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The road to transparency: Mastering EMA policy 70 submissions
Discover how to unlock efficient redaction and transparency processes in line with EMA policy 70.
The EMA transparency policy 70 was suspended in 2018 as part of EMA's business continuity plan for its relocation in the wake of Brexit. The suspension remained in effect throughout the COVID-19 pandemic apart from exceptional transparency measures for COVID-19 medicines. Now, nearly five years later, the policy has been re-launched.
While the transparency policy aims to enable public scrutiny and the application of new knowledge in future research, the policy stirs up challenges facing document review teams and organizations as a whole. Applicants are required to redact personal private data (PPD) and commercially confidential data (CCI) from their clinical data documents. The work on each of the different redaction types requires a different process and therefore needs to be take on by different teams, ideally in parallel as there is considerable time pressure.
Key takeaways
Join our insightful webinar, in association with Ideagen PleaseReview, "The road to transparency: mastering EMA policy 70 submissions" where we will delve into the implications of EMA transparency policy 70 and steps you can take to master efficient redactions and submissions.
Ben is a Consultant in collaboration solutions, supporting pharmaceuticals, medical device firms, and CROs to strengthen and streamline their document review processes. Ben’s expertise and guidance helps organizations to reimagine their co-authoring practices, bringing them more efficient and productive document reviews while also improving their regulatory compliance and audit readiness.
His experience with top global life science firms has given him deep insight into the common barriers that can hinder document completion. Ben assists teams of all sizes to overcome these challenges and gain back the time to focus on their lifesaving work.
As VP of Collaboration Solutions at Ideagen, James supports organizations across the Life Sciences industry to radically overhaul their document review processes, empowering them to reach the document completion stage in significantly less time. All while improving their regulatory compliance and audit readiness.
Having worked closely with top global pharmaceuticals, CROs and medical device companies throughout his career, James has a wealth of experience to draw upon when it comes to pioneering change and raising industry standards. He is passionate about helping teams of all sizes to remove common barriers, minimize costly errors and improve document quality, so that organizations can focus on delivering critical therapies to market, faster.