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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

2018 MDMA FDA Forum

March 12 - March 13
Crowne Plaza Cabana Hotel, 4290 El Camino Real
Palo Alto, CA 94306 United States
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Have you ever left a conference and realized that you forgot to ask the question you came to get answered? Ever wonder what the FDA’s criteria may be when reviewing your PMA/510(k) submission? Join us at MDMA’s FDA Forum on March 12-13, 2018 in Palo Alto, CA to get your questions answered. MDMA’s 2018 FDA Forum continues to grow as THE conference to engage with leading policy makers and experts. Be sure not to miss out hearing from EIGHT FDA…

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2018 FDA/Xavier PharmaLink Conference

March 13 - March 16
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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At PharmaLink, we work to find solutions that will increase confidence in your product quality throughout your global supply chain. We do this by aligning with the strategic priorities of the Food & Drug Administration. We help participants create links to drive new thinking. The solutions might not be evident within our industry, so we explore beyond our industry, beyond borders, and beyond comfort zones. Don’t miss this opportunity to join your colleagues and global regulators from around the world…

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Xavier Health: 2018 Data Integrity Master Class

March 13 @ 8:00 am - 4:00 pm
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join Xavier Health the day before the FDA/Xavier PharmaLink conference, for the Data Integrity Master Class, Tuesday, March 13, 2018, from 8am-4pm, at Xavier University. John Avellanet, who trains the FDA on how to find data integrity issues in companies worldwide, will provide answers, examples and steps to take today to reduce your risk to your company products and patient. Arrive at 7:30am and enjoy a complimentary warm breakfast before the class starts. Register today for this very interactive class,…

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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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May 2018

Xavier Health: 2018 Case for Quality Workshop

May 1 @ 11:30 am - 4:00 pm
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join Xavier Health the day before the FDA/Xavier MedCon conference, for the Case for Quality Workshop, Tuesday, May 1, 2018, from 11:30am-4pm EST, at Xavier University. In 2011, CDRH launched the Case for Quality initiative in an effort to shift the focus of industry and FDA from one of compliance and enforcement to one of quality ownership, based on the concept that a focus on quality ownership will improve product quality and patient safety, while naturally resulting in compliance. As…

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August 2018

Xavier Health AI Summit 2018

August 23 - August 24
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join FDA and Industry Experts to Develop Quality, Regulatory, and Supply Chain Solutions Through the Power of AI. AI Realized. The Xavier Artificial Intelligence Initiative presents AI Summit 2018, August 23-24. Be a part of the future of our industry by: Understanding the current use of AI in the medical device and pharma industries Exploring cutting-edge possibilities of how the power of AI can be applied to solve your challenges in quality, regulatory, and supply chain Engaging in AI industry-wide…

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October 2018

Xavier Health Cybersecurity Summit 2018

October 23 - October 24
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join Xavier Health at the 2018 Cybersecurity Summit, collaborating to secure data, prevent threats, and protect the patient. Protect Your Products and Patients Today from Cybersecurity Threats Join FDA and industry thought-leaders to address the most pressing challenges that threaten the quality of your products and expose your patients to life-threatening risks. FDA has identified the Xavier Cybersecurity Summit as an “important” one-of-a-kind summit that will drive deep “how to” discussions, enabling participants to walk away with actionable solutions. Be…

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December 2018

Future Event Testing

December 7 @ 8:00 am - 12:00 pm
Rev1 Ventures, 1275 Kinnear Road
Columbus, OH 43212 United States
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Free

This page is being used as a sandbox to test new registration systems and is not an actual event.

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