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Online Event, OH United States

November 2013

National Cancer Institute SBIR Webinar: Leveraging Opportunities for Early-Stage and Venture-Backed Companies

November 19, 2013 @ 12:00 pm - 1:45 pm
Webinar Online Event, OH United States

NCI SBIR Webinar: Leveraging NCI SBIR & STTR Opportunities for Early-Stage and Venture-Backed Companies On Tuesday, November 19, the Council of State Bioscience Associations (CSBA) is collaborating with the National Cancer Institute Small Business Development Center to provide you and your members an exclusive chance to learn more about the funding opportunities and resources offered by the NCI Small Business Innovation Research (SBIR) Programs. The NCI SBIR Development Center can help progress the development of your novel technologies and therapeutics…

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BioOhio Member Webinar: Why Digital Communications are Changing Healthcare

November 20, 2013 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Why Digital Communications are Changing Healthcare Did you know that 80% of healthcare inquiries start with a search engine... or that 34% of consumers use social media to find health information? Mobile browsing, social media, and search engines have changed the manner in which health organizations engage with patients. Healthcare 2.0 has arrived! Join webinar co-hosts Dennis Schiraldi of Astute Solutions and Bill Balderaz of Fathom as they explore new forms of patient engagement and digital communications as they apply…

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December 2013

AdvaMed Webinar: Raising Capital, Rule 506(c) Solicitation and Advertising and Title III Crowdfunding

December 11, 2013 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

AdvaMed Emerging Growth Company Council (EGCC) Webinar Wednesday, Dec. 11th! Raising Capital - Rule 506(c) Solicitation and Advertising and Title III Crowdfunding Speakers: Carson Porter, Rimon Group PC and Barry Michael, FOCUS Investment Banking LLC Please join us next Wednesday to discuss portions of the JOBS Act! The purpose of this webinar is to help participants be better able to: - Understand current and soon to be made current SEC rules that can improve capital raising opportunities - Discuss why FINRA and…

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January 2014

Webinar – Inside Third Frontier 2014: Mountains of Opportunity, Valley of Death

January 13, 2014 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Have you ever wondered why most companies fail when taking their tech products to market? Thanks to Jon Dudley, Director of Technology Commercialization and Grant Writing at the Montrose Group LLC, we have first-hand experience with many technology startups. Join Montrose Group Founder David J. Robinson and newest team member Jon Dudley to learn what projects Third Frontier is most likely to fund, how to request that funding with grant-writing tips, and how you can avoid the most common mistakes…

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Webinar – ImageIQ presents How to Use Imaging Data to Market Your Medical Device

January 15, 2014 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

As a medical device marketer, do you struggle to differentiate your products from your competition? The data generated for your FDA approval will show that your device is safe and effective, maybe even show that it is different, but rarely will a clinical trial yield data demonstrating how your product is better than your competitors’ – and for a claim like that, the FDA requires objective quantifiable evidence. This valuable data may ALREADY exist in the images acquired during your…

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Webinar – TechSolve presents 4 Ways That Lean Can Provide "Best Care at Lower Cost"

January 23, 2014 @ 11:30 am - 1:00 pm
Webinar Online Event, OH United States

The Institute of Medicine, in its 2012 report Best Care at Lower Cost: The Path to Continuously Learning Health Care in America, concludes that at least $750 billion or 27% of the total national healthcare budget of $2.7 trillion represents WASTE. This is a result of multiple reasons, including supplier rather than patient-centered reimbursement, lack of quality and transparency, and inefficient operations. In this complimentary webinar on January 23rd, Sue Kozlowski, TechSolve’s Director of Healthcare Consulting, and Senior Project Consultant,…

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February 2014

Webinar: 2014 Ohio Policy and Politics Preview

February 21, 2014 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

2014 will prove to be an exciting year for politics and policy in Ohio. Governor Kasich is facing a re-election campaign as well as all the statewide elected officials, 99 Ohio House members and 17 Ohio Senators. A billion dollar tax cut and a billion dollar capital bill are also on the list of policy items topping the agenda and they join municipal income tax reform, alternative energy mandates and a long list of other state policy agenda items. The…

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Webinar: CTI presents Rare Disease Day Free Webinars

February 24, 2014 - February 28, 2014
Webinar Online Event, OH United States

Rare Disease Day - Free Webinars Rare Disease Day is an international advocacy day dedicated to bring widespread attention to rare diseases. From February 24-28, 2014 CTI will be hosting free educational webinars that focus on rare disease and the challenges of drug development in these areas: "Tricks and Traps" for Estimating the Economic Burden of Illness for Rare Diseases (Candace Gunnarsson, EdD - Vice President, Health Economics & Outcomes Research) - Monday February 24, 2014 - 11am - 12pm…

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FDA Q&A Webinar

February 25, 2014 @ 1:00 pm - 2:30 pm
Webinar Online Event, OH United States

presented by BioOhio & REU Associates, in cooperation with the U.S. Food and Drug Administration                     As a follow-up to BioOhio’s Regulatory Forum (October 2013), we are pleased to present this special Q&A session featuring four FDA officials and REU Associates. Representatives from the FDA will be available live to answer your pre-market regulatory and post-market compliance questions. Questions will be collected from registrants in advance of the webinar. The BioOhio Regulatory Forum, in partnership with REU and sponsored by…

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Webinar – TechSolve presents Lean to Acute Care Processes in Rural/Critical Access Hospitals

February 27, 2014 @ 11:30 am - 1:00 pm
Webinar Online Event, OH United States

Rural and critical access hospitals face multiple challenges such as declining human and financial resources, which may seem daunting to overcome if they want to embrace Lean as a system-wide improvement model in their organizations. In this complimentary webinar on February 27, 2014, “Applying Lean to Acute Care Processes in Rural/Critical Access Hospitals”, TechSolve Project Consultants, Laryn Stuart and Lori Kauflin, will discuss how applying Lean Principles to acute care processes can help facilities realize a reduction in waste while…

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March 2014

Webinar: Xavier Health presents Advanced Post-Market Surveillance Solutions

March 6, 2014
Webinar Online Event, OH United States

Presented by the Xavier Health QA RA Institute Post-Market Surveillance is a critical component to effective management of the Total Product Lifecycle of your device. The ultimate goal is to have conducted a thorough approach to design development and manufacturing such that the controls in place ensure the device will be safe and effective once on the market. Post-Market Surveillance is an avenue to provide further intelligence about your device and if it is meeting the expectations of your company.…

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Webinar – TechSolve presents Lean – An Rx for Hospitals Preparing for the Affordable Care Act

March 27, 2014 @ 11:30 am - 1:00 pm
Webinar Online Event, OH United States

The ACA’s provisions change the way hospitals and healthcare systems do business and how they are compensated. Across the board reductions and productivity adjustments will result in massive cuts over the next decade. Lean has proven strategies for revolutionizing healthcare delivery as well as helping with this giant sea-change in the healthcare industry. Lean is a perfect complement for ACA implementation because with Lean: The customer comes first. Patient-centric care is more important than ever. This leads to 360 closed…

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Webinar: The ABC’s of SBIR / STTR Funding

March 27, 2014 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

    Is your technology company eligible for non-dilutive federal funding through the government’s SBIR/STTR program? Join us for this webinar covering SBIR/STTR program basics including: program purpose; eligibility; and sources of funding. It is designed to provide enough information for attendees to determine if they would like to seriously pursue proposal development and tools to help begin the process. For more information and to register, click here.

