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PANEL DISCUSSSION - INTERNAL QUALITY EDUCATION
Strategies for Educating, Training and Developing a Capable Organization
Moderator:
Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS, INC., Member, Board of Trustees, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS (ACRP)
Panelists:
- Louise Ebbert, Manager, Clinical Quality Assurance, LUNG LLC
- David W. Fryrear, Advisor, Quality System Integration, ELI LILLY AND COMPANY
- Sharon Reinhard, Associate Director, Clinical Quality Control, ENDO PHARMACEUTICALS
PANEL DISCUSSION – MEASURING QUALITY
Strategies for Assessing GCP Compliance and Identifying Areas for Improvement
Moderator:
Maryann Livolsi, MSN, RN, Director, R&D Compliance & Process, SHIRE
Panelists:
- Anne Adams, Associate Vice President, Clinical Trials Audits & Compliance, EMORY UNIVERSITY
- Maggie Ayers, Senior Director, Clinical Trial Management, ICON CLINICAL RESEARCH
- Simona Cipra, Managing Director, HALLORAN CONSULTING GROUP, INC.
- Val Milkhailovski, Associate Director, Global Clinical Quality & Compliance, NOVARTIS VACCINES & DIAGNOSTICS
PANEL DISCUSSION – INSPECTION READINESS
Best Practices for Achieving GCP Inspection Readiness on a Global Scale
Moderator:
John Wilson, Jr., PhD, MPH, Senior Vice President, BEAUFORT LLC
Panelists:
- Katie Alberta, Senior Director, Worldwide QA, Good Clinical and Pharmacovigilance Practices, TEVA PHARMACEUTICALS
- Cherif Benattia, MD, Head of Medical Surveillance & Risk Management, SUNOVION PHARMACEUTICALS
- Linda Delpaggio, Associate Director, Clinical Quality Assurance, MILLENNIUM PHARMACEUTICALS
- Germaine McGinnis, MS, Associate Director, Clinical Quality Assurance, ICON CLINICAL RESEARCH
PANEL DISCUSSION – GUIDANCE INTERPRETATION
What do the FDA and EMA Guidances REALLY Mean for the Industry?
Moderator:
Joanne Spallone, Global Head, Franchise QA, Primary Care & Translational Medicine, NOVARTIS
Panelists:
- Arti Bajpai, Senior Director, R&D Compliance, SHIRE
- Deirdre BeVard, Vice President, Development Operations, ENDO PHARMACEUTICALS
- Valerie Palumbo, Senior Vice President, Corporate Quality, PHARMANET/i3
- Paul Strickland, Director, Inspections & Intelligence, Global R&D Compliance, AMGEN UK, Chair, Audit Working Party, EUROPEAN FORUM FOR GOOD CLINICAL PRACTICE (EFGCP)
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Just Added to the Program!
GCP RISK MANAGEMENT TECHNOLOGIES
Lessons Learned from Japanese Clinical Trials and Feasibility for US IND Clinical Studies
Lawrence W. Yarmaloff, CCRA, Founder and Principal Consultant, PANACEA CLINICAL RESEARCH consulting for FUJITSU
- What is a “GCP risk management tool” and how does it work?
- Case Study: Benefits of a GCP risk management tool for industry standard quality processes in Japanese clinical trials
- Quality and regulatory compliance challenges of clinical trials in US and Japan; similarities and differences
- Applying a GCP risk management tool solution to US IND clinical studies
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