FDA Law Blog: ACI’s 28th FDA Boot Camp

FDA Law Blog: ACI’s 28th FDA Boot Camp

HP&M Announces that Serra J. Schlanger has Joined the Firm as an Associate Posted: 02 Aug 2016 05:11 AM PDT Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Serra J. Schlanger has joined the firm as an Associate. Ms. Schlanger assists clients with FDA regulatory strategy, compliance matters, and enforcement issues.  She has specific expertise with regard to federal and state health care fraud and abuse laws and defends clients in connection with government investigations and other enforcement inquiries.  Ms. Schlanger also advises clients on legal and regulatory issues associated with state licensure and CLIA certification. Prior to joining the firm, Ms. Schlanger practiced in the health care and life sciences practice of a national law firm, where she provided regulatory and compliance counseling to a wide variety of health care providers, defended clients in government investigations, and advised clients on issues related to the Medicare and Medicaid programs. Before beginning her legal career, Ms. Schlanger worked in clinical administration at Memorial Sloan-Kettering Cancer Center in New York City as a liaison between physicians, patients, researchers, and administrators. Ms. Schlanger graduated from Vassar College with a Bachelor of Arts in Science, Technology, and Society. She was a Leadership Scholar at the University of Maryland School of Law and graduated cum laude with a certification in Health Care Law.  While at the University of Maryland, she was the Executive Editor of the Journal of Health Care Law & Policy and a member of the National Health Law Moot Court team.  Ms. Schlanger is admitted to practice law in the District of Columbia and Maryland.

ACI’s Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics and Animal Food Posted: 02 Aug 2016 06:42 AM PDT The American Conference Institute (“ACI”) will hold the Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food on September 13-15, 2016, in New York City at The Carlton Hotel.  This forum will help attendees make sense of the legal and regulatory animal health landscape as well as the nuances and differences between the animal health and human health landscapes. This unique, one of a kind event is designed for lawyers and regulatory executives who work for the animal health industry.  This conference will provide attendees with state of the union updates in addition to in-depth discussions to discuss some of the industry’s most perplexing challenges. Hyman, Phelps & McNamara, P.C.’s Joseph W. Cormier will present with a panel of experts and provide an essential, yet intense and extensive overview of the legal and regulatory landscape of animal medicines, therapeutics, food and feed. Dr. Cormier will also present in a session titled “From Glofish to Frankenfish: Understanding How the Approval of Transgenic Animals May Impact Animal and Human Food and Drugs.” FDA Law Blog is a conference media partner. As such, we can offer our readers a special 15% discount. The discount code is:P15-999-FDAB17.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.

ACI’s 28th FDA Boot Camp Posted: 02 Aug 2016 06:41 AM PDT The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 28th iteration, is slated to take place at the Omni Parker House in Boston, Massachusetts from September 22-23, 2016. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. This year’s FDA Boot Camp has been designed to not only provide attendees with the essential background in FDA regulatory law, but also to provide key sessions that show attendees how to apply the regulatory knowledge to situations encountered in real life. Highlights of this year’s program include the “Ripped from the Headlines” sessions that will update attendees on key developments in the FDA regulatory bar, and “The Marketing Pendulum Has Swung,” which will focus on case studies analyzing off-label civil and criminal enforcement activity. A stellar cast of presenters will share their knowledge and provide critical insights on a host of topics, including: The organization, jurisdiction, functions, and operations of FDA The essentials of the approval process for drugs, biologics, and devices, including: INDs, NDAs, BLAs, OTC Approval, 510(k) submissions, and the PMA process Clinical trials for drugs and biologics and the clearance process for devices The classification of devices and the concept of “risk-based” classification The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics Labeling in the drug and biologics approval process cGMPs and other manufacturing concerns relative to products liability Proactive adverse events monitoring and signal detection Recalls, product withdrawals, and FDA oversight authority Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, who is co-chairing the conference, will present with a panel of experts and provide an overview of the Hatch-Waxman Amendments and the Biologic Price Competition and Innovation Act (“BPCIA”).  Mr. Karst will also head one of the workshops new to the ACI FDA Boot Camp program. Titled “Hatch-Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute,” Mr. Karst will deconstruct, in a step-by-step manner, a complex exclusivity dispute, analyzing FDA’s and the disputing parties’ various (and sometimes evolving) positions on exclusivity.  Relevant court decisions will also be analyzed and their practical and future effects discussed.  After the exclusivity case analysis is completed, attendees will have the opportunity to construct their own exclusivity dispute by choosing from various base facts.  Once the case is constructed, Mr. Karst will lead attendees through the exclusivity analysis. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 15% discount. The discount code is:P10-999-FDAB17. You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.