09:00-09:30 Registration

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09:30-09:35 Welcome and event introduction

David Judge, Oracle

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09:35-10:00 Is outsourcing dead?

• Perspectives on automation, robotic process automation and artificial intelligence in the pharmaceutical industry

Martin Holm-Petersen, Insife

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10:00-10:25 Automation, Machine Learning, Artificial Intelligence in pharmacovigilance

Phil Tregunno, MHRA

 

10:25-10:50 Driving PV efficiency via automation

• A Proof of Concept

Stefan Knold and Marlene Quitzau, Ferring

 

10:50-11:20 Break

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11:20-11:45 AI in signal detection and signal management

Robert Weber, Oracle

 

11:45-12:10 Next generation ICSR intake

Michael Braun-Boghos, Oracle

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12:10-13:10 Networking lunch

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13:10-13:45 Considering the regulatory framework, audits and inspections of automated systems

• Facilitated round-table discussion with Industry and Authority delegates, sharing current learnings and viewpoints, potential barriers and benefits.

Faciliated roundtable

 

13:45-14:20 Lessons learned from innovation in life sciences

• Building a portfolio of change

Troels Bærentzen, LEO Innovation Lab

 

14:20-14:45 Automating EMA EudraVigilance ICSR download, triage and E2b conversions

Francois Audibert, Vitrana

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14:45-15:20 Break

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15:20-15:45 AI in Pharmacovigilance

• Case study from Astra Zeneca

James Whitehead, Astra Zeneca

 

15:45-16:10 Achieving global benefits of applying automation to integrated processes

• Automating the PSMF as an example

Amina Baljic, Peter Stroyer Pallesen, Insife

 

16:10-16:20 Conclusions / Meeting end

David Judge, Oracle