Registration Open: Regulatory Education for Industry (REdI) - Boston, MA - May 29-30, 2019

Registration Open Regulatory Education for Industry (REdI) Annual Conference

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Date and Time May 29-30, 2019 | Wednesday and Thursday Location  The Revere Hotel | Boston, MA or Online You may attend in-person or virtually. This event is FREE.

Agenda

Keynote Speaker - Drug Track Doug Throckmorton, MD | Deputy Director for Regulatory Affairs | CDER | FDA About this Event CDER and CDRH invite you to interact with and learn directly from FDA’s regulatory experts. This course is designed to provide participants with a strong, basic foundation in understanding the FDA’s drug and medical device regulatory requirements. Attendees will leave with a set of tools to assist in preparing regulatory filings and interacting with the FDA. FDA speakers will be available to answer questions one-on-one at the end of each day. Drugs track: Will focus on the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs). Devices track: Will address globalization, harmonization, and standardization of medical device regulation. Topics Plenary Session: Navigating the World of Combination Products A Medical Officer’s Approach to NDA/BLA Review Regulatory Highlights for Biosimilars and Interchangeables Quality System Regulation and ISO 13485 Comparison: Corrective and Preventive Action (CAPA) Requirements Building Quality Clinical Data into Premarket Approval Applications (PMAs)

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Intended Audience Those interested in the essentials of New Drug Applications (NDAs) and Biologics License Applications (BLAs) submissions and globalization, harmonization, and standardization of medical device regulation. Newcomers, managers, or directors in the drug or medical device industries Regulatory affairs Research and development Quality assurance and control Development and preparation of submissions