Tag: Development

Workshop on regulatory support for development of orphan medicines

On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of early regulatory interactions and incentives for the development of medicines for rare diseases.

The purpose of the workshop is to encourage early dialogue between developers and regulators in order to facilitate the development of innovative medicines in neglected disease areas. The workshop is targeted at small and medium-sized enterprises (SMEs), academia, patients, healthcare professionals and European Reference Networks (ERNs) who are often at the forefront of medicine development in rare and neglected diseases.

There are over 6,000 rare diseases that affect about 30 million

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FDA-NRC Workshop Enhancing Development of Novel Technologies: Radiopharmaceuticals and Radiological Devices – 10/14/2020 – 10/14/2020


 

Topics for Discussion

  • Overview of Regulatory Process for Marketing and Licensing of Radiopharmaceutical Devices
  • Novel Radiopharmaceuticals: physical standards development, product quality considerations, supply and demand
  • Safety and Efficacy Considerations for Radiopharmaceutical Products
  • The Evolving Landscape—Radiological Devices
  • Clinical Trial Design Considerations for Radiopharmaceuticals

Questions be submitted to Lisa Dimmick at [email protected]

WebEx Registration

The October 14th workshop will be conducted using Cisco WebEx.  To participate in the workshop, please pre-register by October 9, 2020 at https://usnrc.webex.com/usnrc/onstage/g.php?MTID=eabeba69a55ff5fc6faf8d90db0b2e450.

To test your ability to connect to a WebEx meeting, visit https://www.webex.com/test-meeting.html.  Please contact your IT department if the test fails.  For

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FDA-NRC Workshop Enhancing Development of Emerging Technologies: Radiopharmaceuticals and Radiological Devices – 10/14/2020 – 10/14/2020


 

Topics for Discussion

  • Overview of Regulatory Process for Marketing and Licensing of Radiopharmaceutical Devices
  • Novel Radiopharmaceuticals: physical standards development, product quality considerations, supply and demand
  • Safety and Efficacy Considerations for Radiopharmaceutical Products
  • The Evolving Landscape—Radiological Devices
  • Clinical Trial Design Considerations for Radiopharmaceuticals

Questions be submitted to Lisa Dimmick at [email protected]

WebEx Registration

The October 14th workshop will be conducted using Cisco WebEx.  To participate in the workshop, please pre-register by October 9, 2020 at https://usnrc.webex.com/usnrc/onstage/g.php?MTID=eabeba69a55ff5fc6faf8d90db0b2e450.

To test your ability to connect to a WebEx meeting, visit https://www.webex.com/test-meeting.html.  Please contact your IT department if the test fails.  For

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Topical Drug Development Workshop – Evolution of Science and Regulatory Policy 2 – 07/23/2020 – 07/24/2020


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The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day virtual public workshop entitled, “Topical Drug Development – Evolution of Science and Regulatory Policy 2” on July 23-24, 2020. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss recent advances in the assessment of dermal absorption using in vivo, in vitro, and in silico

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Advancing Animal Models for Antibacterial Drug Development – 03/05/2020 – 03/05/2020


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Event Location

White Oak Campus: The Great Room

Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States

Summary: The Food and Drug Administration is holding a public workshop entitled “Advancing Animal Models for Antibacterial Drug Development.” The purpose of the public workshop is to discuss progress and challenges in the development and advancement of various animal models for serious infection funded by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA). This workshop is a follow up to the

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