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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly but are often overwhelmed with the “who’s and “how’s of the cumbersome and costly efforts to meet these requests. With time working against them, they must 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 is important that documents contain optimal data formatting and presentation from the start. This presentation will explain how the use of advanced technology and automation allows for the production of clinical documents with future disclosure in mind. The program will cover how “transparency-friendly” presentation standards can be integrated into your process beginning from initial medical writing using patient narratives as a case study. The presenter, a narrative, transparency and disclosure expert, will discuss the possibility of producing of clinical documents in both original and anonymized versions at the same time, thereby eliminating the ‘whos’ and ‘hows’ of meeting transparency requirements and reducing downstream costs later.
Upon completion of this program, participants will:
Industry personnel involved in the following roles:
Presenters:
Gabriella Mangino, Product Manager, Certara Synchrogenix
Gabriella Mangino has years of patient narrative production and project lead experience in the pharmaceutical industry. As a product manager at Synchrogenix. She works with the commercial and services groups to help develop and improve the software that supports the company’s technology-enabled authoring capabilities, including anonymization and redaction.