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February 2018

NAMSA Webinar: How to Use Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

February 21 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for this webinar on February 21 from 1-2 PM. Often, real-world data (RWD) routinely collected during patient treatment and management provides tangible information pertaining to the experiences of medical device end-users. These data sources range from medical device registries, electronic health records (EHRs), claims and billing data, patient-generated information, and even data gathered from mobile devices. Under the right conditions, information derived from these sources can be utilized to support various medical device regulatory pathways and…

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R&Q Intelligence Series Webinar: Technical Documentation for EU MDR

February 27 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

This webinar will provide the background and requirements that medical device manufacturers will need for their technical documentation to meet the requirements of the European Medical Device Regulations (EU MDR). This is designed to set the foundation for your planning of next steps to keep your product on the market in Europe. It's time to know the essential EU MDR requirements. It's also time to plan and act. The upcoming EU MDR changes are significant, potentially impacting your device classification…

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Webinar: Benefit Trends and Strategies for Life Sciences Organizations

February 28 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio member Aon for the webinar Benefits Trends and Strategies for Life Sciences Organizations on February 28 at 2PM. For life sciences organizations, devising an effective and engaging employee benefits strategy can be especially difficult in today’s environment. Mobile and diverse workforces, multiple locations, multi-generational employees, manufacturing concerns, and union-related issues are just some of the additional variables adding to the complexity of this challenge. Join Aon experts as they discuss how life sciences organizations can take on these…

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March 2018

G2G Webinar: Military Medical Funding – How it Works & What You Need to do Now to Prepare for MHSRS 2018

March 6 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Please join BioOhio member G2G for a webinar on March 6 from 12-1pm. Once you RSVP with gkapcar@G2Gconsulting.com, you will receive the link to participate in the webinar. This webinar will give you an up-to-the-minute analysis of what is happening with the federal budget process and timing for the coming year, best opportunities for biosciences, and preparation for successful participation in the largest military medical R&D conference hosted by the Military Health System Research Symposium (MHSRS). Submitting an abstract and being selected…

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Webinar – Combination Product Updates

March 20 @ 3:00 pm - 4:30 pm
Webinar Online Event, OH United States

Join the FDA on March 20 for the webinar Combination Product Updates for “Acceptance and Filing Reviews for Premarket Approval Applications” and “Refuse to Accept Policy for 510(k)s”. On January 30, 2018, the FDA issued updated final guidance documents: Refuse to Accept Policy for 510(k)s Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) These guidance documents explain the procedures and criteria the FDA intends to use in accepting or refusing a 510(k) or PMA submission. It includes checklists to identify…

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