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 |