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Webinar: Impacts of the Farm Bill on the Bioproducts Industry

March 28, 2014 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

    Please join The OBIC Bioproducts Network for our March Webinar: Impacts of the Farm Bill on the Bioproducts Industry This program will feature Brandon McBride, US Senate Ag Committee  Mark Brodziski, Director of Energy Division Rural Business Cooperative Programs, USDA Jeff Goodman Cheif Environmental Management Division, USDA Join us for an online program about impacts of the recently passed farm bill on future bioproducts commercialization. Visit the event website for more information and to register.

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April 2014

Webinar: Document management best practices for emerging life science companies

April 3, 2014 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

  Document Management is an essential and required quality process that all pharmaceutical, medical device, and biotech organizations must address in order to properly support their daily business in a highly regulated environment. Many current electronic systems available for document management are too big a hurdle for startup Life Science companies because of their costs, required upkeep, and continued drain of available resources. Therefore, many rely on internal manual procedures and resources to control their documents, instead of implementing an…

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WEBINAR: 2-day Online Fibromyalgia Workshop sponsored by Sound Health

April 10, 2014 @ 8:00 am - April 11, 2014 @ 5:00 pm
Webinar Online Event, OH United States

A Starter Kit used as a prerequisite to the week-long Professional Seminar Course – It is designed to acquaint the student with the introduction and background of Human BioAcoustics. Through individualized self-instruction and step-by-step guidelines, the information will prepare the student to perform computerized vocal assessments and create management reports. The course includes: Vocal Profiling software used to transform vocal data to numeric data; (Abacus), one of many Vocal Profiling software programs used to interpret data; an instruction booklet; introductory…

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Webinar – TechSolve presents 7 Steps to EHR Success – The Benefits of Lean in EHR Implementation

April 24, 2014 @ 11:30 am - 1:00 pm
Webinar Online Event, OH United States

Electronic Health Records (EHR) arrived with a tidal wave of promise: implementing a system would make processes quicker and easier, thereby enhancing patient care while saving time and money. It was also expected to provide clear, real-time access to patient and payor information, increase productivity, and make hospital staffs’ lives simpler and more rewarding. Yet, implementing an EHR system hasn’t guaranteed increased productivity, physician satisfaction, or employee morale. Eliminating the waste from healthcare processes and understanding the needs of the…

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May 2014

Webinar: "How to Use Imaging in Translational Research" presented by ImageIQ

May 15, 2014 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Generating preclinical data that can actually inform and add value to a clinical trial can be tough and elusive without the right expertise. Imaging can generate a clinical trial data goldmine for regulatory approval and marketing success – IF it's appropriately planned for during the preclinical phase of product R&D. In this dynamic webinar, you will learn how to leverage your investment in preclinical imaging to improve clinical trial study design, enhance clinical data, strengthen product efficacy claims and save…

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June 2014

Webinar: Managing Readmissions – The Key to Impacting Your Bottom Line, presented by Health Care DataWorks and Fathom

June 18, 2014 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Nothing in our world is changing as quickly as healthcare. Every hospital and health care system is significantly impacted by readmission policies mandated by new regulations, and every facility must implement strategies to reduce the number of costly and unnecessary readmissions. Join Health Care DataWorks’ Chief Scientist, Dr. Jyoti Kamal, and learn how to better understand planned and unplanned readmissions, and identify patients at risk for readmission. During this 60-minute presentation you will discover how to decrease your readmission rates…

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August 2014

Webinar: Regulatory Submission Series Module 3, Verification of the Foundation

August 21, 2014 @ 12:00 pm - 1:30 pm
Webinar Online Event, OH United States

Join Soma Kalb, FDA’s Acting Director of the IDE Program at CDRH and Industry Expert, Ralph Hall, Counsel at Faegre Baker Daniels for our latest webinar: Verification of the Foundation. This serves as Module 3 of our Regulatory Submission Series. Now that the foundation is set for the submission of your new product it is time to verify the data that supports your 510(k). In this module you will gain insight to methods of collecting this important data. Understand how…

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September 2014

Webinar: What’s Hot & What’s Not in Oncology Licensing presented by ShareVault and BIO

September 18, 2014 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

This panel discussion will be a lively Q&A on what is exciting in cancer drug development and what is not popular in licensing, and why. Biotech and pharmaceutical consultant Linda Pullan will be joined by three panelists who are business development experts from a global pharmaceutical company, a leading academic cancer center, and a top business development consulting firm. The panelists will discuss theories of cancer, favorite targets and modalities, the impact of reimbursement, deal types, and more. If you…

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October 2014

Webinar: NCATS SBIR & STTR Funding to Advance Translational Research & Small Business Innovation

October 27, 2014 @ 12:00 pm - 1:30 pm
Webinar Online Event, OH United States

Are you interested in learning more about how you can leverage non-dilutive funding to advance your research and technology development? Through its SBIR and STTR funding opportunities, the National Center for Advancing Translational Sciences (NCATS) can help. Register today to join NCATS and BIO on October 27 for a webinar on how NCATS can support small businesses and technology transfer organizations as they develop and discover new therapies and diagnostics to help move bench research to clinical practice and commercialization.…

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Webinar: Aligning & Meeting Expectations Between Community Colleges & Life Sciences Companies

October 28, 2014 @ 3:30 pm - 4:30 pm
Webinar Online Event, OH United States + Google Map

