Sponsored webcast: Navigating the Future: Trends in Plain Language Summaries and Regulatory Intelligence (On Demand)
The landscape of clinical trial disclosures is rapidly evolving.
This session will delve into the latest trends in plain language summaries (PLS) and regulatory intelligence, offering insights into the increasing demands for transparency, the integration of real-world evidence (RWE), and the challenges of adaptive and decentralized trials.
Attendees will explore how regulatory support and digital dissemination strategies reshape clinical trial communications. With a focus on practical approaches to compliance and patient-centric communication, this session is designed for regulatory professionals seeking to navigate the complexities of clinical trial disclosure in the global arena.
Registration Fees & Deadlines
Learning Objectives
- Understand the current global trends driving the adoption of plain language summaries and their impact on regulatory practices and patient engagement.
- Explore the evolving regulatory landscapes in emerging markets and the importance of nuanced compliance strategies.
- Examine the role of digital platforms and multimedia in enhancing the accessibility and effectiveness of clinical trial summaries for diverse populations.
- Assess the implications of non-compliance with trial registration and results reporting, including penalties and enforcement actions.
Who Should Attend?
- Regulatory affairs professionals
- Clinical operations managers
- Medical writers
- Data disclosure and transparency leads
- Quality assurance and compliance specialists
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
Thomas Wicks
Head of Transparency Operations, Citeline
Thomas Wicks is an industry leader in clinical trial transparency and disclosure. As head of transparency operations at TrialScope, a Citeline company, he spearheads strategy and operations for the company's transparency solutions. Leveraging over 20 years of experience in life sciences compliance, Thomas tracks emerging regulations and data-sharing trends to advance TrialScope's offerings. He provides guidance on best practices for clinical trial disclosure, drawing on his deep expertise built since 2007.
Francine Lane
Senior Director of Product Management for TrialScope Disclose,Citeline
Francine Lane is the Sr. Director of Product Management for the TrialScope Disclose products and the chair of the DIA Clinical Trial Disclosure Community. Francine has worked with clinical trial disclosure and transparency since 2005. She is responsible for helping TrialScope Disclose customers meet and exceed current disclosure expectations globally, giving them the tools they need to meet all the requirements in this evolving industry. Francine also dedicates her time building relationships with external stakeholders — including sponsors, investigators, regulators, and transparency and patient advocates — to help align the goals and expectations of these groups, as well as help identify more consistent ways sponsors can meet industry standards.
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
