International Regulatory Cooperation Among Agencies 2015

Topics

• What can be shared and what is confidential
• View of Regulatory Agencies to sharing data
• What are cluster meetings and when are they occurring
• Current status of meetings of Regulatory Agencies
• How countries are working together to improve the efficiency of review of generic submissions
• What are Tier 1, Tier 2, their 3 and other regulatory agencies
• Could the European paradigm be expanded further
• Using international reviews to gain approval
• How ICH and CIOMS impact international harmonization
• How Pharmacovigilance impacts international harmonization
• Inspections and GMP approached internationally

Who should Attend

• Manager of Regulatory Affairs
• Director of Regulatory Affairs
• Manager of QA
• Director of QA
• CEOs
• Director of Marketing
• Director of PV
• Safety Director