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Omni Shoreham Hotel

Sep 22, 2014 8:30 AM - Sep 24, 2014 1:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

EDM and ERS 2014

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Session 6 Track 2 - Implementation of Regulatory Information Submission Standards (IRISS)

Session Chair(s)

Lenore Palma

Manager, New Technology

Beigene USA, Inc., United States

Change continues to happen with the implementation of regulatory information submission standards. Are the processes at your company current regarding existing standards? Do you know what new standards are on the horizon? Have you begun to plan and make changes internally within your company to meets these new standards? Members of the IRISS Forum regularly discuss these types of questions. Using a global sounding board of expert advice and experience from peer-based IRISS topic groups, discussions focus on ways to achieve successful regulatory applications and proactively address implementation issues.

Speaker(s)

Gina Ross

Publishing Regulatory Dossiers: Swimming Upstream to the Beginning

Gina Ross

Cardinal Health, United States

Managing Director, Regulatory Submissions & Admin Ops, Regulatory Sciences

IRISS GSO Surveys: Publishing Best Practices, Issues and Trends

Marlene A. McCallum

Spectrum Pharmaceuticals, Inc., United States

Senior Electronic Submissions Manager

Preparing for the Module 1 Version 2.3 Update – Questions Addressed During IRISS Forum Topic Group Meetings

Jennifer Ann LaFleur, MS

Boehringer Ingelheim Pharmaceuticals, Inc., United States

Associate Director, Global Submission Management

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