2019 Medical Device Insights 6.26.19
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:
Axinn, 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.
More presenters to be announced soon!
Coffee, tea, and a light breakfast will be served. In addition to our roundtable discussion, we will allow plenty of time for networking!