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FDA CDER Prescription Drug Labeling Conference 2017

FDA’s Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA) Regulatory Education for Industry (REdI) invites you to attend our two-day labeling conference in person or virtually.

The goal of this interactive conference is to provide helpful information pertinent to prescription drug labeling development. Both FDA and industry labeling specialists will present their unique perspectives concerning approaches and challenges in developing the prescribing information, patient labeling, and Structured Product Labeling (SPL). Meeting participants will have an opportunity to share their experiences and ask questions during the question and answer panels.

Attend virtually via Adobe Connect or participate in person at the Tommy Douglas Conference Center in Silver Spring, Maryland.

Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update

Wednesday, November 08, 2017, 2:00pm – 3:30pm (Eastern)

Join us as our FDA experts provide  an overview of recent updates made to FDA’s Study Data Technical Conformance Guide.  This Study Data Technical Conformance Guide (TCG) provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the  FDA Data Standards Catalog.   The TCG supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Standardized Study Data and provides technical recommendations to sponsors for the submission of animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs.

Adobe Digital Government Technology Conference

The 2017 Adobe Digital Government Technology Conference will feature sessions built towards enhancing the public sector’s understanding of Adobe solutions towards agency projects and missions, providing thoughtful and hands-on sessions for end-users.  This event is 8:00am – 3:00pm at the Washington Marriott Marquis, 901 Massachusetts Ave NW, Washington, DC 20001.

Attend to learn how Adobe is transforming how agencies securely create, manage, deliver, and optimize personalized digital exeperiences across platforms.

The day will consist of:

  • Keynote addresses from roadmap makers in Adobe Public Sector
  • In-depth user sessions on Adobe solutions and how they apply to your workflow and mission
  • All-day interactive pavilion for optimal networking with peers and industry
  • Product technology lounge for one-on-one technology discussions