Presented by MassBioEd, Massachusetts Community Colleges & Workforce Development Transformation Agenda (MCCWDTA) and the Coalition of State Bioscience Institutes (CSBI). We are working to better align the needs of industry with community college curriculum. Join us for this webinar for an overview of life sciences hiring trends, the impact of "up credentialing," how to build community college graduates' credibility, and the future of the "National Skill Movement." Presenters: Matt Sigelman, CEO, Burning Glass Technologies Lance Hartford, Executive Director, MassBioEd Foundation…

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February 2015

Webinar: ISO 11135 – Understanding the Changes and Ensuring a Balanced Approach (EO sterilization, EU Market)

February 2, 2015 @ 8:00 am - 9:00 am
Webinar Online Event, OH United States

ISO 11135:2014 (EO sterilization) was published July 2014 to replace ISO 11135-1:2007, 11135-2:2008 with a 36 month transition period. SynergyHealth presents a free webinar that will outline the changes in this revision and the actions that medical device manufacturers need to execute to ensure compliance by July 2017.  The webinar will take place at 8am EST and will have a European focus, however anyone is welcome to join as the content will have global impact. SynergyHealth will offer another webinar…

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Webinar: ISO 11135 – Understanding the Changes and Ensuring a Balanced Approach (EO sterilization, US Market)

February 11, 2015 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

ISO 11135:2014 (EO sterilization) was published July 2014 to replace ISO 11135-1:2007, 11135-2:2008 with a 36 month transition period. SynergyHealth presents a free webinar that will outline the changes in this revision and the actions that medical device manufacturers need to execute to ensure compliance by July 2017. The webinar will take place at 1pm EST and will have a US market focus. SynergyHealth will offer another webinar on February 2nd that will have a EU market focus and anyone…

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Webinar: Brand Science 101

February 17, 2015 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

          Building a good technology brand is a science unto itself. It’s more than creating a visual that represents a business. Brand Science is the proper combination and calculation of numerous disciplines ranging from graphic design and public relations to web programming and advertising. The outcome is a strong corporate presence delivered with a succinct promise. Ultimately, customer perception and expectation leads the way. Join BioOhio and member company Offenberger & White, Inc. as we put a B2B life science…

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March 2015

Webinar: Securely Sharing Confidential Documents Using ShareVault

March 26, 2015 @ 2:00 pm - 2:30 pm
Webinar Online Event, OH United States

Because BioOhio is an affiliate of BIO, our members are eligible for select BIO Business Solutions savings programs, including secure data services offered by ShareVault. ShareVault offers secure, cloud-based document sharing solutions, also known as virtual data rooms, that are frequently used by organizations of all types to securely share highly confidential documents with outside parties.  In contrast to consumer-grade file sharing services, ShareVault allows organizations to easily share documents with third parties, while monitoring access and maintaining control. This webinar…

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April 2015

Webinar: How to securely and compliantly manage images and data in your clinical trial

April 8, 2015 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Imaging adds a layer of complexity to a clinical trial, with the potential to impact compliance, logistics, time, and costs. Although the use of imaging continues to grow because of the insight it can provide, it is often overlooked during trial operations because of the complexity and because it is often a secondary end point. All this could add up to potential problems with image data accuracy, audits and inefficiencies. Fortunately, there is a new technology that allows you to…

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June 2015

Webinar: Implementing Next Generation Sequencing for Forensic DNA Analysis

June 25, 2015 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Sponsored by Battelle and presented by Forensic magazine, this webinar will focus on new “Next-Generation Sequencing” (NGS) technology that promises to transform how future forensic DNA analysis will be performed. Before NGS can be applied as a routine method in forensic laboratories, several technical and policy milestones must be passed. What you'll learn: Why NGS is informative for phenotype and biogeographic ancestry What the important differences are between STR fragment size analysis and STR sequence analysis How to prepare DNA…

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July 2015

Webinar: Preparing for the Military Health Systems Research Symposium 2015

July 15, 2015 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

G2G Consulting presents an informative, free webinar:  Preparing for the Military Health Systems Research Symposium (MHSRS) 2015 The U.S. Military’s Premier Meeting for Funding, R&D Partnerships, and Collaborative Industry-Military Innovation This is a great opportunity for any company with technology applicable to the protection, healing, and/or rehabilitation of the American warfighter. The symposium will be held in Ft. Lauderdale, Florida from Monday, August 17 – Thursday, August 20. The MHSRS is the Department of Defense’s (DoD) premier scientific meeting and…

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Webinar: Essential Steps for Successful BioPharma Partnering presented by ShareVault

July 16, 2015 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Preparing to Partner? Learn from an Expert with This Webinar:   “Essential Steps for Successful BioPharma Partnering” July 16, 2015 11am-12pm PDT / 2pm-3pm EDT Successful BioPharma partnerships don't happen by accident. And negotiating an out-licensing deal can be a daunting task – especially since the company may also be progressing the clinical portfolio. This webinar will provide you perspectives on the major steps required for a successful transaction. Gautam Aggarwal, a partner with Triangle Insights Group, will walk you through the essential…

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August 2015

Webinar: Making the most of the Military Health Services Research Symposium

August 3, 2015 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

G2G Consulting is partnering with MichBio and BioOhio to present a free webinar to explain the upcoming Annual Military Medical Conference. The presentation will provide information on defense funding, medical priorities and this upcoming conference where you can network with key leaders and program managers. The Annual Military Medical Conference, the Military Health Services Research Symposium (MHSRS), is August 17-20 in Fort Lauderdale and provides a great opportunity for innovations applicable to the protection, healing, and/or rehabilitation of the American warfighter to…

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September 2015

Women In Bio Webinar: “Best Practices for Sharing IP Rights in the Life Sciences”

September 2, 2015 @ 11:00 am - 12:15 pm
Webinar Online Event, OH United States

Join Women in Bio for a panel of experienced professional women who will discuss best practices and potential pitfalls associated with sharing intellectual property (IP) rights. An IP strategy is crucial for a company driven by technological innovation. Our expert panel will share their thoughts on how to effectively share IP, analyze potential collaborations, avoid pitfalls, and maximize an invention’s ROI. This is a great opportunity to gain legal perspective and wisdom from industry leaders. About Julie Watson: Julie Watson…

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November 2015

Webinar: Achieve Regulatory and Commercial Success for Your First Biopharma Product

November 18, 2015 @ 12:00 pm - 1:30 pm
Webinar Online Event, OH United States

Whether this is your first product launch or just the latest of many, obtaining timely FDA approval and considering key commercialization factors early in the development cycle are imperative to the continued success of your business. This webcast will help you navigate the complex US regulatory approval process for new molecular entities and understand the roles of regulatory, clinical, nonclinical and CMC stakeholders, including a discussion of the success factors for appropriate FDA interactions. In this Regulatory Affairs Professionals Society…

