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.

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.

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.

Please join us for an industry-wide briefing to discuss the importance of SBIR/STTR programs and the status of Congressional reauthorization. On September 13, AdvaMed Accel, SMTA, BIO, and CSBA will co-host a webinar to discuss the success of SBIR/STTR programs, the next steps to reauthorization, and Federal agencies’ approach to a potential lapse in program authority.

The role of biostatistics during a clinical study is often underestimated and viewed merely as a black box of providing statistical inputs at the end of a trial. However, partnering early and often with a Biostatistician on the design of your IVD clinical trial can help avoid costly mistakes, such as inadequate data collection, inefficient data pipelining and data cleaning. Join NAMSA for this webinar as we examine these critical areas, provide insight on how to prevent unnecessary delays and walk through two real-world case studies.

MDMA’s Medical Technology Executive Forum will deliver key insights on regulatory, reimbursement and other issues facing our industry. BioOhio members can receive $100 off the non-MDMA-member registration rate. Contact BioOhio staff for your discount code.

Join NAMSA for this webinar as we discuss strategies to optimize your preclinical testing with an emphasis on complex Class II and Class III medical devices focused in the cardiovascular therapeutic area. Highlighted will be an overview of cardiovascular device conceptualization, prototype and iterative design, model selection and how to build a foolproof pivotal safety-testing plan.

Every regulatory group is in agreement. Cleaning begins at the point-of-use. So why is it so hard to maintain compliance with this very simple and well-known standard? In this webinar, Healthmark Clinical Education Specialist, Malinda Elammari, will attempt to show the how and why of point-of-use cleaning as well as the vital role it plays in patient safety. This presentation will also give strategies for maintaining compliance over the long term. SPD, OR, Endoscopy, & IP professionals, pay attention!

The Cell & Gene therapy market is poised to undergo significant growth over the next 2-5yrs growing from a $1B market in 2018 to a ~$9B market by 2025. However, we anticipate finding qualified talent will become a critical roadblock to bringing innovative new therapies to market. Kelly Science & Clinical, the 2nd largest Science staffing agency, is taking the lead to address this challenge head-on by hosting the second installment of (Ex)2: The Expert Exchange Series, Accelerating Cell & Gene Therapy Careers. We will bring together well-known industry experts along with our own experts to discuss the growing talent needs and share with candidates insights and job opportunities for them to ride this wave to accelerate their careers in cell & gene therapy.

The Association of Food and Drug Officials (AFDO) and the Regulatory Affairs Professionals Society (RAPS) have come together to support sharing, collaboration, and learning across the global healthcare products community. With a focus on fostering open discussions of the most pressing issues facing the industry, the AFDO/RAPS Healthcare Products Collaborative will carry on Xavier Heath’s legacy of delivering Pharmalink in 2022. At PharmaLink, we work to find solutions that will increase confidence in product quality throughout your products’ life cycle management and global supply chain. We do this by aligning with the strategic priorities of the FDA and industry – and by helping participants create network links to drive compliant innovations. The solutions might not be evident within our companies, or our industry, so we explore beyond our industry – beyond borders and beyond comfort zones.