A description of the various stages and sections of a Master Regulatory File (MRF) System. As an investigational product progresses through development key studies, decisions, regulatory communications, manufacturing progression are accumulated and necessary to reference as the NDA and MAA applications are made. Therefore MRF systems needs to preplanned and have sections to organize this information. Although this won’t be discussed this organization is applicable to a well managed document management system.
Objectives of the Presentation:
The objective of the presentation is to provide an organizational system for Regulatory Master Files to be used to build a NDA or MAA application
Areas Covered:
- Regulator communications and meetings
- eCTD structure
- CMC and Drug Master Files
- Trial Master Files
- Clinical Programs
- Target Product Profiles (TPP) and mock Package Inserts
Who will benefit:
- Regulatory Affairs Personel
- Regulatory Consultants
- CMC
- Clinical and Regulatory Coordinators
Why you should attend:
There are already described several different types of master files like the Trial Master Files and the Drug Master File. These master files are well defined file systems set up to organize information as new information comes in and to provide the detailed core information needed to make decisions. A Master Regulatory Folder is designed to build the NDA from the when an investigational product is only a candidate and to have the information necessary readily at hand to retrieve. As with a Trial Master File, the Master Regulatory Files are the collection of the key documents, regulatory communications and other materials to be able to recreate the progression of the development of the product into a central organized system.
Instructor Profile
John (Jack) McLane is COO and VP of Clinical and Regulatory Affairs at Clinquest. Skilled at leading full regulatory and clinical development projects resulting in successful INDs, IDEs, NDAs, MAAs and developing regulatory and clinical processes and strategies. Extensive experience leading global management teams by providing strategic assessment, management and program metrics to develop innovative drugs. An innovative leader, experienced in start-ups, venture capital funded, and global clinical research (CRO) firms encompassing all Phases and types of products in the pharmaceutical, biological and medical device industries. Known for formulating and executing strategies that align mission, operations, products and goals for competitive advantage, improved ROI and generating quality results.
Live Session for one participant
Price: $225.00
Corporate Live Session 4 to 10 participants in single location.
Price:$885.00
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $275.00