RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Upcoming Events

Past Events
  • Chapter Events

    Boston Chapter Webcast: IMDRF/Health Canada Updates

    • 08 April 2020
    Eat your lunch and join the RAPS Boston Chapter online to learn from two medical device experts from Health Canada as they provide updates on the activities and direction of the International Medical Devices Regulators Forum (IMDRF).
    1.0 RAC Credits
    REGISTER
  • Online Workshop

    Software as a Medical Device

    • 15 April 2020 - 16 April 2020
    Navigating expectations for software products is particularly challenging and requires a different approach from other medical devices. This workshop will review the evolving regulatory requirements globally for software as a medical device (SaMD).
    12.0 RAC Credits
    REGISTER
  • Live Webcasts

    Sponsored Webcast: PMS Requirements of the EU MDR: Implementation Challenges and Solutions

    • 15 April 2020
    We have a choice: Continue to apply Band-aids to our PMS processes and procedures, or think long-term and get it right for good. We're sharing several real examples that have worked and know what the notified bodies actually want to see.
    1.5 RAC Credits
    REGISTER
  • Chapter Events

    Indiana Chapter: Lunch and Learn Webcast: Implementing Risk-Based Decision Making

    • 16 April 2020
    Review the recent edition of ISO 13485 Medical Devices quality management systems requirements for regulatory purposes, which introduces the concept of a risk-based approach to decision making.
    1.0 RAC Credits
    REGISTER
  • Online Workshop

    Biologics CMC: Phase Appropriate Product Development Challenges

    • 23 April 2020 - 24 April 2020
    This workshop provides an overview of product development challenges and regulatory expectations in the US and other regulated regions which will equip attendees with knowledge to handle technical issues affecting biologic product development.
    12.0 RAC Credits
    REGISTER
  • Meetings

    2020 MDMA Annual Meeting

    • 29 April 2020 - 01 May 2020
    • Washington, DC, USA
  • Boston Chapter Webcast: Navigating China’s Regulatory Landscape Under NMPA Regulations

    • 29 April 2020
    Eat your lunch and join the RAPS Boston Chapter online to dive more deeply into the challenges that regulatory professionals face when working on submissions to China’s National Medical Products Administration (NMPA).
    1.0 RAC Credits
    REGISTER
  • Meetings

    Executive Development Program at the Kellogg School of Management

    • 17 May 2020 - 20 May 2020
    • Evanston, Illinois, USA
    The only leadership program dedicated to regulatory professionals like you that combines regulatory experts with faculty from one of the most prestigious business schools in the US, the Kellogg School of Management at Northwestern University.
    12.0 RAC Credits
    REGISTER
  • Online Workshop

    Introduction to Electronic Regulatory Submissions in the eCTD Format - July 2020

    • 14 July 2020 - 15 July 2020
    Organizations need to understand both the underlying CTD structure and their options for implementing operational changes that will lead to successful electronic applications. Join RAPS for a two-day workshop on regulatory submissions in eCTD format.
    8.0 RAC Credits
    REGISTER
  • Online Workshop

    Intermediate Course for Regulatory Submissions in eCTD Format - July 2020

    • 16 July 2020 - 17 July 2020
    If you have a working knowledge of the CTD structure and need to learn how to correctly apply it to electronic submissions, or if you need to know what is required to comply with the FDA’s May 2020 guidances, this two-day workshop is for you.
    10.0 RAC Credits
    REGISTER
  • Meetings

    RAPS Regulatory Convergence 2020

    • 12 September 2020 - 15 September 2020
    • San Antonio, Texas, USA
    Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
    12.0 RAC Credits
    LEARN MORE
  • Online Workshop

    Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges - September 2020

    • 29 September 2020 - 30 September 2020
    This workshop provides an overview of chemistry, manufacturing and control (CMC) regulatory requirements and best practices associated with biologic and biosimilar products, with emphasis on requirements in the US, Europe and other regulated regions.
    12.0 RAC Credits
    REGISTER