Date: 8th Oct 2013
Venue: The Palace at Somerset Park, New Jersey
Join top industry experts from a variety of disciplines for an intimate discussion workshop of the challenges and trends facing today's global clinical trials.
This workshop will focus on giving the attendee a comprehensive overview of the challenges and obstacles present in emerging and underserved markets across the globe. Additionally, it will provide the attendee with an excellent grasp of the breadth of solutions that the clinical supply industry offers to overcome these challenges
Attendees will also learn more about recent industry innovations launched by Catalent including our new facility in China, the Catalent "Center of Excellence" model, our industry leading clinical management solutions, and our rapidly growing regulatory consulting group.
Lunch and refreshments will be provided at breaks.
Key Learning Objectives:
- Understand the main regulatory authorities in Brazil, China and Japan, how are they structured, and their requirements and review procedures for new drug applications.
- Understand the role of clinical Supply Management in today's changing outsourcing environment
- Explore systems and processes that can support the real time management of clinical studies
- Introduction to Optimizer Supply Forecasting Tool (Brief overview and demonstration)
- Case studies where Simulation in addition to traditional supply chain management has brought benefit and savings to clinical trials
Who Should Attend:
- VP/Director/ Head of Research & Development
- VP/Director/ Head of Regulatory Affairs
- VP/Director/ Head/Director/Manager of Operations (Manufacturing)
- VP/Head/Director/Manager of Clinical Development
- Chief Scientific Officer
- Clinical Supply Project Management
- Clinical Development Project Management
- Clinical Trial Supply Managers
- Clinical Logistics/Distribution Management Personnel
- Clinical Research Organizations
Victoria Dunay, Manager, Clinical Supply Chain Optimization, BioClinica Global Clinical Trial Solutions.
As Manager of the Clinical Supply Chain Optimization group at BioClinica, Victoria Dunay is responsible for overseeing the support team for Optimizer and EDA. She has over 8 years of experience in IVR/IWR, clinical packaging, global distribution/logistics, and supply chain management.
Esther Sadler-Williams, Global Director, Strategic Development and Innovation
As a pharmacist, Esther has had over 30 years experience in various pharmaceutical fields including 5 years with Sanofi Winthrop where she was Head of Research Services during which time she managed groups of CRA.'s medical writers and information/adverse event surveillance specialists.