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February 2019

R&Q Webinar: What is sufficient clinical evidence to meet the EU MDR?

February 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for the webinar What is sufficient clinical evidence to meet the EU MDR? on February 26 at 1 pm. The EU MDR lays out requirements for a proactive post-market surveillance system that inputs into the ongoing risk management and clinical evaluation processes throughout the device lifecycle. This session will address the expectations for sufficient clinical evidence and the opportunities, risks, and challenges associated with each. Additionally, we’ll cover requirements for PMS planning and PMS reporting for all…

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Ohio Bioscience Networking Social at AtriCure

February 26 @ 4:30 pm - 6:30 pm
AtriCure Corporate Headquarters, 7555 Innovation Way
Mason, OH 45040 United States
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Join BioOhio and AtriCure for a fun networking social in Mason, Ohio! This event brings the region's bioscience players together for networking, talking shop, and getting to know one another in a casual atmosphere. Food, beverages, and tours of AtriCure's headquarters will be provided. Click here to learn more and register! Please note that BioOhio is hosting a career fair at the Mason Municipal Center on this same date, from 2-5pm. Before heading to the social, feel welcome to stop by the…

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March 2019

WDSrx Ribbon-Cutting Celebration – Lockbourne OH

March 6 @ 10:00 am - 11:00 am
WDSrx, 5653 Creekside Parkway
Lockbourne, OH 43137 United States
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Celebrate the expansion into Ohio of the pharmaceutical logistics services firm, and BioOhio member, WDSrx at a ribbon-cutting at their newest facility located in Lockbourne in beautiful Franklin County. WDSrx, Woodfield Distribution LLC, provides integrated third party logistics pharmaceutical services and value-added solutions empowering the Life Sciences industry. Supply chain operations include Warehousing, Storage, Fulfillment, Transportation Management, Temperature Regulated Environments, Reverse Logistics and Regulatory Compliant Product Disposition. Value-added solutions include on-site Packaging and Labeling, Clinical Trial Support, Customer Service, Patient Assistance Programs,…

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GlobalReach: Exporting Chemicals and Hazardous Materials

March 7 @ 8:30 am - 2:00 pm
Austen BioInnovation Institute in Akron, 47 North Main Street
Akron, OH 44308 United States
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Join BioOhio leadership member Cleveland State University for GlobalReach: Exporting Chemicals and Hazardous Materials on March 7 at 8:30 am. Do you export chemicals, polymers, or other hazardous materials? Are you a prospective exporter of these products? Have you thought about tackling a new foreign market but are getting bogged down by regulatory hurdles and ambiguity? Do you struggle to maintain compliance with material safety data sheets? If any of this rings true for you and your company, you will not…

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Nationwide Children’s Hospital Therapeutics Showcase

March 7 @ 1:00 pm - 5:00 pm
The Blackwell Inn, 2110 Tuttle Park Place
Columbus, OH 43210 United States
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Join BioOhio leadership member Nationwide Children's Hospital for the Therapeutics Showcase on March 7 from 1-5pm. This event will feature: Six talks highlighting novel therapeutic interventions from Nationwide Children's researchers Panel: Affordability and Accessibility of Curative Therapies David Lennon, PhD, President, AveXis Julie Kendle, PharmD, Pharmacy Director in Clinical Drug Assessment, AETNA Michael Storey, PharmD, MS, BCPS, Coordinator, Medication Use and Formulary Management, Nationwide Children's Hospital Moderator: Chet Kaczor, PharmD, MBA, Chief Pharmacy Officer, Nationwide Children's Hospital Schedule 1 pm –…

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Squire Patton Boggs Venture Law Meetup – Donuts and Coffee Series: Stock Options and More

March 8 @ 8:00 am - 10:00 am
Squire Patton Boggs – Key Tower, 4900 Key Tower, 127 Public Square
Cleveland, OH 44114 United States
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Please join BioOhio member Squire Patton Boggs for their monthly Venture Law Meetup – Donuts and Coffee Series. This month’s topic is “Stock Options and More – The Basics for Start-ups.” Joe Yonadi and Matthew Secrist will discuss this topic in a panel moderated by Leah Brownlee. This series aims to equip executive officers and founders of new start-ups with the knowledge and tools needed to navigate the various aspects of launching and growing a new venture. This event is complimentary and includes…

