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Webinar On FDA Approval Process for Combination Products

This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

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Webinar On FDA Approval Process for Combination Products

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  1. ContactUs:416-915-4458 WeEmpower,YouComply! Webinar On FDA Approval Process for Combination Products ProductId FDB1224 Food, Drugs & Biologics Category Friday, June 20, 2014 at 13:00 Hrs Scheduled On Duration 120 Minutes Speaker Albert A. Ghignone Toregisterforthiswebinarvisit https://compliancetrainings.com/siteengine/Login.aspx Webinar Description: This 2 hours webinar will provide a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved. A must attend webinar for those who have Combination Products or are anticipating that they will be developing Combination Products. This webinar explains the entire FDA Combination Product Process and how to navigate the FDA Combination Product system. This webinar provides a comprehensive understanding of the FDA Combination Product Process including the FDA Office of Combination Products, mode of action, primary mode of action and how to prepare a Request for Designation submission. If your concern is to get your Combination Product on the USA marketplace this webinar is a must attend for you. Areas Covered in the Session: • FDA Office of Combination Products • FDA Combination Product Process • How to navigate the FDA Combination Product system • Mode of Action and Primary mode of action • How to prepare a request for designation submission • How to interact with the FDA Office of Combination products • Q&A Session

  2. Who will benefit: • Regulatory Affairs Personnel • Quality Personnel • Clinical Personnel • Research Personnel • Manufacturing Personnel • Legal Personnel • Auditors • Clinical Research Associates • Personnel who require a general understanding of the USA Combination Product Process. SpeakerProfile: Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. He has been responsible for regulatory submissions, registrations, FDA liaison, clinical studies, compliance activities and FDA training. He also has expertise in the assessment of product and facilities for due diligence relative to FDA requirements. Toregistervisithttps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=FDB1224

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