"Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development" ed. by Steve Olson, Anne B. Claiborne

2012 | ISBN: 0309222141 9780309222143 | 103 pages | PDF | 2 MB

The IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce.
FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency.

Contents
ACRONYMS
1 INTRODUCTION
Scope of the Workshop and Organization of the Summary
2 THE IMPORTANCE OF INNOVATIVE REGULATORY SCIENCE
Perspective from the Food and Drug Administration
Perspective from the National Institutes of Health
Perspective from the Pharmaceutical Industry
Perspective from Academia
Patient Perspective
Principles and Themes
3 DEFINING A DISCIPLINE OF REGULATORY SCIENCE AND CORE COMPETENCIES FOR ITS WORKFORCE
Defining Regulatory Science Through the Lens of Translational Science
Defining Regulatory Science as Science of Evaluation of Regulations
Case Studies: Regulatory Science in Practice
Core Competencies of Regulatory Science
Defining Regulatory Science
4 EDUCATION AND TRAINING OF A REGULATORY SCIENCE WORKFORCE
An Overview of Existing Training Programs
Developing Education and Training Programs in Regulatory Science
Models for Education and Training
Fellowships and Exchange Programs
5 CAREER PATHS WITHIN ACADEMIA AND INDUSTRY
Career Paths in Academia
Career Paths in Industry
6 INTERNATIONAL APPLICATIONS OF REGULATORY SCIENCE
Maintaining a Robust Global Therapeutics Pipeline
Therapeutics Development for Global Neglected Diseases
7 COLLABORATIVE MODELS AND NEW PARADIGMS FOR SUPPORTING REGULATORY SCIENCE RESEARCH AND PRACTICE
Creating a Collaborative Environment in an Academic Setting
A Collaborative Model for Research, Training, and Business Development
Regulatory Science: Solving for a Larger Context
Closing Panel
REFERENCES
APPENDIXES
A WORKSHOP AGENDA
B PARTICIPANT BIOGRAPHIES

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