Tue, July 19th 2022 | 11:00 am ET
In partnership with TOPRA, this webinar will provide insights into how transparency and disclosure efforts are an integral part of medical writing for investigational drug submissions. Typically, sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly. However, they are often overwhelmed with the “who’s” and “how’s” of the cumbersome and costly efforts to meet these requests. They must effectively compile, and re-visit already published documents that may not be “transparency friendly”. Whether anonymizing data for maximum data utility or redacting it as company confidential information, it’s important that documents contain optimal data formatting and presentation from the start.
This webinar shares an overview of how automation using advanced technology, allows the production of clinical documents with future disclosure in mind. Using patient narratives as a case study, we show you how “transparency-friendly” presentation standards can be integrated into your process starting from initial medical writing. Our resident narrative and transparency and disclosure expert, Gabriella Mangino, also discusses the possibility of producing clinical documents in both original and anonymized versions at the same time, facilitating meeting transparency requirements while reducing downstream costs later.
Product Manager, Certara | Synchrogenix
Gabriella Manginoは、患者ナラティブ制作やプロジェクトリーダーとして製薬会社に長年従事してきました。As a Product Manager at Certara | Synchrogenix, Ms. Mangino works with the commercial and services groups to help develop and improve the software that supports our technology-enabled authoring capabilities.