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April 2019

FDA/Xavier MedCon 2019

April 30 - May 3
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 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. MedCon includes Data Integrity Master Class, Breakthrough Supply Chain Performance Workshop, and conference sessions. Click here to learn more and register.

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NAMSA Webinar: How to Select the Right EU Notified Body for IVDR Compliance

April 30 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on How to Select the Right EU Notified Body for IVDR Compliance on April 30 at 10am EST. The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746). Topics to be covered during this webinar include: The role of an EU Notified Body overseeing the IVD Regulation (2017/746); Current challenges Notified Bodies are facing…

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May 2019

MDMA 2019 Annual Meeting

May 1 - May 3
InterContinental Hotel – The Wharf, 801 Wharf Street SW
Washington, DC 20024 United States
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Plan to attend MDMA’s 2019 Annual Meeting in our Nation’s Capital, May 1-3, 2019. 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 meeting will provide the latest on regulatory, reimbursement, compliance and international trends, as well interactive sessions with top policy makers from FDA, CMS and more. Do not miss what has become the must-attend event for med tech executives to interact with Members…

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BioPharma Boot Camp: Accelerating your Roadmap to Commercial Success

May 1 @ 8:30 am - 11:30 am
Global Center for Health Innovation, 1 St. Clair Ave., NE
Cleveland, OH 44114 United States
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 BioPharma Boot Camp: Accelerating Your Roadmap to Commercial Success on May 1 from 8:30 - 11:30am CSSi, Ulmer & Berne LLP, and BioEnterprise are hosting a workshop designed for professionals in early and later stage life science companies. This informational event will provide you with the foundation needed to understanding the importance of a strategic roadmap and the requirements to successfully develop and commercialize a new medical technology, drug or biologic. Corporate structuring, finance and deal term development Negotiating a…

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CincyBright 2019

May 16 @ 8:15 am - 1:30 pm
Union Hall, 1311 Vine Street
Cincinnati, OH 45202 United States
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CincyIP is proud to present its first technology CLE conference, CincyBright, on Thursday, May 16 from 8:15am - 1:30pm. CincyBright's speakers will cover such topics as data privacy and the GDPR, 3D printing and additive manufacturing concerns, cybersecurity threats, preparation and response, and IP due diligence in investment finance. CincyBright will also feature a networking luncheon with round tables for discussion of hot topics. 4.0 Hours of CLE Credit in  Ohio and Kentucky is anticipated. This half-day conference allows you…

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R&Q Webinar: Integrating CERs and Post-Market Surveillance

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

Join BioOhio member R&Q for the webinar Integrating CERs and Post-Market Surveillance on May 28 from 1-2pm. CEP, CER, PMS Plan, PMS Report, PSUR and SSCP: With a variety of new requirements detailed in EU MDR, integrating the clinical, regulatory, and post-market documentation is a difficult and confusing task for both small and large organizations. There are overlapping requirements and consistent information needs to be included in a variety of plans and reports. R&Q will explain how the data inputs and…

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June 2019

BIO International Convention 2019

June 3 - June 6
Pennsylvania Convention Center, 1101 Arch Street
Philadelphia, PA 19107 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 2019 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry thought-leaders with over 500 education sessions at your fingertips, and unparalleled networking opportunities with 16,000+ attendees from 67 countries.…

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AAMI Exchange 2019

June 7 - June 10
Huntington Cleveland Convention Center, E 6th Street & St. Clair Ave NE
Cleveland, OH 44115 United States
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Join AAMI on June 7-10, 2019 at the Huntington Convention Center of Cleveland for AAMI Exchange. AAMI has changed the name of its premier health technology event from the AAMI Annual Conference & Expo to the AAMI Exchange. The new name and brand promise reflect the Association's commitment to connect the full gamut of AAMI stakeholders—biomedical and clinical engineers, technicians, cybersecurity and sterilization experts, and hospital administrators and managers and the industry's leading service and solution providers. The Exchange will…

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AdvaMed Webinar: China Adverse Event and PMS

June 12 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member AdvaMed on June 12 from 1-2pm EDT for the webinar China Adverse Event and PMS. The session will cover China post market surveillance (PMS).  NMPA (CFDA) has started to put more emphasis on post market supervision than ever before. Three key areas will be discussed: adverse events (AE), recalls and overseas inspection.  Two key regulations were issued in the past year on AEs and overseas inspection. We will cover key requirements of the regulations, discuss its implications…

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NAMSA Webinar: How to Implement an Effective Internal Audit Program

June 19 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA on June 19 from 11am - 12pm EST for the webinar How to Implement an Effective Internal Audit Program. An organization’s internal audit program is more than meeting the requirements of the 21 CFR 820, ISO 13485 or ISO 9001 standards. An effective internal audit program is an essential part of an effective Quality Management System (QMS), and can be a key communication tool in the promotion of continual improvement throughout the organization, as well as provide insight in areas of…

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