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July 2018

Webinar – FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder

July 25, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States + Google Map

On May 30, 2018, the FDA announced the launch of the Devices to Prevent and Treat Opioid Use Disorder Challenge to spur the development of medical devices, including digital health and diagnostic devices, to help combat the opioid crisis and to help prevent and treat Opioid Use Disorder—a serious health condition which can be a devastating outcome of opioid drug use. The FDA’s Center for Devices and Radiological Health will accept applications for this challenge from June 1 through September 30, 2018. Medical…

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2018 MHSRS Webinar for Biosciences, presented by G2G

July 31, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio partner G2G for their annual MHSRS webinar on July 31 at 12pm. Once you RSVP, you will receive the link to participate in the webinar. MHSRS Background: The MHSRS (Military Health System Research Symposium Conference) is the largest military medical conference of the year. It is in Kissimmee, FL on August 20-23, 2018. 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…

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August 2018

Webinar: EU MDR 2017/745: Optimizing Clinical Evaluation Reports Within the Medical Device Lifecycle

August 7, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

As there are less than two years remaining prior to the MDR enforcement, it is critical that EU device manufacturers prepare now for conformity by May 2020. In this webinar, NAMSA’s Manager of Medical Writing and Regulatory Services (EMEA), will examine the requirements listed in the MDR and MEDDEV 2.7/1 Rev 4, and discuss why device manufacturers shall not consider the CER a mandatory document for NBs or authorities, but rather as a crucial tool for a smooth transition for MDR and beyond.…

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Webinar: Making Youth Engagement Part of Your Workforce Strategy

August 9, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

We know you need workers today. What about in five years from now? Ten? Working with youth can help ensure you have a viable and diverse workforce for long-term success. The Alliance for Working Together Foundation (AWT) will share lessons learned over more than ten years of working to improve public perception and create awareness about opportunities in manufacturing. Our presenter will discuss why helping schools connect STEM to careers will help the manufacturing talent pipeline and offer avenues for…

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ShareVault Webinar: “The Nuts and Bolts of Selecting a CRO”

August 15, 2018 @ 2:00 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio partner ShareVault for the webinar: The Nuts and Bolts of Selecting a CRO on August 15 from 2-3pm. The clinical trial industry is highly regulated with a complex landscape. Contract Research Organizations (CROs) are a big part of any strategic product development life cycle. Sponsoring companies of new drugs, devices or biologics may outsource all or part of their clinical research. These service providers or vendors range from niche to full service capabilities, which a sponsor of a clinical…

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Webinar: Arbitration in Life Sciences Transaction Disputes

August 15, 2018 @ 4:00 pm - 5:00 pm
Webinar Online Event, OH United States

Presented by BioOhio member, Squire Patton Boggs Arbitration is rapidly becoming the preferred dispute resolution mechanism for the life sciences sector. There are numerous reasons for this focus. The most obvious is that increasingly, M&A transactions are cross-border (e.g., Takeda’s acquisition of Shire). The often complex and lengthy process involved in life science transactions can give rise to disputes at various stages. In this live one-hour webinar, senior counsel, Haig Oghigian, F.C.I.Arb., will discuss how to navigate these disputes from…

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Webinar: The New ISO 10993-1:2018 – What Now?

August 27, 2018 @ 10:30 am - 11:30 am
Webinar Online Event, OH United States

This webinar, presented by Don Pohl (Principal Product Development Strategist, NAMSA), will take a look at the major changes introduced within ISO 10993-1:2018, and also discuss how manufacturers can efficaciously prepare for implementation of these new requirements. Questions to be addressed include: What are the changes to the General Principles Applying to Biological Evaluation of Medical Devices? Is there clarification on when chemical characterization testing may or may not be needed? What are the categorization changes and how does that…

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September 2018

R&Q Webinar: Wait, what? That’s a combination product?

September 25, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on September 25 at 1pm. Is there a medical device hiding in your product portfolio? Combination products – defined in 21 CFR 3.2(e) – are often stealthy, and once you’ve discovered one, do you know what to do? This webinar will answer those questions and more. After defining what constitutes a combination product and examining other vital basics, we’ll share numerous case studies that shed light on how other companies of different sizes…

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Charles River Webinar: Integrated Approaches: Leveraging In Vitro and Ex Vivo Tools for Oncology Research

September 27, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join Charles River for the webinar Integrated Approaches: Leveraging In Vitro and Ex Vivo Tools for Oncology Research on September 27 at 11am. Overview Patient-derived xenograft (PDX) models are a valuable instrument in oncology. In this webinar, we will show how cell-based assays performed with low passage, PDX-derived material serve as cost- and time-effective tools to select appropriate models as well as conditions for in vivo efficacy studies. Join us to learn how an integrated approach based on PDX in vitro,…

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October 2018

G2G’s Post-MHSRS Conference Debrief Webinar for Biosciences

October 2, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

In July, G2G held its Annual MHSRS (Military Health System Research Symposium) Webinar for bioscience and high-tech companies to learn how to take full advantage of the largest military medical conference of the year to advance their medical innovations. After attending the MHSRS in August, G2G is hosting this webinar to share insights and key takeaways gleaned from the conference and talking with DoD, DHA, and USAMRMC leadership and program managers that will help companies align with military research priorities…