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January 2016

Webcast: Securely Sharing Documents in the Bioscience Industry

January 20, 2016 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Securely Sharing Documents in the Bioscience Industry How secure are your most confidential documents? Please join Sharevault and BioOhio for a webcast to find out how bioscience organizations are using secure document sharing solutions to work with outside parties. Explore the risks and benefits of various solutions, and evaluate the reasons why many bioscience organizations have selected ShareVault to protect their intellectual property. This webcast will cover the following topics: The common file sharing tools and services in use today The…

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March 2016

BioOhio FDA Regulatory 101 Series – Webinar: Medical Mobile Apps

March 3, 2016 @ 11:30 am - 12:30 pm
Webinar Online Event, OH United States

BioOhio and Leadership Member Regulatory and Quality Solutions (R&Q) are excited to present an ongoing series of medical device “FDA Regulatory 101” events. These sessions will spotlight a variety of regulatory topics such as FDA warning letter response, risk management, usability engineering, as well as a broad overview of medical device regulation in the US, Canada, and the European Union. The 2016 series will include a webinar on March 3, and live events May 3 in Cincinnati, July 28 in Columbus, and October 27 in Akron. Complete…

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Webinar: Must-Know Finance Concepts for Life Sciences Valuations presented by ShareVault

March 3, 2016 @ 2:00 pm
Webinar Online Event, OH United States

This webinar presents an introduction to the key concepts and most common methodologies used to evaluate life sciences assets. If you are an entrepreneur who is, or will be, raising financing, licensing an asset or selling your company, a private investor who wants to estimate and negotiate start-up share value, or any other professional who is active in the investing sector, you'll benefit from this overview of the key concepts used in life sciences valuation discussions. Presenters:  Jeff Karan, Founder…

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Webinar: National Cancer Institute SBIR Development Center: Funding, mentoring, and networking assistance for next-generation cancer technologies

March 3, 2016 @ 2:00 pm - 4:00 pm
Webinar Online Event, OH United States

Are you interested in learning more about how you can leverage non-dilutive funding to advance your research and technology development? Through its SBIR and STTR funding opportunities, the National Cancer Institute (NCI) can help. The NCI’s SBIR Development Center program enables small businesses and researchers to pursue the innovation of next-generation cancer cure technologies. Offering funding, mentoring, networking assistance and more, SBIR increases small business participation and private-sector commercialization of novel technologies that can prevent, diagnose and treat cancer. Register…

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How to Maximize Business Wire to Increase ROI with Social Media

March 29, 2016 @ 2:00 pm - 2:30 pm
Webinar Online Event, OH United States

In this short, 30 minute webinar Business Wire’s Director of Social and Evolving Media, Serena Ehrlich will show you just why Business Wire is so important to today’s reporters, analysts, bloggers and consumers and how to build a news release that truly leads to an increase your overall program success.

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ShareVault Webinar: Selecting Suppliers to Help You Build Medical Devices

March 31, 2016 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

ShareVault presents a webinar to help medical device companies understand the best practices to tackle supplier issues, avoid risks, and meet regulatory expectations. Featuring speaker Maren Nelson of M Nelson Consulting.

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April 2016

Guidance for Good Supply Practices (GSPs) in Life Sciences

April 5, 2016 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

XavierHealth has led a team of FDA officials and pharmaceutical and medical device professionals from some of the largest companies worldwide to uncover root causes and develop the latest addition to the suite of GSPs - Good Supply Practices. Join experts from Core Risks Ltd., Xavier University, and JLT Specialty USA for a complimentary webinar to learn about the upcoming guidance and how a holistic and pragmatic approach offers the surest route to supply chain integrity. Understanding the paradigm shift discovered…

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New FinTech Funding Alternatives for Life Sciences Companies

April 21, 2016 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

In this webinar, Scott Jordan, CEO of S. Jordan Associates and Co-Founder of HealthiosXchange, will summarize the impact of FinTECH (Financial Technology) and Legislation (JOBS Act) on financing, licensing, and “exit” (IPOs) activity in the healthcare industry. Scott will highlight the various “Titles” of the JOBS Act and how companies can leverage it to advance their development programs including: Title II of the JOBS Act: Rule 506 © - General Solicitation Description: Title II allows general solicitation of investors online;…

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May 2016

How the NIA took Parkinson’s Research to the Cloud

May 26, 2016 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join life science and genomic industry leaders -- the Statistical Genetics Group Lead for the National Institute on Aging and the co-founder of Google Genomics -- and learn how researchers use the cloud to securely store, process, explore and share biological datasets. Presenters will describe the process of building a workflow to support a recent study that processed nearly 200 TB of data for 6,500 exomes in just 3.5 weeks, compared to months on local infrastructure. During this webinar you…

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June 2016

Gaining a Competitive Edge in Packaging Using Simulation and SimApps

June 2, 2016 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

The need to reduce development time and produce optimized products is necessary to remain competitive in the packaging market. By using Simulation and user-friendly SimApps as part of your process, you can reduce the number of tooling and testing iterations, saving on cost and time to market.

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More Than Code: How True Interoperability Powers Precision Medicine

June 8, 2016 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

For more than a decade, healthcare interoperability has been top-of-mind for IT leaders, practitioners, investigators and administrators. Billions of dollars have been spent enabling the capture and storage of data, with the end goal of using it to the benefit of patients. And yet, an estimated 80 percent of healthcare data remains unstructured, and therefore locked and inaccessible. And so, we wait. Big data stands ready to answer big questions in treatment and care, and in this era of precision…

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Sae Reporting Requirements In Germany And Austria

June 20, 2016 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

SAE reporting is always a very critical part of a Clinical Trial, and within the EU, differences between requirements by national Law between the EU Member States also appear. Andrea Offer, Medical Research Manager at NAMSA GmbH, Germany will speak about Medical Device Clinical Trials: SAE reporting requirements in Germany and Austria during this webinar presented by NAMSA

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NAMSA Webinar: FDA Biological Evaluation Guidance

June 21, 2016 @ 2:30 pm - 3:30 pm
Webinar Online Event, OH United States

On June 16, 2016 the FDA officially released the much anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff.” This guidance document discusses the following topics: Use of risk assessments for biocompatibility evaluations for a proposed medical device Use of ISO 10993-1 and the FDA-modified matrix (Attachment A) to determine the relevant biocompatibility endpoints…

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Regulatory Application of Standard for Exchange of Nonclinical Data (SEND)

June 23, 2016 @ 1:00 pm - 3:00 pm
Webinar Online Event, OH United States

SEND creates structured organization and terminology for nonclinical electronic data submissions to the FDA, increasing the consistency between submissions and allowing for concise communication between the FDA and sponsors.