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2019 Molecular Medicine Tri-Conference

March 10 - March 15
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
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Join over 3,700 drug discovery, development & diagnostics professionals worldwide at the 26th International Molecular Medicine Tri-Conference! Since its debut in 1993, the annual Molecular Medicine Tri-Conference has become one of the world's leading international events in the field of drug discovery, development and diagnostics. The Tri-Conference unites an ecosystem of 3,700 innovative thinkers and thought leaders throughout biotech, pharma and academia from around the world. Spanning five days, the 2019 Tri-Conference includes compelling talks, including case studies and joint…

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2019 Bio-IT World West Conference & Expo

March 10 - March 15
Moscone Center, 747 Howard Street
San Francisco, CA 94103 United States
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Bio-IT World Conference & Expo has established itself as a premier event showcasing the myriad IT and informatics applications and enabling technologies that drive biomedical research, drug discovery & development, and clinical and healthcare initiatives ... and now the Bio-IT World Expo is on the West Coast! Join us for compelling talks, including best practice case studies and joint partner presentations, from your fellow industry and academic colleagues discussing themes of big data, smart data, cloud computing, trends in IT…

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FDA/Xavier PharmaLink 2019

March 12 - March 15
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join Xavier Health to engage in rich discussion with FDA and industry leaders so you can walk away with solutions to your toughest challenges! Register now for FDA/Xavier PharmaLink Conference, March 12-15, 2019. PharmaLink 2019 Agenda Highlights Engage in paradigm-shifting dialog that leads to practical supply chain solutions you can implement today, such as: FDA Quality Metrics Program: FDA Gemba Journey with Industry through Feedback and Site Visit Options. MHRA Strategic Priorities and Trends that Impact You Every Day FDA…

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2019 MDMA FDA Forum

March 14 - March 15
Crowne Plaza Cabana Hotel, 4290 El Camino Real
Palo Alto, CA 94306 United States
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Join us at MDMA’s popular TWO day FDA Forum on March 14-15, 2019 in Palo Alto, CA. MDMA’s FDA Forum focuses on unique insights and strategies to govern the 510(k) and PMA regulatory pathways, as well as FDA reform efforts and more. This forum offers numerous interactive panels led by FDA officials, industry leaders and policy experts. Click here to learn more and register. BioOhio members are eligible for a $100 discount off the registration. Contact lreitz@bioohio.com to learn more.

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Pittcon 2019

March 17 - March 21
Pennsylvania Convention Center, 1101 Arch Street
Philadelphia, PA 19107 United States
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This dynamic global event offers a unique opportunity to get a hands-on look at the latest innovations and to find solutions to all your laboratory challenges. The robust technical program offers the latest research in more than 2,000 technical presentations covering a diverse selection of methodologies and applications. Pittcon also offers more than 100 skill-building short courses in a wide range of topics and the once-a-year chance to network with colleagues. Pittcon, a vital resource for knowledge, happens yearly to…

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VWR Webinar: Designing Novel Fluid Sampling Systems for GMP Operations

March 19 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

Join BioOhio member VWR for the webinar Designing Novel Fluid Sampling Systems for GMP Operations on March 19 at 9am EST. Sampling is a requirement in every process step of biopharmaceutical manufacturing, with an increasing demand on accuracy the closer it comes to final finish. The webinar demonstrates a 4-step process, to develop a highly efficient and accurate sampling system. Get a deep insight into the lifecycle of product development design: Product conceptualization considerations Engineering design and proof of concept Quality…

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NAMSA Webinar: Design Control: Understanding the Benefits of Starting Early and Why it’s Necessary

March 20 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on Design Control: Understanding the Benefits of Starting Early and Why it's Necessary on March 20 at 11 am. While design control has been a quality system requirement since 1996, many medical device organizations struggle to understand these requirements, as well as when to start the process and how to maximize the benefits of the system. For example, it is often mistaken that a design control process must be complex to meet the regulatory requirements and to ensure delivery of a…

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R&Q Webinar: Biocompatibility: EU MDR and the changing regulatory landscape

