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February 2018

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: Getting Treatment Options to Rare Disease Patients Faster: Putting Patients First in Clinical Trials

February 28 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

The theme for Rare Disease Day, February 28, 2018 is “research.” In clinical research, the relationship between patient and researcher is symbiotic – the patient community needs researchers for cures and treatments and researchers need patients to participate to ensure meaningful outcomes. With rare disease, this relationship is intensified on both sides: patients and their caregivers often have few treatment options while researchers have a smaller pool of potential participants. Join us on Rare Disease Day as experts from Medpace,…

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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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ADM Cleveland

March 7 - March 8
Huntington Cleveland Convention Center, E 6th Street & St. Clair Ave NE
Cleveland, OH 44115 United States
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Northeast Ohio's Only Comprehensive Design and Manufacturing Event The Advanced Design and Manufacturing (ADM) Cleveland will deliver the full spectrum of advanced design and manufacturing technology under one roof. Built to give engineers and executives access to the latest solutions at any point in the product development process, it will offer cutting-edge technologies, networking events, and educational opportunities within robotics, automation, plastics, packaging, and design technology — as well as within key industry verticals such as automotive, medtech, and aerospace.…

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2018 Health Sciences Technology Showcase presented by Nationwide Children’s Hospital

March 7 @ 1:00 pm - 5:00 pm
Rev1 Ventures, 1275 Kinnear Road
Columbus, OH 43212 United States
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Nationwide Children's Hospital invites you to attend the 2018 Health Sciences Technology Showcase, featuring inventors from the institution who will be presenting on solutions to leading issues within the healthcare industry. A reception and networking will follow the presentations. Keynote speaker:  Brian Kaspar, PhD, Chief Scientific Officer, AveXis, Inc. Additional details will be added as the event draws closer.

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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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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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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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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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Precision Genomics Midwest 2018

May 11
To be announced TBA, OH United States

Save the Date for 2018 Conference 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. Click here to learn more.

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June 2018

BIO International Convention 2018

June 4 - June 7
Boston Convention & Exhibition Center, 415 Summer Street
Boston, MA 02110 United States
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The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. The key benefits of attending the 2018 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry though-leaders with over 1,500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 74 countries. As a valued…

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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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September 2018

Xavier Health Combination Products Summit 2018

September 11 - September 13
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join Xavier Health for the Combination Products Summit on September 11-13. Collaborate with experts. Walk away with solutions in-hand. Experience the Xavier Difference at CPS: Interact with FDA and industry experts. Network with your colleagues and share challenges. Accelerate your product approval by learning about new streamlined FDA processes. Work through an advanced case study and participate in deep dive sessions with the experts. Create action plans to implement right away. Register now for Combination Products Summit 2018, happening September…

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Life Sciences Baltics International Exhibition 2018

September 26 - September 27

Life Sciences Baltics 2018 is the only international forum in the Baltics for world-class biotechnology, pharmaceutical and medical devices experts from all around the world. It provides a unique opportunity to explore the new horizons of partnerships, exchange ideas and seek progress through networking. Discover enormous potential and passion in the field of life sciences in Lithuania and the Baltics – the gateway to emerging markets. Exhibitors at Life Sciences Baltics 2018 will: Gain the visibility and increase its brand…

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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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