PTI - international

Training Overview

• Organize and submit your application in Common Technical Document format in accordance with regulatory guidelines to speed your communication with the FDA
• Ensure proper format and content of your NDA to avoid setbacks to product approval
• Apply best practice strategies for interacting with FDA and establish a positive relationship with regulatory authorities
• Predict and address FDA concerns early on to improve chances of a timely approval
• Prepare what needs to be included in each of the CTD's five modules and follow the prescribed organization of the information required
• Plan clinical trials towards future labeling and CTD submission and prepare for a compliant future
• Submit your application via eCTD by mastering new software and tools 

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 # 326-000-04-097-L04, Initial release: 07/2004.