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      Medical Device Insights in Hartford

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      June 26, 2019

      Wednesday   8:00 AM

      90 State House Square
      Hartford, Connecticut

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      Medical Device Insights

      As a medical device professional, you are well aware of the challenges involved in bringing a product to market. Join us for an enlightening discussion about the latest in industry regulation--and how you can avoid the most common pitfalls when developing, manufacturing, and marketing your product.  Our guests will include executives in the medical device industry as well as attorneys with insight into related legal issues. Presenters will include: Severine ZygmontPresidentOPM Biomedical Severine has extensive experience in the field of high performance thermoplastics as well as operations management, advanced manufacturing, business planning, and capital formation. She has held several positions at OPM, including Applications Engineer, Vice President of Operations and Finance, and Chief Operating Officer.  A pioneer in personalized medicine, OPM Biomedical became the only company to receive FDA clearance to manufacture 3D printed patient‐specific polymeric implants when it received 510(k) clearance for its cranial prostheses line for surgeons around the world. The Company now has two additional FDA clearances, and is an original equipment manufacturer (OEM) for maxillofacial implants as well as its first spinal implant line. OPM also provides contract manufacturing services to third parties for a broad range of 3D-printed biomedical implant applications.  Severine is a member of OPM’s Board of Directors and has been named one of the 7 Top Women in Manufacturing by CNNMoney. She has also been recognized as a Woman of Innovation by the Connecticut Technology Council, and she currently serves as the Chair of CTC's Board of Directors. She holds a master's degree in chemical engineering from French engineering school Ecole Nationale Supérieure des Industries Chimiques and a bachelor's degree in industrial engineering from French engineering school Ecole Nationale Supérieure en Génie des Systèmes Industriels Learn more about OPM Biomedical. Suchira GhoshCounselAxinn, Veltrop & Harkrider LLP Suchira's practice focuses on regulatory and patent issues unique to the pharmaceutical industry. She provides counseling and litigation services relating to FDA and patent matters. Suchira has litigated disputes involving various marketing exclusivities arising under FDA authorities. She provides counseling services related to FDA matters, such as citizen petitions, REMS, abuse-deterrent drugs, biosimilars, user fee statutes, 505(b)(2) applications, marketing exclusivity, Orange Book issues, labeling, bioequivalence, patent notice letters, and approvals of drugs, biological products, HCT/Ps, medical devices and tobacco products. While in law school, Suchira interned in the FDA's Office of Policy, where she worked on issues of drug counterfeiting, pedigrees and track-and-trace. Prior to law school, she worked in the pharmaceutical industry as a process engineer with Schering-Plough Research Institute's Sterile Pharmaceutical Product Development group where she was responsible for developing and optimizing manufacturing processes for new drugs, including injectables, inhalers and lyophilized products from laboratory to commercial scale and technology transfer. Learn more about Axinn Veltrop & Harkrider LLP. Coffee, tea, and a light breakfast will be served. In addition to our roundtable discussion, we will allow plenty of time for networking!

      Categories: Science

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