Loading Events

Past Events

Events Search and Views Navigation

Event Views Navigation

May 2020

FDA Emergency Use Authorization (EUA) and EU MDR Article 59, processes, tips, and lessons learned

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

Join BioOhio member firm R&Q for an informative regulatory affairs webinar. FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for prevention and treatment of COVID-19 In response to the COVID-19 global pandemic, health authorities are taking the necessary steps to allow for greater access to and use of critical medical devices and PPE that are in short supply.  However, some manufacturers lack the  necessary regulatory approvals needed to make their medical devices/PPE available.…

Find out more »

BioEDU Webinar Series: The Business of Bioscience – Forecasting Digital Health Investment Trends in the Wake of COVID

May 28 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

The COVID-19 crisis has shaken every industry, but none more so than healthcare. There is a silver lining, however: There is more interest than ever in startups in the digital health sector. Take away insights from BioEnterprise’s digital health team and regional investment professionals that can strengthen your business as the world recovers from the pandemic. This is the third session in our four-part BioEDU Business of Bioscience series, which take place every Thursday at 9:00 a.m. and feature live…

Find out more »

Innovation in the New Normal, Virtual Roundtable from Nottingham Spirk

May 28 @ 10:00 am - 11:00 am
Webinar Online Event, OH United States

Join BioOhio member Nottingham Spirk for their second virtual roundtable event to hear how prominent innovation leaders believe business will be forever changed by the coronavirus pandemic. Nottingham Spirk is asking business leaders: what is "the new normal" in the innovation world post-pandemic? Speakers include Asad Khan of Kent Displays, Mark Fleming of Vita-Mix Corporation, and Courtney Bott of Medline. Visit the registration page for more details and speaker bios.

Find out more »

June 2020

Case Studies of MDD and MDR Audit Findings and Lessons Learned, an R&Q webinar

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

R&Q's March 2020 webinar focused on EU MDR audit findings. Feedback from that webinar indicated you wanted to see more case studies. We heard you loud and clear. This webinar scheduled for Tuesday, June 2nd, will be completely focused on specific case studies of audit findings and lessons learned from both recent MDD and MDR audits. R&Q is supporting many medical device companies with their transition from MDD to MDR. These companies span a wide range of clinical specialties, notified bodies,…

Find out more »

FDAnews webinar featuring R&Q’s Jon Gimbel, Ph.D. on June 2

June 2 @ 1:30 pm - 3:00 pm
Webinar Online Event, OH United States

Join BioOhio member firm R&Q for an informative regulatory affairs webinar. In this FDAnews webinar, R&Q's subject matter expert Jon Gimbel, Ph.D. presents Implementing Clinical and Performance Evaluation Reports for Your Medical Device: Best Practices for Getting them Right. He'll cover what you must know to meet EU-MDR’s and EU-IVDR’s requirements, how to understand clinical and performance evaluation reports, and how to proceed through these new expectations. Click here to register for this webinar.

Find out more »

Teleconference Town Hall with Ohio Lt. Governor Jon Husted

June 3 @ 10:30 am - 11:00 am
Teleconference Phone Event, OH United States

Lt. Governor Jon Husted, Wednesday 6/3 at 10:30am You are invited to join us for a Teleconference Town Hall with Ohio Lt. Governor Jon Husted, led by John F. Lewis Jr., President & CEO of BioOhio. Space is limited – click here to register! Lt. Gov. Husted will discuss the administration’s efforts to reopen Ohio’s economy safely, address BioOhio members’ concerns about the future of the industry, and cover work being done by InnovateOhio. Under the leadership of Lt. Gov. Husted,…

Find out more »

NAMSA Webinar: EU MDR Part 2: How to Approach Clinical Evidence Requirements with Clinical Management and Biostatistics

June 3 @ 11:00 am - 12:30 pm
Webinar Online Event, OH United States

Sponsors involved with medical device design and development in the EU have rapidly diverted efforts to projects enabling increased production of essential devices during the current COVID-19 Pandemic. Understandably, the medical device industry is unable to focus efforts towards the fast-approaching current date of application of Regulation (EU) 2017/745 on medical devices (MDR) of 26 May 2020. On 3 April 2020, the European Commission published the proposal, “Regulation of the European Parliament and of the Council: amending Regulation (EU) 2107/745 on medical devices as…

Find out more »

The State of Chronic Care: How a New Federal Rule will Increase Prescription Drug Costs for Patients A Policy Discussion for Advocates

June 3 @ 1:30 pm - 2:30 pm
Webinar Online Event, OH United States

Join the Chronic Care Policy Alliance for a webinar on Wednesday, June 3 at 1:30 PM EST / 10:30 AM PST, as we discuss how a federal policy change will leave many patients facing higher out-of-pocket costs for their prescription medications. The recently released 2021 Notice of Benefit and Payment Parameters (NBPP) allows private health insurers to exclude certain co-pay assistance programs, such as cards and coupons, from counting toward deductibles and out-of-pocket maximums. As a result, patients will no…

Find out more »

BioEDU Webinar Series: The Business of Bioscience – Raising Non-Dilutive Capital in a Stressed Economy

June 4 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

Though venture capital gets most of the spotlight when it comes to fundraising, life sciences entrepreneurs and researchers should not underestimate the opportunities in non-dilutive capital for their startups. There are a number of financing and government agencies with programs and funds set aside to help bioscience innovations find their footing. Learn more about how to identify the right ones, insights into how to increase your chances for success and challenges anticipated in the wake of the COVID crisis. This…

Find out more »

Venture Law Meetup Webinar: COVID-19: Considerations for Getting Back to the Office

June 5 @ 9:00 am - 10:00 am
Webinar Online Event, OH United States

Please join BioOhio member Squire Patton Boggs for their monthly Venture Law Meetup Webinar. Leah G. Brownlee will be joined by Matthew Cooper and Matt Secrist to discuss considerations for getting back to the office in the COVID-19 pandemic. Complete connection details will be included in the confirmation. This complimentary webinar 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.…

Find out more »
+ Export Events