US FDA

Next Thursday - SBIA | Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes. Earn 1.5 hours CME | CPE | CNE

US FDA sent this email to their subscribers on February 29, 2024.

馃帴 New informational video!

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CDER SBIA Webinar Registration

CDER Small Business and Industry Assistance (SBIA)

presents

Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes


March 7, 2024

1:00 PM - 2:30 PM ET


No Fee Registration


M Small Business and Industry Assistance

馃敼 ABOUT THIS EVENT 

  • The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses.
  • This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.

馃敼 TOPICS COVERED

  • Importance of early planning
  • Types of issues to discuss at FDA Type C meeting for integrated safety
  • How to create integrated analysis sets for safety assessment
  • Appropriate analytical and statistical methods when combining clinical trial data from multiple studies

馃敼 INTENDED AUDIENCE

  • Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications.
  • More...

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Text-only version of this email

馃帴 New informational video! Receive this email as a forward? CDER SBIA Webinar Registration CDER SMALL BUSINESS AND INDUSTRY ASSISTANCE (SBIA) PRESENTS INTEGRATED SAFETY ANALYSES IN DRUG MARKETING APPLICATIONS: AVOIDING COMMON MISTAKES - March 7, 2024 1:00 PM - 2:30 PM ET - NO FEE REGISTRATION - M Small Business and Industry Assistance - 馃敼 ABOUT THIS EVENT聽 * The appropriate planning and conduct of integrated clinical trial safety analyses is critical to the success of drug marketing applications submitted to the FDA. As the safety analytics field is dynamic and evolving, continuous learning is required for the multiple disciplines (medical staff, statisticians, medical writers, etc.) that need to collaborate to create the necessary integrated tables, figures, and analyses. * This webinar will discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes. 馃敼 TOPICS COVERED * Importance of early planning * Types of issues to discuss at FDA Type C meeting for integrated safety * How to create integrated analysis sets for safety assessment * Appropriate analytical and statistical methods when combining clinical trial data from multiple studies 馃敼 INTENDED AUDIENCE * Pharmaceutical regulatory scientists, clinical reviewers, medical professionals, data scientists, statisticians, statistical programmers, medical writers working on integrated clinical trial safety analyses for new drug marketing applications. * More... 馃敼 FDA RESOURCES * FINAL FDA Guidance: Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products * More... CONTINUING EDUCATION Real-time participation is required for the certificate of attendance which can be used in support of CEs for the following professional organizations:聽RAPS,聽SOCRA, SQA, and ACRP. Certificates are聽only聽available during the two weeks post-event. For more information, see details on our聽webpage.聽聽 The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. * Register for Upcoming Training * View the SBIA 2023 YouTube Playlist * * Connect on LinkedIn * Follow on X This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at聽[email protected]聽or 1-866-405-5367 or (301) 796-6707. SUBSCRIBER SERVICES: Manage Subscriptions聽聽|聽聽聽聽|聽聽Help - This email was sent to [email protected] using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration 路聽 10903 New Hampshire Ave聽路聽Silver Spring, MD 路聽 20993-0002聽路聽聽1-888-INFO-FDA GovDelivery logo
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