DIA Webinar: Worldwide Regulatory Landscape: Current Regulatory Initiatives in the US, Canada and EU

DIA - Drug Information Association, Online Webinar
July 15, 2009

Overview India has been one of the major global players in the development of generic drugs, continues togain visibility in the development of new drugs, and is one of the major geographies for conducting multinational clinical trials. Learn how intergovernmental initiatives and partnerships between India’s Drug Regulatory Department (DCGI office) and USFDA, Health Canada, MHRA and EMEA would add to India’s role in the development of new medicines.

Learning Objectives At the conclusion of this webinar, participants should be able to:

• Identify initiatives taken by FDA, EMEA, MHRA and Health Canada with DCGI office
• Recognize what potential impact these initiatives may have in the advancement of clinical research
• Discuss potential future initiatives

• Academia
• Biostatistics
• Clinical research and development
• Clinical safety and pharmacovigilance
• Clinical supply operations
• Clinical trial and project management
• Data management
• Drug development and discovery
• Investigator site management
• Medical and scientific affairs
• Outsourcing management/contract research organizations (CROs)
• Pre-clinical development
• Post-graduate studies
• Procurement and purchasing
• Quality assurance
• Research and development
• Strategic sourcing/planning
• Regulatory affairs
• Government and public policy
• Senior- and executive-level decision makers for clinical trials

Satish C. Tripathi, PhD, MPharm, MS, RAC
President and CEO
Biomedical Consulting International, Inc., United States

Albinus M D'Sa
Compliance Officer
FDA/CDER, United States

Gopalan Narayanan, MD
Head, Biologicals and Biotechnology Unit
MHRA, United Kingdom

Supriya Sharma, MD, MPH, FRCPC
Director General, Health Products and Food Branch
Health Canada, Canada