This webinar will provide an overview of the SEND initiative, including important dates, helpful reference documents, suggestions for how and where to begin the implementation process and information as to how SEND datasets are submitted to regulatory authorities.

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July 2016

Crowdfunding Best Practices July 2016

July 13, 2016 @ 9:00 am - 11:00 am
Webinar Online Event, OH United States

Crowdfunding is rapidly gaining popularity as a strategy for entrepreneurs to get capital to further their business ideas. The recent regulations about equity crowdfunding that took effect May 16th have changed the way startups can raise capital. This has accelerated the growth of crowdfunding platforms that can raise larger amounts of capital in return for an equity investment.

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Webinar: Preparing for the 2016 Military Health Systems Research Symposium

July 13, 2016 @ 1:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join G2G, BioOhio and MichBio for an informative webinar on the U.S. military’s premier meeting for bio-industry funding, R&D partnerships, and collaborative innovation. It’s a great opportunity for any company with technology applicable to the protection, healing, and/or rehabilitation of the American warfighter. G2G, which has over a decade of experience working with the U.S Military Health Systems, will provide an overview of the symposium, including the agenda, format, and travel logistics. Additionally, G2G will offer strategic guidance on how to…

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Ensuring A Successful Collaboration Between Sponsors & CROs

July 27, 2016 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

For many medical device and pharmaceutical companies, outsourcing some or all aspects of their clinical study support is becoming more common. After years of product development, the clinical study is the last step in getting the product to the market and/or the most expensive phase of the product development life cycle. Choosing a CRO partner for your clinical study could make your clinical research work a resounding success, if done correctly, or a colossal failure, if not done well. From…

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August 2016

Career Conversation 12 – Raising Your Leadership Voice

August 2, 2016 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Every female leader needs to have an authentic, strong leadership voice to ensure success in any conversation. In this interactive session presented by the Healthcare Businesswoman's Association (HBA), you will take away actionable tips, tools and examples on how to develop, build and embrace your own vision and voice that will be the ignition to catapult your career.

Leadership comes in many forms and with a variety of voices. But to succeed, female business leaders must figure out how they want to communicate their vision and leadership approach. Finding and raising your leadership voice is just the beginning. Once you have effectively created your authentic voice, you will be able to use that style of communication, that way of communicating and engaging in difficult business relationships and situations to be a powerful influence, drive change and have positive impact.

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Non-Dilutive Government Funding for Bioscience & High-Tech Disrupters

August 8, 2016 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

G2G invites you to participate in a free webinar on how to access government funding with a focus on non-dilutive government funding for bioscience & high-tech disrupters. To join the webinar, click here or call 202-827-6334. About G2G G2G (Government to Growth Consulting) is a consulting firm specializing in assisting businesses and non-profit organizations. G2G provides comprehensive consultation in the fields of government affairs, economic development, grant writing, public relations, and event planning. G2G also has extensive experience in the areas of lobbying,…

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IDE Submissions – Navigating an Efficient Path to Full Approval

August 9, 2016 @ 2:00 pm - 3:30 pm
Webinar Online Event, OH United States

Obtaining full FDA approval of an Investigational Device Exemption (IDE) is a critical step in the process of obtaining practical clinical experience and gathering valuable clinical evidence with your medical device. During this webinar, presented by NAMSA, the FDA will share their perspectives on the pitfalls and opportunities associated with preparing an IDE submission and interacting with FDA before, during, and after the submission. The goal is to convey important observations and recommendations that will help you to understand how…

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Risk-Based Monitoring in Clinical Trials: A Cross-Functional Approach

August 17, 2016 @ 10:00 am - 11:00 pm
Webinar Online Event, OH United States

Risk-based monitoring (RBM) extends beyond the idea of simply reducing onsite monitoring by performing less than 100% source document verification. Rather, a comprehensive implementation of RBM can provide an adaptable, integrated approach to monitoring that focuses on identifying and addressing risks to patient safety and data quality. In this process, a risk assessment discussion takes place at the planning stage and options for tailoring monitoring methods and resources to address those risks.  During the initial stage of this webinar, presented by NAMSA,…

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Accessing Government Funding and Advocacy Opportunities

August 23, 2016 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

G2G invites you to participate in a free webinar on how to access government funding with a focus on accessing government funding and advocacy opportunities webinar. To join the webinar, click here or call 202-827-6334. About G2G G2G (Government to Growth Consulting) is a consulting firm specializing in assisting businesses and non-profit organizations. G2G provides comprehensive consultation in the fields of government affairs, economic development, grant writing, public relations, and event planning. G2G also has extensive experience in the areas of lobbying,…

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NAMSA Webinar: New FDA Guidance on Biological Evaluation Panel Discussion

August 31, 2016 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

On June 16, 2016 the FDA officially released the much-anticipated Guidance Document Titled: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” Guidance for Industry and Food and Drug Administration Staff. In response to the guidance release, NAMSA conducted an informational webinar on June 21st providing medical device manufacturers the first in-depth and interactive overview into this guidance. We highlighted important changes critical for manufacturers to know…

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September 2016

Webinar: Introduction to Polymer Joining

September 13, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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The Ohio State University Master of Applied Clinical and Preclinical Research (MACPR) Program Information Session (Webinar)

September 13, 2016 @ 7:30 pm - 8:30 pm
Webinar Online Event, OH United States

The Ohio State University is hosting an information session to learn more about and prepare for Spring 2017 admission to The Ohio State University, Master of Applied Clinical and Preclinical Research (MACPR) Program. This is a 100% online, asynchronous, interdisciplinary Master's degree created to train research team members in preclinical and clinical research. There are full- and part-time options, with 4 specializations offered in clinical research management, regulatory affairs, clinical pharmacology, and safety pharmacology. There is no cost for this…

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Webinar: Ultrasonic and Spin Welding

September 20, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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Webinar: Vibration and Hot Plate Welding

September 27, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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Intellectual Property Webinar

September 29, 2016 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

U.S. patents and trademark registrations may not protect your interests overseas.  As an exporter, you may risk losing control over your brands and technology because laws in the country to which you are exporting may not protect your rights and allow unauthorized third parties to register your name and sell your product as their own.  They could also copy the technology to make your product, leaving you with no legal recourse.  The same could happen if you import products that…

