Events

Events

• March 19, 2018: Public workshop - Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data (Silver Spring, MD and webcast) - register by March 12, 2018 - Also see Plan for Issuance of Patient-Focused Drug Development Guidance (PDF, 146 KB)
• March 19, 2018: Public workshop - Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Settings (Silver Spring, MD and webcast) Advance registration required. To view the webcast, register before 5:00 p.m. ET March 18, 2018.
• March 20, 2018: Promoting the Use of Complex Innovative Designs (CID) in Clinical Trials public meeting (Silver Spring, MD and webcast) - to (1) facilitate discussion and information sharing about the use of CID in drug development and regulatory decision making and (2) obtain input from stakeholders about the CID pilot program.
• New! March 20-21, 2018: Engaging the Private Sector Health Care System in Building Capacity to Respond to Threats to the Public’s Health and National Security (Washington, DC), hosted by the National Academies of Sciences, Engineering & Medicine (NASEM) - Through this workshop, the committee will bring together public and private sector partners to discuss approaches to aligning healthcare system incentives with the American public’s need for a healthcare system that is optimally prepared and scalable to manage acutely ill and injured patients during a disaster, public health emergency, or other mass casualty event.
  
• New! March 21-22, 2018: Joint Meeting of the Blood Products Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee (Silver Spring, MD and webcast) - agenda includes an overview of research programs of the Laboratory of Emerging Pathogens, the Laboratory of Bacterial and Transmissible Spongiform Encephalopathy Agents, and the Laboratory of Molecular Virology in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, FDA Center for Biologics Evaluation and Research (CBER)
• New! March 22, 2018: Public Workshop of the Committee on the Use of Elastomeric Respirators in Health Care (Washington, DC), hosted by NASEM - Topics include challenges and opportunities for the use of elastomeric respirators in public health preparedness and emergency response - Related FDA research: Optimizing Respirator Decontamination to Ensure Supplies for Emergency Preparedness
• March 22, 2018: Patient Engagement in the National Evaluation System for Health Technology (NEST): Lessons Learned and Best Practices (Baltimore, MD), hosted by the University of Maryland and FDA - The workshop will gather lessons learned and best practices for patient engagement in evidence generation (e.g., planning, collection of data and information, analysis, and dissemination).
• New! April 6, 2018: FDA and Health Canada Joint Regional Consultation on the ICH public meeting(Silver Spring, MD and webcast) - register by April 3, 2018 - this meeting is to provide information and receive comments on the current activities of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as well as the upcoming meetings in Kobe, Japan scheduled for June 4-7, 2018 
• New! April 10, 2018: Webinar for healthcare professionals - An Introduction to Drug Safety Surveillance and the FDA Adverse Event Reporting System, 1:00 p.m. ET - advance registration required
• April 16, 2018: Evaluating Inclusion and Exclusion Criteria in Clinical Trials (Washington, DC and webcast) - register by April 12, 2018 
• April 17-20, 2018: Preparedness Summit (Atlanta, GA) - The theme for the conference is Strengthening National Health Security: Mastering Ordinary Responses, Building Resilience for Extraordinary Events.  (fee)