The Center for Professional Innovation & Education (CfPIE), Costa Mesa, CA
Feb. 26 & 27, 2007
Who Should AttendDesigned for all employees involved in the preparation and review of market application submissions (New Drug Applications, Abbreviated New Drug Applications, Biologic License Applications and Market Authorization Applications). This includes Regulatory Affairs staff, employees responsible for assembling, collating and presenting documentation, managers and members of other Departments responsible for generating and approving such documentation, including personnel involved in: • Regulatory Affairs
• Clinical and Medical Affairs
• Medical Writers
• IT personnel involved in eCTD development
• Product Development
• Manufacturing
• Quality Control
• Quality Assurance Learning Objectives Learn how to navigate through the extensive guidance provided – both ICH harmonized and regional (FDA and EMEA) – for assembling regulatory compliant dossiers in the CTD format. This course is designed to identify and review all regulations and guidelines involved in the preparation of the CTD. Attendees will understand the rules regarding formatting and organization of the documents into the 5 CTD Modules. Attendees also will understand the eCTD guidelines and systems. Course Description While the birth of ICH took place in 1990, it was not until 2000 that the 3 major regulatory agencies (FDA, EMEA, JMHWL) signed off on the Common Technical Document (CTD) format. ICH M4 was thus introduced to the pharmaceutical industry, followed by specific guidances on how to prepare the Quality, Safety and Efficacy sections in the CTD format. Today, the CTD format is mandatory in European and Japanese submissions, expected in Canadian submissions, and highly recommended in FDA submissions. In 2003, the electronic (e) CTD (ICH M2) was introduced to the pharmaceutical industry. Substantial documentation and data are required in market application submissions, resulting in large, complex applications. It is not a simple matter to compile the information or to review it. Applicants have used many different approaches to organizing the information, but differences in organization of each application make regulatory agency review more difficult and may lead to omission of critical data or analysis. Such omissions can result in a decision by the regulatory agency to refuse to file an application. This course will set companies on the correct path to compliance.
________________________________________ COURSE AGENDA DAY ONE Introduction to ICH and the CTD • How did ICH and the CTD get here?
• Five (5) major misconceptions about the CTD
• CTD: Its all about format! Module 1 – Regional Administrative • Why Module 1 is ‘not part of the CTD’
• Completely regional driven
• Similarities/differences between the FDA and EMEA versions of Module 1 Module 2 – Summaries • The five (5) required summaries/overviews (Quality - 1, Nonclinical - 2, Clinical - 2)
• Harmonized but regionally impacted!
• Critical relationship to Modules 3, 4 and 5 Module 3 – Quality • It’s all about the ‘S’s and ‘P’s
• Handling drug master files and outsourcing vendors
• Strategies for facilitating the QOS (Module 2.3)
DAY TWO
Module 3 – Quality (continuation from Day 1) Module 4 – Nonclinical Study Reports • Facilitating the preparation of Modules 2.4 and 2.6
• Importance of Good Laboratory Practice (GLP) to the CTD
• What if an animal study is not required for your drug Module 5 – Clinical Study Reports • Facilitating the preparation of Modules 2.5 and 2.7
• Primary objective for clinical study reports
• Handling multiple human efficacy indications eCTD Specification
• More than just providing an electronic submission of the CTD
• Evolving eCTD specification
• Critical need to interface with regulatory agencies
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