This program will address current challenges in global safety-related compliance, with each day culminating in interactive panel sessions exploring whether harmonization efforts have indeed
fostered compliance.

During these two days, attendees will:
• Learn from regulators, industry personnel and consultants encompassing ICH and select non- ICH sectors.
• Explore premarketing (GCP; clinical safety) and postmarketing (pharmaceutical; medical device) regulatory requirements.
• Discuss safety-related US, EU, and Japan inspectional programs.
• Learn about the EU EudraVigilance and EUDRACT systems.
• Understand legal implications of premarketing trials and postmarketing safety operations.
• Review “lessons learned” regarding quality local and global company standard operating procedures(SOPs).
• Understand Global Harmonization Task Force (GHTF) medical device initiatives.
• Review special issues in clinical trials:
- Integrated Safety Summary and statistical/data analysis considerations.
- Institutional Review Boards (IRBs), Data Safety Monitoring Boards (DSMBs), and human subject protection.
- MedDRA® usage in clinical trials and premarketing safety.