DIA Berlin - Clinical & Regulatory Operational Excellence Forum
AMPLEXOR Life Sciences traveled to Berlin this month to participate at the DIA Clinical & Regulatory Operational Excellence Forum. The two-day event sought to develop a closer link between clinical operations and regulatory operations to help meet the ever increasing demands and complexities of modern drug development.
AMPLEXOR Life Sciences Vice President of Strategy, Romuald Braun, and Head of Delivery Management, Tomaz Kobe, spoke alongside F. Hoffman-La Roche Senior Business Lead, Mark Cottingham to deliver an illuminating workshop presentation, “Submission Planning and Control Through a Product Lifecycle, Today and Tomorrow.”
The presentation encouraged attendees to rethink the automation of submission execution. Braun delved into the need to optimize the submission process further while increasing oversight and regulatory compliance and also highlighted how AMPLEXOR’s Life Science Suite can assist in the process.
The DIA program included fascinating talks on ISO-IDMP implementation, clinical data transparency, clinical data mining, allotrope framework architecture, among other regulatory topics, as well as a keynote address on driving efficiency and inspection readiness from Bayer AG’s Vice President of Clinical Project Management in Therapeutic Area 2, Birgit Ruhfus, and ICON’s Vice President of Strategic Regulatory Affairs, Dairine Dempsey.
As opposed to some of its larger events, such as its annual 10,000+ attendee conference, this was a smaller, more exclusive, DIA event designed around learning. AMPLEXOR Life Sciences’ workshop presentation was one of just 12 abstracts selected to “showcase working solutions” from which attendees could “learn from implemented best practices.”
AMPLEXOR Life Sciences is a frequent presenter and exhibitor at DIA events and a long-time partner for programming. The DIA Clinical & Regulatory Operational Excellence Forum was AMPLEXOR’s fourth DIA event of 2017.