The Center for Professional Innovation & Education, Malvern, PA
June 4 & 5, 2007
Who Should Attend
This course is designed for personnel in the pharmaceutical and biotechnology industries involved in the preparation and review of marketing applications for submission to regulatory agencies. These personnel include regulatory affairs staff, medical and scientific writers, personnel responsible for assembling and collating documentation, managers and supervisors of departments responsible for generating and approving these documents. These departments include, but are not limited to:
Chemistry, Manufacturing, and Control Department
Nonclinical Pharmacology, Pharmacokinetic, and Toxicology Departments
Clinical and Medical Research
Quality Control and Quality Assurance
IT and other personnel involved in eCTD development
pon completing this course, participants will have an understanding of how to employ the extensive recommended guidances – both ICH and regional (FDA and EMEA) – for preparing and assembling a marketing application in the recommended CTD format. This course is designed to identify and review those guidelines providing information on the preparation of the CTD. Attendees will gain an understanding of the formatting and organization recommendations for the documents to be included in the 5 CTD modules. Attendees will also gain an understanding of the recommendation in eCTD guideline.
UThe ICH process was initiated in 1990 and in 2000, the 3 major regulatory agencies (FDA, EMEA, JMHWL) involved in the ICH process signed off on the Common Technical Document (CTD) guideline. ICH M4 was thus introduced to the pharmaceutical and biotechnology industry along with specific guidances on the preparation of the Quality (M4Q), Safety (M4S), and Efficacy (M4E) sections in CTD format. Today the CTD format is mandatory in European and Japanese marketing application submissions, is expected in Canadian submissions, and is highly recommended in FDA submissions. In 2003, the electronic (e) CTD (ICH M2) was introduced to the pharmaceutical and biotechnology industry.
Substantial documentation and research results need to be summarized for inclusion in a marketing application and all the technical reports and other documentation prepared on these research results need to be included, resulting in a large, complex application. Compiling and then reviewing this large amount of information is not a simple or easy matter. Previously, applicants used many different approaches for organizing this information but these differences made regulatory agency review more difficult and frequently led to the omission of critical data and/or analysis. Such omissions frequently resulted in a regulatory agency refusing to file an application or in requesting that the missing information be generated and providing, resulting in a delay, sometimes substantial, in approval. The course on the CTD will provide applicants with the information needed to prepare a marketing application submission that is in compliance with regulatory agency recommendations.