Contents Foreword David M Vulcano
Assistant Vice President and Responsible Executive, Clinical Research, Hospital Corporation of America, Nashville
Drug Safety
Clinical Trial Safety – The Goldilocks Dilemma – Balancing Effective and Efficient Safety Monitoring
Jonathan Seltzer
President, Applied Clinical Intelligence, and Director, Clinical Research, Main Line Health Heart Center
Pharmacovigilance in the ‘New Pharma’ Ron Fitzmartin1
and John Wise2
1. Managing Partner, Decision Analytics, LLC, Woodbridge, Connecticut; 2. Executive Director, Pistoia Alliance, Milton Keynes
Regulation and Risk
The ‘New Normal’ of Regulatory Oversight of Clinical Investigators David M Vulcano
Assistant Vice President and Responsible Executive, Clinical Research, Hospital Corporation of America, Nashville
The Efficacy of Patient and Healthcare Provider Communication Tools as Risk Mitigation Strategies
Sally Van Doren President and Chief Executive Officer, BioSoteria Inc.
A Prescription for Industry – Risk Evaluation and Mitigation Strategy and Safety as a Paradigm
Axel K Olsen1 and Matthew D Whalen2 1. Executive Director, LifeCycle Safety, Quintiles; 2. Principal, Impact LLC Research and Development Strategies
Non-clinical Assessment of New Drug Products Michael R Hamrell
MORIAH Consultants, Yorba Linda
Botanical Drug Development – How Natural Health Products Can Become Drugs
Jay Udani
Chief Executive Officer and Medical Director, Medicus Research, and Medical Director, Northridge Hospital Integrative Medicine Program, and Assistant Clinical Professor, UCLA School of Medicine
The Benefits and Risks of Using Positron Emission Tomography in Clinical Drug Development
Julian C Matthews Senior Lecturer, Wolfson Molecular Imaging Centre, University of Manchester Clinical Trial Management
Data Management Systems versus Data Warehousing – What Really Matters
Norbert Fritz1 and Charlotte Mauron2
1. Development Leader, Business Intelligence Warehouse, Product Development, F Hoffmann-La Roche Ltd, Basel; 2. Manager, Data Modelling and Acquisition, Biometrics, F Hoffmann-La Roche Ltd, Basel
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DRUG DEVELOPMENT
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