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October 2016

Webinar: Laser Welding

October 4, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States + Google Map

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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Webinar: Adhesive Bonding

October 11, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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Must-Know Finance Concepts for Life Sciences Valuations, a ShareVault Webinar

October 13, 2016 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

ShareVault presents “Must-Know Finance Concepts for Life Sciences Valuations Part 2:  A More Detailed Explanation of Concepts” Speakers:  John Selig & Jeff Karan, Managing Partners, Mavericks Capital This webinar is a continuation of the first webinar, entitled "Must-Know Finance Concepts for Life Sciences Valuations," and goes into more detail on the key concepts and most common methodologies used to evaluate life sciences assets. Questions answered in Part 2 include: Which asset valuation methodology is most used by big pharma to evaluate possible…

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Webinar: Testing and Evaluation Methods

October 18, 2016 @ 1:15 pm - 2:00 pm
Webinar Online Event, OH United States

EWI is offering the popular FREE Plastics Joining Webinar Series again this fall. The series includes six sessions. By registering once, you will have access to all six sessions:  Introduction to Polymer Joining, Ultrasonic and Spin Welding, Vibration and Hot Plate Welding, Laser Welding, Adhesive Bonding, and Testing & Evaluation Methods. If you have questions about the series, contact Miranda Marcus at mmarcus@ewi.org.

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November 2016

FDA Webinar – Final Guidance on Medical Device Reporting for Manufacturers

November 30, 2016 @ 1:00 pm - 2:30 pm
Webinar Online Event, OH United States

On Monday November 7, 2016, the FDA issued final guidance on Medical Device Reporting for Manufacturers. This guidance document is intended to assist medical device manufacturers meet applicable reporting and record-keeping requirements for certain device-related adverse events and malfunctions. There have been numerous changes to the medical device reporting requirements since the FD&C Act first described them and the Medical Device Reporting regulation became effective over 20 years ago. The FDA’s final guidance on medical device reporting for manufacturers updates…

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December 2016

Webinar: New Strategy to Identify Small Molecule Therapies: Usher III Syndrome Case Study

December 1, 2016 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Charles River, in coordination with Case Western Reserve University, present the webinar New Strategy to Identify Small Molecule Therapies: Usher III Syndrome Case Study. Characterized by progressive deafness, blindness and variable balance disorder, Usher syndrome type III (USH3) is caused by destabilizing mutations in the gene encoding the clarin-1 protein (CLRN1). This webinar details a successful new strategy to identify small molecule therapies to mitigate the hearing loss associated with these mutations, highlighting the promise of this discovery approach in the quest…

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Management Liability Exposures for Life Sciences Companies

December 14, 2016 @ 2:00 pm - 3:30 pm
Webinar Online Event, OH United States

Join BIO Business Solutions partner, Aon, as they provide an overview of the management liability exposures for life sciences companies. Topics will include Directors and Officers Liability, Securities Class Actions, Cyber Liability, and ERISA exposure trends.

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January 2017

Non-Immuno-Oncology and Immuno-Oncology Partnering and Development: What’s the Role of Non-IO in an IO World?

January 26, 2017 @ 11:00 am - 1:30 pm
Webinar Online Event, OH United States

In this live web panel, presented by ShareVault, the panelists will discuss the role of non-immuno-oncology treatments for cancer in a world where immuno-oncology is playing a greater role.  Biotech licensing and pharmaceutical business development consultant Linda Pullan will be joined by four panelists who are business development experts from global pharmaceutical companies, a leading academic cancer center, and a top business development consulting firm. Discussion Synopsis The clinical success of checkpoint inhibitors has made Immuno-Oncology an amazingly "hot" area…

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February 2017

Assessing Neurological Ion Channel Therapeutic and Liability Targets

February 16, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Ion channel modulation provides an opportunity for therapeutic intervention to treat neurological disorders. However, unintended interference also presents risk in disruption of normal CNS function and potential therapeutic liabilities. This webinar, presented by Charles River Laboratories, will explore neurological ion channel therapeutic and liability targets, featuring four subtypes of NMDA receptors. Charles River Labs will also discuss the rationale and options for assessment of therapeutic compounds on panels of CNS ion channels for evaluating their risk for CNS liabilities.

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Feeling Hoarse? Is Your Strep Testing Complete?

February 22, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join Quidel and guest speaker Blake W. Buchan, Ph.D., D(ABMM) as he examines the growing importance of testing for Streptococcus pyogenes and Streptococcus dysgalactiae. Why should you register now for this webinar? Hear a national thought leader discuss how new molecular methods for strep testing are helping shape patient care in the acute and physician office lab settings What will this webinar empower you to do? Identify how a more complete strep testing method can improve patient care Have your…

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A Risk-Based Approach to Your QMS Implementation Webinar

February 28, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Please join R&Q for a free Intelligence Series webinar: A Risk-Based Approach to Your QMS Implementation - ISO 13485:2016 and ISO 9001:2015. This webinar presented by Regulatory and Quality Solutions outlines how organizations should establish a risk-based approach as outlined in the requirements of ISO 13485:2016, and the changes associated with implementation of the new edition of ISO 13485. In this session, R&Q will establish a basic understanding of the application of the risk-based approach in your QMS process, the evidence…

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March 2017

Intellectual Property Webinar

March 1, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Did you know that foreign entities can steal your technology, register your trademark without authorization, and/or hack into your system to steal proprietary information? Learn how to protect your brand and technology with this important webinar presented by NEOTEC!

