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March 2018

Demystifying the Compassionate Use Device Exemption Process

March 14 @ 5:30 pm - 6:30 pm
Cincinnati Eye Institute, 1945 CEI Drive
Cincinnati, OH 45242 United States
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Join the Cincinnati Chapter of the Association of Clinical Research Professionals for a presentation on Perspectives of an Investigator, Research Coordinator, & the IRB on Compassionate Use Device Exemption Process. This Presentation has been submitted for consideration of 2 CE credits through ACRP. To RSVP, please contact Jessica Wessel, jlwessel@cincinnatieye.com.

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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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2018 Engineering in Healthcare: Industry & Research Symposium, presented by BMES

March 22 @ 10:00 am - 4:30 pm
Ohio Union, 1739 N High St
Columbus, OH 43210 United States
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On March 22nd, the Biomedical Engineering Society at Ohio State will be holding their 3rd annual Engineering in Healthcare: Industry and Research Symposium (EH: I&RS). This event showcases exemplary research from engineering graduate and undergraduate students and facilitates networking between students, faculty, industry representatives, and the public. The EH: I&RS is a prime event to gain a foothold in the OSU health care initiatives, increase your talent pool amongst students, develop new collaborations with faculty or promote new innovations in…

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University of Toledo Careers in Science Event, featuring Assurex Health

March 27 @ 1:00 pm - 4:30 pm
University of Toledo Student Union Auditorium, 2801 West Bancroft Street
Toledo, OH 43606 United States
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The University of Toledo Graduate Student Association Department of Biological Sciences presents Careers in Science Day. The event is taking place March 27, 2018 at the Student Union Auditorium, featuring speaker Sandra Gunselman, VP Laboratory Operations  at Assurex Health. A graduate degree in biology can take you down many paths, ranging from what is considered the “traditional route,” academia, to the “alternative options,” which can vary from careers in big pharmaceutical companies, to editing and consulting positions.  Because of the…

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R&Q Intelligence Series Webinar: Risk Management Updates

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

Join BioOhio member R&Q on March 27 for their Intelligence Series Webinar: Risk Management Updates. This webinar will provide the background and requirements that medical device manufacturers will need for creating, updating or otherwise remediating the risk management files to meet the requirements of the European Medical Device Regulations (EU MDR), In vitro Diagnostic Regulation (IVDR) and other worldwide requirements. This presentation is designed to set the foundation for your medical device risk management files in alignment with Clinical Evaluation Reports…

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NAMSA Webinar: Leveraging Post-Market Data to Support EU MDR Compliance

March 28 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for Leveraging Post-Market Data to Support EU MDR Compliance on March 28 at 10AM. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities have historically been a critical part of conformity with the Medical Device Directive 93/42 EEC (MDD) and Active Implantable Device Directive 90/385/EEC (AIMD). However, over the last year, there has been an increased emphasis on PMS and PMCF compliance initiatives under the new EU Medical Device Regulation 2017/745 (MDR). The amplified focus on…

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Ohio Manufacturers’ Association Webinar: Setting Your Industry Sector Partnership Strategy, A Case Study

March 28 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join the Ohio Manufacturers' Association for Setting Your Industry Sector Partnership Strategy, A Case Study, a webinar on Wednesday, March 28 from 10:00 - 11:00 a.m. Manufacturers across Ohio are embracing Industry Sector Partnerships as a strategy to solve workforce issues. In this webinar, participants will hear from one of Ohio’s established partnerships, ConxusNEO, to learn how local manufacturers are collaborating with area workforce suppliers to solve pressing talent and skill shortages. Please join us to learn how the industry sector…

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April 2018

NAMSA Webinar: Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1

April 11 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on April 11 for the webinar Understanding the Use & Value of Biocompatibility Standards for Medical Devices under ISO 10993-1. Historically, biological safety evaluations for medical devices were comprised of an investigation into biocompatibility tests required to meet regulatory obligations. Put simply, medical product manufacturers would contract with a testing laboratory, evaluate the lab’s proposal and accept the recommended product evaluation plan. In today’s world, however, the simplicity of the above process is increasingly questioned given the…

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How-To Series: Build Products Your Customers Want

April 21 @ 1:00 pm - 5:00 pm
LaunchHouse, 675 Alpha Drive
Highland Heights, OH 44143 United States
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Join LaunchHouse on April 21, 2018 at 1pm for Build Products Your Customers Want, a Design Thinking Workshop. What is Design Thinking? Design thinking is a human-centered approach to creative problem solving. It is a subjective process that allows you to focus on your customers’ needs to create products and services that they want. Design thinking encourages you to create an environment of experimentation that allows you to quickly build and test your solutions with your customers. Why Design Thinking? As…

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R&Q Webinar: EU MDR – Proactive Post-Market Surveillance

April 24 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for April's free Intelligence Series webinar: EU MDR – Proactive Post-Market Surveillance: The requirements and staff it will take to do it. The session will be on Tuesday, April 24ᵗʰ from 1:00pm - 2:00pm EST. The presentation slides, webinar recording, and Q&A will be made available to registrants - whether you can attend the live presentation or not. Webinar details The EU MDR lays out requirements for a proactive post-market surveillance system that that inputs into the ongoing…

