A medical device company making a submission to the FDA on any of these: INDs, NDAs, BLAs, ANDAs, PMAs, 510(k)s, IDEs, and Post-Approval Supplements; needs practice and learning of all the intricate aspects of these activities. The FDA approval is necessary to start legal manufacturing a medical device or a combination product in the US. The FDA drug and device approval system is complex, and this understanding needs to be there on the part of the submitting company.
Of equal importance as the submission is how to communicate with the FDA about these at various stages before, during and after the submission. It calls for a thorough understanding of the regulations in all their detail. This complete understanding is necessary to sail through the filing process. Companies making the filing need to have an effective submission strategy, failing which they could invite enforcement actions from the FDA, not to speak of the waste of resources and time.
Complete learning all the aspects of FDA submission for medical devices and combination products
A two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering complete and clear understanding of these aspects of an FDA submission. David Dills, Global Regulatory Affairs & Compliance Consultant and President, NovaQual, will be the Director at this seminar.
David provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
Understanding the regulatory requirements
David will explain all the details that need to go into an FDA submission to meet the regulatory requirements. FDA 510(k) submissions for obtaining FDA clearance, FDA Investigational Device Exemption (IDE) submissions for US clinical studies, FDA Requests for Classification and Requests for Determination, FDA Pre-Submission (Pre-sub) meetings, the PMA and its various submissions such as e.g. traditional, modular, streamlined, etc., the advantages and disadvantages of each, the Summary of Safety and Effectiveness Data (SSED) and the way in which to use it, determining when an IDE is required, and IDE, PMA and 510(k) submission management activities are some of these.
This detailed session on FDA submissions and communicating with the FDA is of value to personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post approval supplements). David has tailored the course content to suit the needs of those who interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel.
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