PTI - international

• Meet CMC regulatory expectations to avoid FDA enforcement action
• Understand the effect of the FDA's risk-based initiative on CMC submission requirements and streamline the CMC section of your submission
• Determine specific CMC issues relevant to FDA/sponsor pre-approval meetings and enhance communication with agency reviewers
• Use drug master files efficiently and effectively and add to your arsenal of CMC communication tools
• Comply with FDA expectations for comparability protocols to help down regulate pos-approval CMC supplements and more efficiently report post-approval changes
• Streamline the CMC section of a new drug application to avoid product approval delays
• Comply with international registration requirements and implement the CTD-Quality requirements to help your firm prepare to submit regulatory applications internationally

PTi international is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmaceutical education. Participants will receive a maximum of 14 hours (1.4 CEUs) of continuing education credit for full participation in the two-day training. ACPE # 326-000-06-066-L04, Initial release: 10/2006.