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FDA and NAMSA Webinar: Reducing Regulatory Burden and Streamlining FDA Review Through ASCA Pilot Program Utilization

Online Event

Join NAMSA and the U.S. Food and Drug Administration (FDA) as we present this upcoming webinar on July 20, 2022, regarding the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program, a first-of-its-kind conformity assessment program created by the U.S. FDA. During this webinar, the FDA will highlight how the ASCA Pilot Program streamlines aspects of conformity assessments for medical device submissions, as well as what manufacturers can expect when they submit ASCA test results to the government agency.

PDA Midwest Ohio Networking Event

Home Bistro Cleveland, OH

It’s time to refresh your network by seeing old friends and making new connections with other Pharma professionals at the PDA Midwest Ohio Networking Event on July 20th, at Home Bistro in Little Italy – Cleveland, OH. While networking, take advantage of the first-class service at Home Bistro, while indulging in some delicious food and signature cocktails. Pricing is free for this event; however, limited space is available. So, register now to confirm your ticket!

Ohio HealthTech Summit

Online Event

Join us on July 28 for the inaugural Ohio HealthTech Summit brought to you by OhioX and University Hospitals Ventures. This virtual event will take a deep look at the latest technology trends and activities happening in Ohio’s rich healthcare innovation ecosystem. Topics range from digital and virtual health to emerging technologies like extended reality, AI, and blockchain. Learn how Ohio providers, corporations, entrepreneurs, and investors are partnering to deliver outstanding care to Ohio consumers and communities.

FDA QMSR, What do the proposed changes mean for industry?

Online Event

NAMSA and the Regulatory Affairs Professional Society (RAPS) will hold this webinar to bring awareness to the U.S. Food and Drug Administration’s (FDA) Quality System Regulation (QSR) proposed changes and what these may mean for the medical device industry and MedTech manufacturers as a whole.

Building and Sustaining Successful Employee Resource Groups

Cardinal Health 7000 Cardinal Place, Dublin

BioOhio proudly supports diversity and inclusion within the bioscience and healthcare industries. Join BioOhio, Cardinal Health, and Forge Biologics to learn what makes an Employee Resource Group successful, and connect with the community to build a vision for the future of biotech and healthcare. We invite you to join us for this opportunity to convene with people and companies who have created ERGs, and those thinking of starting them. Diversity, Equity & Inclusion teams at leading bioscience companies will help guide this important discussion. This event will conclude with a networking reception.

Safety First: Understanding your Everyday Equipment, Tools, and Ergonomics, a Healthmark webinar

Online Event

In healthcare, we often hear the phrase “patient focus” which is designed to make decisions with the patient’s safety in mind. But all too often we forget that within the workplace, we also need to consider the safety and well-being of our sterile processing professionals who are facing the risks and doing the real work. This presentation will focus on the dangers and risks we face on a daily basis in our departments as well as provide solutions for those dangers and risks.

Specialty Pharmacy Distribution & Market Access Webinar

Online Event

The U.S. healthcare market is in a continuous state of flux and uncertainty. Now more than ever, it’s imperative that pharmaceutical manufacturers partner with emerging vendors to overcome the unique market access challenges of rare disease and gene/cell therapies to avoid pitfalls and to drive a successful product launch. During this webinar, our experts will provide in-depth insights on commercialization strategy, distribution models and demonstrating therapeutic value of Rare Disease & Gene/Cell therapies for patients, payers, and providers. This event features member Michael Baldzicki, Chief Brand Officer, AscellaHealth.

August Founder’s Story – Teri Sirset and Lakshmi Dasi from DASI Simulations

Rev1 Ventures 1275 Kinnear Road, Columbus

On this edition of Founder's Story, Rev 1 Ventures will host a breakfast with DASI Simulations's team who performs advanced individualized computational predictive modeling powered by artificial intelligence and computer vision to better plan for improved patient outcomes and reduced costs associated with Structural Heart Disease.

Webinar: Chemical Characterization Best Practices – Assumptions of TTC and Exhaustive Extraction

Online Event

A dramatic shift in regulatory opinions has occurred within the last several years regarding the concepts of Extractables and Leachables (E&L) testing of medical devices, commonly known as Chemical Characterization. Much of that change was driven by the 2020 revision to ISO 10993-18. Join NAMSA for this webinar to learn more about the foundations behind Chemical Characterization and to examine best practices deriving from it.