Expert-led sessions for professionals involved in clinical and regulatory writing
Upcoming session:
Clinical Trial Report Writing Under New Regulatory Requirements: Navigating EUCTR, ICH M11, EMA Policy 0070, and Beyond
Thursday, October 8, 2026 · 9:00 AM EST
Bioforum’s Medical Writing Expert Sessions are designed to support professionals who author, review, or contribute to clinical and regulatory documents across the drug development lifecycle.
Led by Bioforum’s Medical Writing team, this series covers practical topics that shape high-quality regulatory writing, from study design fundamentals and evolving guidelines to data interpretation, document strategy, and collaboration in complex writing projects.
These sessions are offered at no cost and are intended to create a focused, high-value learning experience for a curated audience of professionals across clinical development.
What are the Medical Writing Expert Sessions?
The Medical Writing Expert Sessions are a series of professional discussions led by Bioforum experts and designed to help participants strengthen the quality, clarity, and effectiveness of clinical and regulatory documents.
Topics will vary throughout the year and may include foundational and advanced subjects relevant to medical writers and cross-functional stakeholders involved in regulatory documentation.
Each session is designed to be practical, focused, and directly relevant to real-world writing and document development challenges.
Who is this program for?
These sessions are intended for professionals involved in authoring, reviewing, or contributing to clinical and regulatory documents, including:
- Medical Writers
- Clinical Scientists
- Regulatory Affairs professionals
- Clinical Operations professionals
- Teams contributing to protocols, CSRs, ICFs, IBs, and submission documents
- Professionals looking to deepen their regulatory writing expertise
Some sessions may be more relevant to junior or developing medical writers, while others may be geared toward more experienced professionals or specific document types.
What you can expect to gain?
- Practical writing approaches that can be applied immediately
- Greater clarity on regulatory expectations and document strategy
- Stronger ability to interpret and communicate complex clinical information
- Better consistency, scientific rigor, and storytelling in data-rich documents
- Useful perspectives that support more effective writing collaboration across teams
Whether you are working on protocols, clinical study reports, informed consent forms, investigator brochures, or submission sections, these sessions are designed to strengthen both writing quality and document thinking.
Meet the presenter
Shiri Diskin, PhD
Chief Medical Writing Officer, Bioforum
Shiri Diskin holds a PhD in Cell, Molecular and Developmental Biology from Tufts University and has worked in medical writing since 2009. She served as a medical writer and team leader at Teva before continuing her career as an independent medical writing consultant and instructor.
She brings extensive experience across early and late-stage product development, with expertise spanning study-level documents such as protocols and clinical study reports, as well as program-level documents including investigator’s brochures and summaries of efficacy and safety.
Shiri works closely with cross-functional clinical development teams, including safety, biostatistics, and data management, to deliver clear, high-quality, regulatory-compliant documents. In addition to regulatory writing, she is also an expert in scientific publications and has led workshops for physicians and scientists. Her book on scientific writing was recently published worldwide.
View recordings of our previous sessions:
Session 1: Clinical Development Demystified: A Medical Writer’s Guide to Study Design Webinar Registration
Session 2: Navigating the New Era of Protocol Writing: ICH M11 and CeSHarP
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