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FREE WEBINAR: Maximize Collaboration for Successful ISS/ISE Development: Strategies to Leverage Cross-Functional Expertise and Stay on Track

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  • Date: Wednesday, July 24th 2024
  • Time: 10 AM · EST (4 PM CET)
  • Webinar description:
    • Integrated summaries of efficacy (ISE) and safety (ISS) are required parts of NDA/BLA submissions as valuable tools for presenting and understanding the safety and efficacy of the product. Efficient and effective development of ISS and ISE involves multiple functional stakeholders. In this webinar, our experts from statistics, project management and medical writing will discuss the core principles of data pooling strategies and share best practices for effective collaboration on ISS and ISE development across functions.
  • Agenda:
    • Importance of pooling data, core considerations on best practices for pooling data
    • Placement of the ISS/ISE reports in the eCTD, relevant guidelines, document formats
    • Development process overview, including FDA discussions and their effects on timelines and key relevant stakeholders within the sponsor and CRO

Short overview of presenter’s experience:

Shiri Diskin, Ph.D, Chief Medical Writing Officer

Shiri has over 15 years of experience as a professional medical writer, medical writing instructor (most recently at the Tel Aviv University faculty of medicine M.Sc. program in regulatory science) and medical writing leader. Shiri graduated with a PH.D. in molecular Biology from Tufts University in Boston and joined Teva Pharmaceuticals as a medical writer. Following her time at Teva, Shiri worked as a freelancer for while, and in 2018 has established the medical writing department at Bioforum.

Adri Erasmus, Senior Director, PMO

Adri Erasmus brings over a decade of expertise in Clinical Data Management with a focus on program and project management. In her current role, Adri oversees the Project Management function, overseeing a team committed to high-quality, on-time deliverables. She is responsible for supporting collaboration and communication across stakeholders to achieve project milestones.

Ofra Barnett, Ph.D, Senior Biostatistician

Ofra Barnett-Griness obtained her Ph.D. in Statistics in 1998, after which she has been working within the pharmaceutical industry providing statistical expertise in various strategic roles across multiple therapeutic areas, focusing on Oncology.  Ofra joined Bioforum in June 2019, to provide statistical leadership for overall and individual study strategy for our customers. She consults on aspects of study design, endpoint selection, sample size considerations, and advance statistical methodology. These incudes regulatory with FDA and other agencies. Ofra gained experience in teaching statistics where she aims at bringing the valuable biostatistics concepts and tools to the statisticians and non-statisticians audience.




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