identify the major design control elements and understand their contribution to the development of safe and effective medical devices.
- Understand how human factors fit into product development and design controls.
- Outline and describe the costs associated with human factors studies.
- Develop strategies for identifying device users, user environments and critical tasks.
- Identify methodological differences between generative, formative, and validation/summative studies.
- Be able to make decisions based on results from human factors studies and document them in the usability engineering file.
Who Should Attend?
- All regulatory affairs professionals o Product and submission team leads
- Project Managers
- Regulatory and Medical Writers
- Medical and scientific publishing writer
Audience 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.
Speakers
Laura Sheppard, MBA, MA
Sr. Director, Regional Head Clinical Regulatory Writing and Lay Summary Team Lead, Certara
Ms. Sheppard is a medical writer with experience in document quality control, project management, and clinical transparency and disclosure in both contract research organizations and pharmaceutical environments. In her role at Certara, she supports the regulatory and access organization by leading a team of skilled regulatory writers and collaborating closely with cross-functional teams. She has 20 years of experience in translational science, clinical development, and clinical operations, including 15 years in medical writing, document quality review, and regulatory strategy experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND), New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorisation Applications (MAA) and Clinical Trial Authorization (CTA) applications. Laura served her three consecutive terms with the American Medical Writers Association (AMWA) as a Director-At-Large. She supports her local AMWA chapter as the NJ Program Chair. Her experience in therapeutic areas includes anti-infectives, cardiovascular, central nervous system, endocrinology, gastrointestinal, immunology, nephrology, neurosciences, oncology, pain management, rare disease, respiratory, urology, and xenotransplantation.
Angie Sun, MD
Sr. Regulatory Services Manager, Certara
Angie has eight years of experience in medical writing, document quality control, medical review, and project management. With a background in healthcare and medicine, she has leveraged her medical knowledge to produce clinical and safety regulatory documents, with a focus on creating patient-centric documents in plain language. She leads a team of regulatory writers and collaborates with global teams in developing plain language documents. She holds a Board of Editors in the Life Sciences (BELS) certification.
