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Agenda (Start time: 9am EST / 2pm UK / 3pm CET)

Time Session Speaker
2.00-2.10 Introduction & The New CARA Workspace Generis
2.10-2.30 Reimagining the End to End Regulatory Affairs Process Caroline Masterman-Smith, Senior Manager, Technology & Innovation, Syneos Health
2.30 – 2.50 Implementing the Future Now Eric Cardwell, Director, Regulatory Information Management & Lifecycle Management, Abbvie
2.50 – 3.10 CARA for Regulatory Affairs Max Kelleher, COO, Generis
3.10 – 3.30 Managing Global Regulatory operations across multiple companies and affiliates – challenges and successes William Hannon, Senior Director, Otsuka
3.30 – 3.50 Strategies to Manage Complex Migrations to CARA Frank D’Entrone, President, fme US
3.50 – 4.00 BREAK BREAK
4.00 – 4.15 Navigating the Labelling Jungle – how CARA and process improvements can help James Kelleher, CEO, Generis
4.15 – 4.35 Looking at the industry: IDMP, Structured data, PQCMC – where we are now and where it is heading. Remco Munnik, Associate Director, Iperion
4:35 – 4:50 PDFReady – Cure PDF issues to enhance submission readiness Debbie Stanier, Senior Director, AstraZeneca
4.50 – 5:10 How are people getting value from emerging technology investment in RIM / How are companies connecting up across the enterprise (Clin, PV, Safety etc) Steve Gens, Founder, GENS & Associates
5.10-5:50 Panel of Regulatory Experts – what we want from RIM Leonard Lescosky, Vice President, Regulatory Operations & CMC, AbbVie
Debbie Stanier, Senior Director, AstraZeneca
Remco Munnik, Associate Director, Iperion
William Hannon, Senior Director, Otsuka
Steve Gens, Founder, Gens & Associates
John Cogan, Executive Managing Director & Global Practice Leader, Syneos Health
5:50-6.00 Close Out Generis