DIA eBooks
Achieving Excellence in Regulatory Information Management
The original RIM white paper was released in October 2019. Since then, members of the DIA Regulatory Affairs Community, working in Regulatory Information Management (RIM), have continued to update this paper as the field has evolved. The original version focused on several key topics relating to core RIM capabilities. White paper 2.0 kept pace with industry thinking, expanding to new topics such as regulatory intelligence and automation.
Over the last several years, the white paper team has increased breadth and depth to bring you a complete 3.0 publication in the form of best practices across the spectrum of RIM capabilities and functional interfaces.
eBook Price: $35.00
Purpose of the Publication
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Bring current leading practice in regulatory operations to both seasoned and new regulatory professionals
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Encourage adoption of new practices and technologies to improve the way regulatory works
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Help companies bring medicines to patients in a more efficient manner
Sample Hot Topics Included in eBook
Drug / device combinations
Helping regulatory drug teams understand the expectations of the Center for Devices and Radiological Health, MDR and other device topics
Intelligent Automation
Exploring use cases, in development and in use - to enhance regulatory performance
Functional Intersections
Exploring the important connections across the enterprise to streamline process, accelerate submissions and improve compliance
RIM Reference Model
Introduction to RIM Reference Model with entities, relationships, and the data attributes
Authors
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Venkatraman Balasubramanan (Bala), PhD, MBA
Orion Innovation
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Segolene Balling, MBA
Merck & Co., Inc.
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Vanessa Brewar-Yizar
Gan & Lee Pharmaceuticals
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Kathie Clark, MA
Kathie Clark Expert Services for Life Sciences
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Meghan Cox
KPMG LLP
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Joel Finkle
Retired Regulatory IT Expert
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Steve Gens, MSOD
Gens & Associates
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Vahe Ghahraman, PhD, MS
Apellis Pharmaceuticals, Inc,
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Shakul Hameed, MBA, MS
Sanofi
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John Jones, MBA
Entitech Solutions
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Renata Kover
Cencora, Inc.
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Gerald Kukko
Johnson & Johnson
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Dominique Lagrave, PharmD
Accumulus Synergy, Inc.
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Karl-Heinz Loebel
PharmaLex
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Sheila Mahoney-Jewels, MBA
LifeSciHub
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Tris Nockles
Navitas Life Sciences, Inc.
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Donald Palmer, MA
Numbers Unlimited, Ltd.
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Keith Parent
Court Square Group
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Nirjhar Sarkar, MS
Independent Consultant
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Karin Schneider, MS
Janssen Research & Development
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Patterson Shafer
FTI Consulting
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Cary Smithson, MBA
LeapAhead Solutions, Inc.
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Cheryl Tan, MS
FTI Consulting
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Brian Williams
KPMG LLP
DIA would like to thank its sponsors of this publication:
Gold
FTI Consulting
Orion Innovation
Bronze
KPMG LLP
Patterson Shafer
PharmaLex