INTEGRATED REGULATORY COMPLIANCE MANAGEMENT
From Document to Submission
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Speakers:
Andrew Marr
Strategy consultant with 27 years in the Pharmaceutical industry in Regulatory Affairs and Regulatory Operations - Marr Consultancy
Paul Ireland
Global Director, Solution Consulting - Liquent
Farouk Bouaziz
General Manager and Sales Director, Europe - Liquent
Christophe Benninghoff
Pre-Sales Consultant
- NextDocs
Orang Gholikhani
Alliance Manager EMEA - NextDocs |
Date/Time:
Thursday, 9 June 2011
1:00 - 5:30 PM GMT
Venue:
Cambridge Golf and Commerce Center
Hemingford Abbots Golf Complex - Mizuno Room
Cambridge Road
Huntingdon
PE28 9HQ
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NextDocs and Liquent are pleased to invite you to a complimentary half-day workshop, covering the hot topics of eCTD / electronic submissions and document management.
Whether you are looking for a software solution that helps you manage, view and publish your regulatory process or planning to outsource your regulatory submissions, this workshop will provide valuable insight.
By attending you will:
- Hear about Information Management processes integration for Life Sciences – from an industry expert's perspective - Andrew Marr
- Learn how to work with eCTD
- Understand why eCTD and Document Management System (DMS) belong together
- Gain insight into Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences
Experts from the leading service and solution providers will share their experience through presentations and live demos. See first hand how easily documents and submissions can be managed using Liquent Insight integrated with the SharePoint-based Document Management System from NextDocs.
Session Agenda:
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Time (GMT) |
Topic |
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12:00 – 1:00 |
Registration and Light Lunch |
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1:00 – 1:15 |
Opening Remarks and Introduction |
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1:15 – 2:15 |
Information Management Processes Integration for Life Sciences – from an Industry Expert's Perspective (Andrew Marr)
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Document and Content Management
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Regulatory submissions and tracking
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Insourcing and outsourcing/ offshoring scenarios
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2:15 – 2:30 |
Liquent - Your partner for all electronic Regulatory Affairs issues
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Short company presentation
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Overview about the product and service portfolio
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2:30 – 2:45 |
Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Orang Gholikhani, NextDocs)
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Company and Strategy Overview
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Document & Quality Management System
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Regulatory Submission, SOP, Clinical Trial
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Interoperability & Integration
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2:45 - 3:00 |
Coffee Break |
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3:00 - 5:00 |
Why eCTD and Document Management System (DMS) belong together (Liquent + NextDocs)
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DMS & eSubmission Requirements
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Document- and Dossier Lifecycles
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How NextDocs and Liquent Insight work together
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Deployment Process
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5:00 - 5:30 |
Q&A |
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Date/Time:
Thursday, 9 June 2011
1:00 - 5:30 PM GMT
Venue:
Cambridge Golf and Commerce Center
Hemingford Abbots Golf Complex - Mizuno Room
Cambridge Road
Huntingdon
PE28 9HQ
|