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Webinar: The Most Pressing Talent Needs of the Life Science Industry: Highlights from the 2018 CSBI National Workforce Trends Report

October 11, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

With the breakneck speed of new discoveries and shifting global and regulatory environments, the need for the right talent to drive innovation in the life science industry (which includes biotechnology, pharmaceuticals, digital health, medical devices, etc.) is a leading concern of life science employers. The 2018 CSBI Workforce Trends Report identifies the most pressing talent needs of the life science industry and the key trends that are driving talent acquisition. Please join the CSBI Chair and Workforce Committee Co-Chair for…

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NAMSA Webinar: EU MDR – General Safety & Performance Requirements for the Biocompatibility of Medical Devices

October 23, 2018 @ 11:00 am - 12:00 pm
Webinar Online Event, OH United States

Join BioOhio member NAMSA for the webinar EU MDR - General Safety & Performance Requirements for the Biocompatibility of Medical Devices. Are you preparing to upgrade your device technical documentation to meet the European Union’s (EU) Medical Device Regulation (MDR) 2017/745 General Safety and Performance Requirements? If so, this webinar will provide best practices and meaningful tips for manufacturers with devices sold under CE marks. NAMSA EMEA regulatory expert, Vincent Legay, will explain how the EU MDR requirements supersede current…

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R&Q Webinar: Understanding EU MDR and the Roadmap to Compliance

October 23, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on October 23 at 1pm. The EU MDR date of application is approaching faster than you might think. With changing schedules and increased scrutiny from the notified bodies, as well as an overwhelming amount of information out there, it can be difficult to understand the impact of the new regulations and determine where and when to start. Your technical files, design dossiers, quality system documents, clinical plans, labeling (including UDI), software, and more…

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November 2018

IVD Clinical Trials – Essential Components for Product Launch in 2019 & Beyond

November 6, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA for a webinar on 11/6 at 10am. Webinar Description: As in vitro diagnostic (IVD) markets and regulations change, it’s imperative to stay up-to-date on clinical trial components that are required to facilitate efficient, cost-effective market approvals. During this NAMSA-sponsored webinar, Kristin Jones, MS, CCRA (Principal Medical Research Manager), will discuss the essential mechanisms that must be addressed throughout IVD clinical studies regardless of product type or intended market launch territory. Highlighted will be: An overview of…

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Webinar: Ohio’s Medical Marijuana Law: How it Will Work and Workplace Implications

November 13, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Brian Higgins and Rich Moore from Frost Brown Todd will provide an overview of Ohio’s medical marijuana law and some related federal laws. They will then dive into employment-related issues posed by the law. Click here to register for the webinar.

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Cyber Security for Healthcare Businesses

November 13, 2018 @ 12:00 pm - 1:00 pm
Webinar Online Event, OH United States

Join BioOhio member Warwick for the webinar Cyber Security for Healthcare Businesses on November 13 at 12pm. 64% of organizations are using some form of managed services. Is your healthcare organization part of that percentage? If not, what are you waiting for? Having a fast, compliant and secure IT environment is essential for all businesses and organizations operating in the healthcare industry in order to comply with HIPAA and maintain the critical confidentiality of patient records. Click here to learn more…

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Webinar: Use Ohio TechNet’s Consortium to Build your Talent Pipeline

November 15, 2018 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join The Ohio Manufacturers' Association for the webinar Use Ohio TechNet’s Consortium to Build your Talent Pipeline on November 15 at 10 am. Ohio TechNet is a statewide consortium of 27 colleges/universities focused on accelerated training to meet the needs of Ohio’s manufacturers. This collaborative initiative launched with 11 colleges in 2014, training about 2,300 transitioning adults for careers in manufacturing. Participation of additional colleges and universities expands Ohio TechNet’s capacity to recruit and train your future workforce. Join us for this…

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R&Q Webinar: Economic Operators

November 27, 2018 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

Join BioOhio member R&Q for a webinar on November 27 at 1pm. The EU MDR extended the responsibilities of those who handle your information and product, and require you have new systems to interact with them throughout the process. In this webinar we will cover the requirements for authorized representatives, importers, and distributors. We'll also cover what you as the manufacturer need to do to ensure that these entities are prepared and ready for implementation. Key webinar takeaways: Your role…

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January 2019

R&Q Webinar: EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

January 16 @ 1:00 pm - 2:00 pm
Webinar Online Event, OH United States

BioOhio member R&Q is teaming up with Greenlight Guru for a webinar you won't want to miss on January 16th at 1pm ET! In May of 2017 the European Union’s Medical Device Regulation came into force and with that came a three year transition time which ends on May 26th, 2020. But despite the fact that we’re over 50% of the way through the transition, there continues to be anxiety and confusion surrounding how to interpret the EU MDR, what it means to…

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NAMSA Webinar: Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers

January 17 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member NAMSA For the webinar Understanding and Applying ISO 19227 Requirements for Orthopedics Manufacturers on January 17 at 10AM. Published in 2018, new medical device standard ISO 19227 builds upon previous French Standard NF S94-091 for orthopedics manufacturers. It not only provides guidelines in parallel to ISO 10993 for biological safety, but also further standardizes approaches for orthopedic implant cleaning. This NAMSA webinar, presented by Nicola Revellin, PhD (Sr. Medical Research Scientist—EU Biological Safety & Validation), will explore the impact…

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