Boston Area RA professionals please join us April 10 2pm in-person for ??Warp-speeding Regulatory Decisions and Responding to FDA Refuse to File Determinations on an NDA or BLA?? Burlington, MA. Register today at the link below! https://lnkd.in/eAw_3xAX
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RAPS CHAPTER SURVEY RELAUNCH - Please COMPLETE the RAPS Chapter survey by this Friday February 7th There was a glitch in the original survey sent out at the end of 2024 and as such the results could not be compiled. So even if you have completed this last year please do so again so we get your feedback. It only takes a few minutes to complete. Please remember to use the email with your personalized access link! (You should have received a reminder on Feb 4 and the original survey link would have arrived to your inbox Jan 21) Look for an email from RAPS with the subject line “Help Us Improve Your RAPS Chapter & LNG Experience?” We want to hear from you!
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Happy New Year RAPS Boston chapter! The leadership team of the Boston chapter has been diligently working behind the scenes to create some great regulatory programming for 2025. We are working on Pharma and medical device educational events and we hope to share some more specifics soon. Although we have no lack of ideas for events, we do have an area where we wanted to reach out to the RAPS Boston member community for some help. We are looking for location(s) in and around the greater Boston area for in person meetings where a company or organization would have space and be willing to host a meeting at no or very low cost. Funding for our events come from the attendance fees. So in all transparency, securing a low cost or no cost space is essential to keeping the cost of attendance affordable for our membership. Alternatively, or in addition, if your company is interested in sponsoring or co-sponsoring one of our in person events, then that would give our events and education teams flexibility in organizing the events and keeping our costs down. If you can offer some help in this area please reach out to me and I will pass this information to our vice chair of events. Looking forward to an exciting 2025 at RAPS Boston. Best regards, Joel Kent Chair, RAPS Boston Chapter
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FYI Boston Chapter medical device folks.
Heads up out there! There is a new version of the FDA eSTAR tool out today. Version 5.4 is released. Pay close attention to the version history and the device description help text to make sure your submissions won’t fall victim to potential technical screening deficiencies. https://lnkd.in/dbTbSGy7
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Excited to share I have appointed Chair of the RAPS Boston Chapter. Looking forward to leading a great team of volunteers to help bring educational and networking events to the Boston area RA professionals.
Excited to share I have been appointed Chair of the RAPS Boston Chapter. Looking forward to leading a great team of volunteers to help bring educational and networking events to the Boston area RA professionals. Volunteering for the Regulatory Affairs Professionals Society (RAPS) is fun and fulfilling - please comment below or message me if you would like to learn more or get involved.
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Great reminder Cheri! Boston area RAPS members we need your input, and this survey will help the new leadership team to create local content and event topics that most interest you at the most accessible times and places to meet your needs. "The ear of the leader must ring with the voices of the people." - President Woodrow Wilson.???
Wearables | Digital Health | Partnerships & Strategy | SaMD | Medical Device | Building Business Models for Digital Health | Product Development | Regulatory Affairs & Compliance | AI
RAPS Boston chapter members- Please remember to complete the needs assessment. The survey link was sent in email. #regulatoryaffairsprofessionalssociety Jenifer Fernandes Joel Kent David Leo Scott Blood Attrayee C.
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We are very excited to announce the New RAPS Boston Chapter Leadership Team. As we "relaunch" the chapter we are all excited to bring regulatory educational and networking opportunities to our collegues in the area. Our town hall in August and our virtual kick-off webinar on eSTAR with the FDA showed strong support from our local community of professionals and we look forward to what the upcoming year will bring. We are planning in-person networking and educational opportunities for 2025. Thank you for all your support. Stay tuned!! Joel Kent : Chair Scott Blood: Chair Elect Cheri-Anne Malo: Vice Chair Education Niraj Ramachandran: Vice Chair Events Jenifer Fernandes: Vice Chair Membership Attrayee Chakraborty: Treasurer David Leo: Chapter Advisor
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Never done an eSTAR submission? Want to know more if you’ve already completed one? Get both industry and an FDA perspective by joining the RAPS Boston Chapter as we host a virtual webinar October 9 starting at 12:00N EST ??Shining light on eSTAR submissions – An FDA reviewer and industry discussion.?? Anyone may join! RAPS Member: $0 | Nonmember: $25 Link below to register. https://lnkd.in/dp8Z3Sbz