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Use Video Content to Connect with Consumers Webinar

March 3, 2017 @ 12:00 pm - 12:15 pm
Webinar Online Event, OH United States

On the next 15-Minute “Business Wire Experts” Webinar Series, learn all about Business Wire’s video news division and how they're using proprietary social media and release engagement data to create a weekly show covering top trending news stories. Discover the types of stories that are seeing the most social engagement and learn about exciting new sponsorship opportunities that can drive measurable results for your news. Watch an episode prior to the webinar to see our most recent content at www.BizWireTV.com.…

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Webinar: Designing an Effective Clinical Trial for FDA Submission

March 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA for its latest webinar on "Designing an Effective Clinical Trial for FDA Submission," in which they will discuss various aspects of designing and conducting clinical trials that lead to successful submissions to the Food & Drug Administration (FDA), including best practices for getting the most out of your communication with the FDA. The information provided during this webinar will be based on the experience of Richard Kotz, NAMSA's Senior Medical Research Scientist for Biostatistics, and former Statistical Reviewer…

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Webinar: ONC Interoperability in Action Day

March 20, 2017 @ 9:30 am - 5:00 pm
Webinar Online Event, OH United States

Join ONC for the inaugural Interoperability in Action Day highlighting many of the successful standards and technology progress advancing the exchange of health information over the past year. This webinar will feature ONC’s most recent challenge contest winners, updates from the High Impact Pilot and Standards Exploration Cooperative Agreement Recipients, and exciting developments in the field. The day will be broken into two sessions: the morning session will feature an update on the ONC App Challenges and the afternoon session…

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R&Q Intelligence Series: Medical Device Single Audit Program (MDSAP)

March 28, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Attend this webinar, presented by Regulatory and Quality Solutions, if you want to understand MDSAP inside and out and be sufficiently prepared for its implementation Having been on the receiving end of two MDSAP audits, special R&Q Intelligence Series guest Connie Hoy of Cynosure Inc. (recently acquired by Hologic) will describe her successful first-hand experiences and offer step-by-step practical advice on how to adequately prepare for MDSAP and be successful. Her recent real-world case studies provide the perfect examples of…

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Webinar: Bioskills and Its Role in Product Development

March 29, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Bioskills is an essential part of any medical device development program for the testing and verification of the intended use and performance of a medical device, IVD or regenerative medicine product. It also serves as a critical step for device manufacturers and health care professionals to facilitate cross-functional interaction and learning that leads to the efficient development of new and innovative medical technologies. Join NAMSA for its upcoming webinar, “Bioskills and Its Role in Product Development,” and learn how the use…

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Webinar: “Microbiome: Hope or Hype”

March 29, 2017 @ 11:00 am - 12:15 pm
Webinar Online Event, OH United States

This ShareVault-sponsored web panel discussion with leaders in the microbiome research and development space will look at whether future advances in deciphering this paradigm can provide hope and revolutionize the healthcare industry and help innovate new ways to control disease and human growth, or whether the hype will unlock a Pandora’s Box of issues, which we understand very little about now. The panelists will uncover some of these truths and discuss where this new field of R&D is headed.  Here…

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April 2017

Webinar: The Benefits of Utilizing a Contract FCE in Clinical Trials

April 11, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join NAMSA for a joint webinar with MassMedic where we will discuss how medical device organizations can utilize contract Field Clinical Engineers (FCEs) to achieve efficiencies throughout the various stages of a clinical trial. Attendees can expect to better understand how FCEs can function as key team members through on-site clinical and technical support, and provide continuous oversight, education, protocol review and clarification for sponsors. This webinar will be presented by NAMSA's Paul Budny, RN, CCRA, CCRP; Field Clinical Engineer.

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Webinar: Learn the 5 key steps to successful Linkedin Marketing presented by ActionCoach

April 12, 2017 @ 11:30 am - 12:00 pm
Webinar Online Event, OH United States

Learn the 5 key steps to successful Linkedin Marketing:  1. Profiling 2. Positioning 3. Prospecting 4. Connecting 5. Messaging During this information packed 30 minute webinar, you will learn… A fresh new approach to Linkedin networking that is easy to implement, using less than an hour a day, to fill your calendar with potential prospects. A simple strategy that quickly reduces the amount of time and money you spend prospecting for new leads every month. 5 proven ways you can increase…

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Webinar: Leveraging FDA’s Expedited Programs Now and in the Future

April 12, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

As you know, FDA is committed to advancing the development of therapies that treat serious conditions and rare diseases. As part of this commitment, FDA offers expedited programs for biopharmaceutical companies to reduce development and review timelines for new drugs and biologics that address unmet medical needs. In this webinar, Cardinal Health regulatory experts will examine FDA’s four expedited programs—fast track designation, breakthrough therapy designation, accelerated approval pathway and priority review designation—and their impact on recently approved products indicated for…

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Webinar: Flu Season Review- Using Modern Technology to Monitor and Diagnose Flu

April 13, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Getting swept up in the flu season can feel like a whirlwind! Take a moment to step back with us and hear what experts have to say about the spread of influenza during the 2016-2017 season. Join Dr. John Tamerius on April 13th at 1:00 p.m. as he discusses highlights, surprises, and takeaways using the power of data visualization to tell the story of this year's flu season. Are you interested in learning more about: Using data to understand the…

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Webinar: Introducing a National Roadmap for the Future of Materials Joining and Forming Technologies

April 18, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

EWI recently developed a national roadmap on materials joining and forming technologies in a two-year project funded by the National Institute for Standards and Technology (NIST). The plan presents a national perspective on the current status of these important operations in manufacturing, and is believed to be the most comprehensive industry review ever completed in North America. This webinar will review the cross-industry canvassing methods employed in developing the road map, discuss the key needs identified by industry, and prioritize…

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Webinar: Combine your media database & your newswire to maximize your PR succes

April 21, 2017 @ 12:00 pm - 12:15 pm
Webinar Online Event, OH United States

In Business Wire's 15 Minute Experts webinar series, we share a wide range of tips and best practices designed specifically to increase the impact and ROI of your communications programming. You will come away with useful tips that you can use immediately to get even better results (ROI) for your clients. Business Wire’s next 15 Minute Experts webinar features Michele Putman, vice president of North American Markets at Agility PR Solutions -- a media database, monitoring and analytics provider. Learn…

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Webinar: EU MDR- Assessing the impact and next steps.

April 25, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join the next R&Q Intelligence Series webinar: EU MDR: Assessing the impact and next steps. The presentation slides and webinar recording will be made available to all registrants. Know the essential EU MDR requirements. The upcoming EU MDR changes are significant, potentially impacting your device classification and the need for clinical data. Considering the overall timeline – including ISO 13485:2016 (March 2019) and MDSAP (if selling in Canada; Jan. 2019) – it will be difficult to get on notified bodies’…

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May 2017

Webinar: The Purpose & Value of Chemical Characterization & Biological Risk Assessment in Medical Device Development

May 23, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Medical device organizations that manufacture products that involve patient contact are almost always required to perform biological safety evaluations, per ISO 10993-1, to ensure end-user safety. On June 16, 2016, the U.S. Food & Drug Administration (FDA) further expanded – and clarified – how device manufacturers seeking U.S. market clearance should comply with this standard as it relates to the evaluation and testing of devices throughout the risk management process. Using a risk-based approach, the FDA guidance includes detailed recommendations…

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Webinar: Change Control: The Good, The Bad and The Things You Need to Know for an Effective Program

