The Drug Development Process - From R&D to Commercialization - Webinar By GlobalCompliancePanel 2012

Topics

• The purpose of Pre-clinical studies
• The transition from discovery to development
• Milestones on The "Dual Path" to Drug Commercialization
• The four major clinical phases (1-4) in the drug development process and the rationale for each with key deliverables
• Overview of the key government regulations that impact the development process (Code of Federal Regulations and ICH)
• Where do IND and NDA fit into the process
• The criticality of effective project management for cross-functional teams during the development process with special focus on managing activities performed by contract manufactures, labs and suppliers
• Designing the drug with the patient and regulations in mind

Who should Attend

• Clinical monitors and research associates
• Research & development scientists
• Statisticians & data management professionals
• Medical and clinical investigators and study coordinators
• Regulatory Affairs Professionals
• CMC/pharmaceutical research professionals
• Senior sales managers
• Project Managers
• Program Management
• Analytical Development