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2018 Rev1 Innovation Hop

April 26 @ 4:00 pm - 7:00 pm
Rev1 Ventures, 1275 Kinnear Road
Columbus, OH 43212 United States
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Don’t miss the Fourth Annual Innovation Hop, hosted by BioOhio partner Rev1 Ventures! The buzz about Columbus’ startup scene continues to grow. More tech-enabled, high-growth companies are being built here than ever before. Now is your chance to get to know the entrepreneurs behind the big ideas that have helped put the Columbus region on the map. Rev1 is opening their doors for an evening of networking, education, and enjoyment with some of the best and brightest startups in the Columbus region.…

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May 2018

FDA/Xavier MedCon

May 1 - May 4
Cincinnati Hilton Netherland Plaza, 35 West 5th Street
Cincinnati, OH 45202 United States
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The FDA/Xavier University Medical Device Conference, MedCon, is a conference with formal FDA partnership that engages medical device manufacturers in discussion on how to increase the consistency and reliability of product quality while complying with FDA regulations. There are three key outcomes that we look to deliver through MedCon: Inspiring Collaboration Feel the purpose-driven nature of this summit as soon as you enter the room. Expect orchestrated engagement with your peers across the industry on topics you are passionate about.…

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MedCity INVEST 2018

May 1 - May 2
Four Seasons Hotel Chicago, 120 East Delaware Place
Chicago, IL 60601 United States
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Meet and connect with active investors, corporate development execs and healthcare’s most promising startups at MedCity INVEST—your next stop after the JP Morgan Healthcare Conference. MedCity INVEST is the premier national healthcare investing conference based in the Midwest, uniting active investors with corporate business development executives to facilitate investment opportunities with the most promising healthcare startups. MedCity INVEST will be held May 1-2, 2018 at the Four Seasons, Chicago. For more than a decade, biopharma, diagnostics, health IT, medical devices and…

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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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MDMA 2018 Annual Meeting

May 2 - May 4
Mandarin Oriental Washington, 1330 Maryland Avenue SW
Washington, DC 20024 United States
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Plan to attend MDMA’s 2018 Annual Meeting in Washington, D.C., May 2nd – May 4th. MDMA’s Annual Meeting will cover key issues impacting the United States’ leadership position in med tech innovation, and how we can all help shape the regulatory and legislative agendas. This year’s Opening Address will be given by FDA Commissioner Scott Gottlieb, M.D. who will discuss his vision for the agency, and the latest reforms he and his team are working on. Commissioner Gottlieb is one of…

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2018 Ohio Bioscience Networking Social in Toledo

May 3 @ 4:00 pm - 6:00 pm
Bar 145 – Toledo, 5305 Monroe Street
Toledo, OH 43623 United States
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BioOhio's fun socials bring Ohio's bioscience players together for networking, talking shop, and getting to know one another in a casual atmosphere. Complimentary hors d'oeuvres for all guests; 1 drink ticket for BioOhio members, and that includes employees of member organizations. Cash bar for non-members. 2018 will feature events in Athens, Cincinnati, Cleveland, Columbus, Dayton, and Toledo, Ohio.BioOhio Socials are made possible by generous support of companies and organizations that value the power of partnerships and networking. For information on…

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Drug Development Boot Camp, presented by BioEnterprise and Charles River

May 9 @ 9:00 am - 2:00 pm
HIMSS Innovation Center, 1 St. Clair Avenue, NE
Cleveland, OH 44114 United States
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BioOhio members BioEnterprise and Charles River are proudly hosting a Drug Development Boot Camp at the Global Center for Health Innovation on Wednesday, May 9, 2018. This educational one-day event will provide an overview of the drug discovery and development process, and a practical understanding of how to translate research to clinical development. Industry experts will discuss a variety of drug development topics, including: Target discovery & validation Integrated drug discovery Considerations for in vivo safety toxicology, cardiac safety assays,…

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Precision Genomics Midwest 2018

May 11
Kingsgate Marriott, 151 Goodman Drive
Cincinnati, OH 45219 United States
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The next Precision Genomics Midwest is set for May 11, 2018. Cosponsored by Cincinnati Children’s and the University of Cincinnati, PGM features talks by renowned genomic researchers, clinicians and thought leaders, along with a vendor fair. It is the first Midwest regional conference focused exclusively on genomic research, translation and ethics. Event is free (including lunch) but registration is required because space is limited. Click here to learn more.

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R&Q Intelligence Series Webinar: CERs – Tips, Tricks, and Lessons Learned

May 22 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar CERs – Tips, Tricks, and Lessons Learned on May 22 at 1pm. You have heard about the increased requirements for clinical evaluation with MEDDEV 2.7/1 Rev 4 and the MDR. You may be working on new templates and updating your CERs. And now come the questions... What do these requirements really mean? Why are we doing this? How are we going to get this all done? In this webinar, you’ll get the clinical…

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Renovo Neural Spring Open House

May 22 @ 3:30 pm - 6:00 pm
Global Cardiovascular Innovations Center (GCIC), 10000 Cedar Avenue
Cleveland, OH 44195 United States
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Please join BioOhio member Renovo Neural for an Open House event to discuss Renovo's offerings!

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