May 23, 2017 @ 1:00 pm - 2:30 pm
Webinar Online Event, OH United States

This webinar, presented by ComplianceIQ, will help provide a template against which attendees can compare their own change control program, get insight into items to add to their procedures based on deficiencies cited by regulators or items to include when trying to start a change control program for the first time. About ComplianceIQ ComplianceIQ is an educational and learning portal devoted to advancing quality learning through seminars, workshops, conferences and online trainings (webinars & webcasts). They specialize in the creation…

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R&Q Intelligence Series Webinar

May 23, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Clinical evaluation requirements have been changing, with the latest impact coming from MEDDEV 2.7.1 Rev 4. Preparing for and meeting these requirements is important because the grace period offered by some notified bodies is ending and clinical evaluation reports (CERs) are being audited for compliance with the latest MEDDEV revision. Furthermore, the European Medical Devices Regulation (MDR) will impact CERs as well, once the regulation comes into force. It is important to be proactive to ensure CERs will meet your…

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Webinar: The EU IVD Regulation- Top 5 Changes for Medical Device Manufacturers to Consider

May 25, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The current EU IVD Directive (98/79/EC) has existed in Europe since 1998. However, as a result of continued scientific and technological advancements, this Directive is no longer 'fit for purpose.' Over time, there have been significant deviations from the Directive, forcing a departure from the document's original objectives and goals of maintaining the health and safety of IVD devices. The new In vitro Diagnostic Regulation (IVDR) was officially passed by the EU Parliament on April 4, 2017, which includes changes…

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Webinar: Zoster The Imposter: A Look at Varicella Zoster Virus and Herpes

May 31, 2017 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

In this webinar we look at the relationship in diagnosis of Varicella-zoster virus and Herpes simplex virus type 1 and 2. The review will uncover how treatment and patient counseling are affected based on diagnosis and how VZV as an STD is impacting public health. Join Paul A. Granato, Ph.D. on May 31 at 1:00 p.m. as he discusses the reasons and misconceptions around testing for HSV 1+2 in conjunction with VZV. Learn more about: Common HSV misconceptions How VZV is…

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June 2017

Webinar: Computational Simulation for Medical Devices

June 7, 2017 @ 10:00 am - 10:30 am
Webinar Online Event, OH United States

On June 7, AltaSim Technologies presents the webinar Computational Simulation for Medical Devices. Jeff Crompton and Kyle Koppenhoefer founded AltaSim Technologies 15 years ago to help elevate our customers’ technology through the use of advanced computational simulation. Over the last 15 years, we’ve had the opportunity to work with amazing companies from all over the world to develop simulations that impacted their technologies. Many of these companies have designed medical products based on our models, and these models have supported submissions to…

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Webinar – Clinical Studies in China: Understanding the Regulatory Framework & Trial Process

June 7, 2017 @ 10:00 am - 11:00 pm
Webinar Online Event, OH United States

Prior to 2014, medical device manufacturers wishing to introduce products to the Chinese marketplace were able to do so only if a subsequent approval was granted by the United States Food & Drug Administration (FDA) or the European Medicines Agency (EMA), per China Food & Drug Administration (CFDA) regulations. However, beginning in October of 2014, this approval process shifted significantly to require device manufacturers to conduct local clinical trials to demonstrate product efficacy and safety if no sufficient or existing data…

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Webinar: Clinical Trials in China- A Regulatory Framework and the Clinical Trial Process

June 7, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Please join us on June 7th at 10:00 AM EDT for latest webinar! Prior to 2014, medical device manufacturers wishing to introduce products to the Chinese marketplace were able to do so if a subsequent approval was granted by the United States Food & Drug Administration (FDA) or the European Medicines Agency (EMA), per China Food & Drug Administration (CFDA) regulations. However, beginning in October of 2014, this approval process shifted significantly requiring product manufacturers to conduct local clinical trials…

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MHSRS Webinar presented by G2G

June 28, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Background: In this webinar, you will learn about government opportunities for biosciences with a focus on the upcoming MHSRS Conference. The MHSRS (Military Health System Research Symposium Conference) is the largest military medical conference of the year. It is in Kissimmee, FL on August 27-30, 2017. Many DoD, DHA and USAMRMC leadership, program managers, clinicians, researchers, academia and industry attend and are eager to learn about medical innovations and ways to collaborate and bring them to market.Topics to be covered:…

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Webinar: Accessing Government Funding and Effective Advocacy for Nonprofits

June 29, 2017 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

A former Congressional staffer with decades of experience will provide insights on how government operates and how to run effective advocacy campaigns, secure government funding, and design your own strategic plan to shape the process through grassroots organizing, advocacy and PR in this webinar presented by G2G Consulting. The program will conclude with case studies and tips for success. Topics include: Budget Processes & Key Timelines Sources of Government Funding Decision-Makers for Funding and Policy Advocacy Tools & Case Studies Insider…

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July 2017

Webinar: The Value of Preclinical Studies from Concept to Commercialization

July 13, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join NAMSA on July 13 for this upcoming webinar. It is a common misconception within the medical device industry that preclinical studies only occur during the design phase of the Product Development Process (PDP). In reality, they have value at every stage of the development lifecycle – from concept efforts through product launch, and post-market support. Join us for our upcoming webinar as we discuss the critical role preclinical studies play throughout the PDP process. Presenter Mike Bravo (Director, Preclinical…

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Webinar: Understanding the FDA/CMS Parallel Review Process

July 18, 2017 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

NAMSA is excited to present a special joint webinar with the Medical Alley Association (MAA). Learn direct from medical device industry experts, Ken Skodacek (Policy Analyst), FDA Center for Devices and Radiological Health; and Seth Goldenberg (Director of Product Development Strategy), NAMSA, as they discuss the FDA/CMS Parallel Review Process. There are numerous stakeholders that must be considered when bringing a medical device to market. These include regulatory agencies, healthcare payers, healthcare providers, patients, and healthcare technology assessment organizations, just…

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Webinar: Understanding Medical Device Regulatory Pathways in China and Japan

July 20, 2017 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

The Countries of China and Japan each present their own unique set of challenges pertaining to medical device development. This is especially true for foreign manufacturers as they strive to stay abreast of the quickly changing device regulations and product approval processes in these sometimes tough-to-navigate geographies. Join NAMSA for a webinar with XTalks on July 20, 2017, as NAMSA regulatory experts Lei Yang, Medical Research Manager (China); and Kei Yoshikawa, Medical Research Manager (Japan), present information that will assist…

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