6 th Proactive GCP Compliance Effective Risk- Based Approaches for Optimizing Clinical Quality

Transcription

1 6 th Proactive GCP Compliance Effective Risk- Based Approaches for Optimizing Clinical Quality March 24-25, 2015 Wyndham Philadelphia Historic District, Philadelphia, PA Sponsors and Exhibitors Attendee List as of March 15 th Company AbbVie AbbVie Title Senior Director, Clinical and Pharmacovigilance QA Medical Writing QC & Contracts Manager

2 Acceleron Pharma Achillion Pharmaceuticals Inc. ADAMAS Consulting Alexion R&D QA Alexion R&D QA Alkermes, Inc. Alkermes, Inc. AstraZeneca Bayer Healthcare BIMO Auditor and Trainer, LLC BioMarin Biopharma QA and Outsourcing Consultants Biovalorem Boehringer Ingelheim Pharmaceuticals, Inc. Bristol- Myers Squibb Chugai Pharma USA, LLC ClinAudits, LLC Cook Research CryoLife Daiichi Sankyo Co., Ltd. F.Hoffmann - La Roche Ltd Genentech Gilead Sciences Director, Quality Assurance Vice President, Compliance and Quality Assurance Business Development Senior Manager, Development Quality Director, Development Quality Senior CQA Auditor Global Head CQA; GCP & GPvP Regional Clinical Process Manager Senior Global Clinical Auditor Consultant, xfda Associate Director, Development Sciences Quality Principal Managing Partner Senior Associate Director/Principal Auditor, QM- M&R, Quality Management - Medicine & Regulatory Senior Regulatory Compliance Auditor Associate Director, Quality Assurance President Quality Specialist Project Director, Clinical Research Associate Director, Development Oversight Training Manager Clinical Quality Quality Risk Specialist Associate Director, Clinical Compliance

3 Gilead Sciences Grifols Hoffmann- La Roche Limited Incyte Corporation Inovio Pharmaceuticals inventiv Health Clinical Janssen Johnson & Johnson Karyopharm Therapeutics Lexitas Pharma Services, Inc. Merck Merck Metrics Champion Consortium Pharma AG Senior Director, Regulatory Compliance R&D Compliance Audits Manager Manager, Data Acquisition Clinical Data Management Executive Director QA- GCP Director, Clinical Compliance Senior Vice President, Operational Quality Management Associate Director, Global R&D Quality & Compliance Quality Monitoring & Compliance Manager GCP Quality Manager Manager, Clinical Operations and Quality Assurance Associate Director Compliance Director, Clinical Quality and Process Management Co- Founder & President Project Management Liaison, Translational Clinical Oncology Process Control Manager Director, QA Compliance, Inspection & Risk Management Global Program Quality Lead, Pharma Development Clinical Quality Assurance Clinical Quality Expert, Oncology Development QA Process Control Manager Senior Compliance Specialist, Development QA Standards Global Head, Clinical Development Quality Assurance Global Head Pharma Dev. Franchise QA Immunology, Dermatology & Neuroscience

4 Novo Nordisk A/S Novo Nordisk A/S Otsuka Pharmaceutical Development & Commercialization, Inc. PEARL Network Pfizer Premier Research Purdue Pharma L.P. QD- Quality and Training Solutions, Inc. Sanofi Sarah Cannon Research Institute Sarah Cannon Research Institute Shire Sparta Systems Sparta Systems TESARO, Inc. Teva Senior GCP Advisor Senior GCP Advisor Associate Director, Clinical Quality Management Senior Clinical Research Associate Associate Director, Portfolio Quality & Risk Management Principal QA Auditor Director, Contracted Consulting Services QA Auditor Vice President, Global Quality Assurance Director, R&D Quality Assurance: GLP/GCP/Support President & CEO Senior Director, Knowledge Management GxP Global Auditor Manager, Clinical Quality Assurance Senior Director, Global Quality and Education Head of Clinical QA & Compliance Programs, R&D Quality Assurance & Compliance Director, Solutions Consulting Business Development Manager, Clinical Operations Global Clinical QA Auditor

5 TransTech Pharma LLC Trevena, Inc. Triligent International Vertex Pharmaceuticals, Inc. VirtualScopics, Inc. VirtualScopics, Inc. World Courier Zigzag Associates Ltd. Director, Quality Assurance Vice President, Clinical Operations CEO Director, PV Quality Compliance Management Quality Specialist Manager, QA & Validation Director, Business Development Managing Director, Global Client Services