March 26 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on Biocompatibility on March 26 at 1pm EST. This webinar will dive into the increased specificity of the EU MDR from a biocompatibility perspective and how the revised 10993-1 fits into the new requirements. We will share our experiences from the viewpoint of testing laboratory experts and regulatory consultants with biocompatibility experience from both science and regulatory affairs backgrounds. Our goal is to help you understand the changing regulatory landscape in light of…

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Xavier Health EU MDR Workshop 2019

March 27 - March 28
Cintas Center at Xavier University, 1624 Herald Ave.
Cincinnati, OH 45207 United States
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Join BioOhio partner Xavier Health for the EU MDR Workshop in Cincinnati March 27-28, 2019. Experts Bassil Akra (TÜV SÜD), Philippe Auclair (Abbott), Gert Bos (Qserve), and Kim Trautman (NSF), will lead you through the development of a time-critical action plan for keeping your medical devices on the EU market using proven strategies and tactics. At this workshop, you will develop advanced strategies to effectively work with notified bodies; insightful game plans for compiling the data required to certify your products;…

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April 2019

Squire Patton Boggs Venture Law Meetup – Donuts and Coffee Series: Enhancing Capabilities and Accelerating Pace to Market

April 12 @ 8:00 am - 10:00 am
Squire Patton Boggs – Key Tower, 4900 Key Tower, 127 Public Square
Cleveland, OH 44114 United States
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Please join BioOhio member Squire Patton Boggs for their monthly Venture Law Meetup – Donuts and Coffee Series. This month’s topic is “Enhancing Capabilities and Accelerating Pace to Market.” Leah Brownlee will be joined by BioOhio leadership member Cleveland Clinic Innovations to discuss this topic. This series aims to equip executive officers and founders of new start-ups with the knowledge and tools needed to navigate the various aspects of launching and growing a new venture. This event is complimentary and includes a sampling of Cleveland’s…

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Bio-IT World 2019

April 16 - April 18
Seaport World Trade Center, 200 Seaport Boulevard
Boston, MA 02210 United States
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The Bio-IT space right now is rife with hype. Blockchain, AI, machine learning, data science, deep learning, edge, IoT, and more are being touted as panaceas, sure to at least facilitate a cure for what ails you. There are some legitimately cool technologies maturing in our space, but there is also plenty of smoke and mirrors designed to conceal the tech growing pains. At Bio-IT World we strive to clear the air with in-depth technical presentations in 18 tracks, education…

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2019 Medical Capital Innovation Competition

April 17 - April 18
Global Center for Health Innovation, 1 St. Clair Ave., NE
Cleveland, OH 44114 United States
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Join BioOhio member BioEnterprise, in partnership with Cuyahoga County, JumpStart and HIMSS, for the 2019 Medical Capital Innovation Competition April 17-18. The Medical Capital Innovation Competition is an annual two-day event that draws professional and collegiate teams from across the globe to pitch ideas with the potential to transform the future of healthcare. Bringing their best ideas for healthcare application of AR, VR and XR technologies, MCIC teams receive access to meaningful mentoring, co-development opportunities and cash prizes totaling $100,000. 2019…

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NAMSA Webinar: Use of OUS Clinical Data in Medical Device Product Development

April 17 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on the Use of OUS Clinical Data in Medical Device Product Development on April 17 at 11 am. In February 2018, the U.S. Food & Drug Administration (FDA) issued a final rule on an updated regulation pertaining to the acceptance of data from clinical investigations conducted outside the United States (OUS) to support IDEs or submissions (i.e., PMAs). While it is common for medical device manufacturers to utilize OUS clinically applicable data (including clinical…

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SBIR Workshop: Life Science and Health Care Technologies, presented by OAI

April 18 @ 8:30 am - 4:00 pm
Ohio Aerospace Institute, 22800 Cedar Point Road
Cleveland, OH 44142 United States
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Join BioOhio member Ohio Aerospace Institute for an SBIR Workshop on April 18 from 8:30am - 4pm. This day-long workshop is for small businesses seeking to understand the nuances and best strategies for successfully competing for the Nation's largest seed fund: between the National Institute of Health (NIH), National Science Foundation (NSF), Department of Defense (DOD) and other agencies, approximately half of the $2.5 - billion SBIR/STTR funding is directed at health care and life science innovations. Learn from former…

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