Events

Bob Dormer is speaking on “Hatch-Waxman Basics: Abbreviated Applications, Patents and Exclusivities” at the FDLI Introduction to Drug Law and Regulation conference. Hilton East Brunswick Hotel New Brunswick, NJ

Frank Sasinowki is lecturing at Cornell University’s Sloan Program in Health Administration on “Drug Development and Health Care”. Ithaca, NY

Jeff Shapiro is speaking on “Review of Recent Compliance Issues” at the AdvaMed/MTLI Advertising and Promotion Workshop. Washington Marriott Metro Center Hotel Washington, DC

Frank Sasinowki, board member of the National Organization for Rare Disorders (“NORD”), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s (“CURED’s”) first research symposium on eosinophilic gastrointestinal disorders (“EGID”).

Jeff Gibbs is a Tutorial Instructor for “Personalized Medicine” session Panelist for “Regulatory, Ethical and Social Policy Issues in Personalized Medicine: Discovery to Clinic” session Panelist for “Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communications with the FDA” session at DIAs 7th Annual Conference Discovery through …

Jeff Shapiro will be speaking on “Fundamentals of FDA Regulatory Device Law” and on “Overview of Device Regulation” at ACI’s FDA Boot Camp Devices Edition. Chicago, IL

Jeff Shapiro is speaking at the Orthopedic Surgical Manufacturer’s Association Fall Meeting on “Advertising and Promotion”. Arlington, VA

Kurt Karst will be speaking on “Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations” at ACI’s Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs. The Carlton Hotel New York, NY

Kurt Karst is a co-speaker at ACI’s Maximizing Pharmaceutical Patent Lifecycles conference for the session: “Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns”

James Ellison is speaking on “Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure” at the ACI’s National Forum on Pharmaceutical Pricing Litigation. Carlton Hotel New York, NY

Anne Walsh is a moderator for the session on “Trends and Priorities in Enforcement: Updates from HHS OIG and DOJ Officials” at the FDLI Advertising and Promotion Conference. Capitol Hilton Hotel Washington, DC

Kurt Karst is a co-presenter for the session on “Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now” at the C5 EU Pharma Regulatory Law conference. Le Meridien Hotel, Brussels

Diane McColl is speaking on “Oversight/Governance: Over an Increasingly Complex Food-scape” at the USP Science and Standards Symposium: Functional Foods and Dietary Supplements-Global Opportunities and Challenges. Boston Renaissance Waterfront Boston, MA

Wes Siegner is speaking on “FDA Update – Enforcement 2012: Things You Need To Know” at the Eighth Annual Nutrition Law Symposium. Thanksgiving Point Gardens 3900 North Thanksgiving Way Lehi, UT

Ricardo Carvajal is a panel member for “Compliance Challenges” and “Enforcement Hot Topics ” at the The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West Coast Conference  Dietary Supplement Global Strategies. Disneyland Hotel at Disneyland Resort Anaheim, California

Katie Bond presenting “Truth Stranger Than Fiction: Recent Developments in Dietary Supplement Litigation, Regulation and Truth in Advertising” at the Eighth Annual Nutrition Law Symposium.

Jeff Gibbs is a panelist for the Round Table Discussion: “Best Practices in Working with FDA Reviewers to Secure Regulatory Approval” at the Clinical Affairs and Regulatory Approvals for Diagnostics Conference. Hilton Alexandria Mark Center Alexandria, VA

Kurt Karst will conducting the PLI webinar on “Are You Ready to Enter the U.S. Biosimilars Pathway?” 1:00 to 2:00 pm EST

Jeff Shapiro is conducting Thompson Interactive’s webinar on Changes to the FDA’s 510(k) Clearance Process Webinar 1:00 pm ET/12:00 pm CT/11:00 am MT/10:00 am PT Duration: 90 minutes

Ricardo Carvajal is speaking on “Phosphorous Labeling in the U.S. – Regulatory Considerations” at the Dietary Phosphorus Consensus Conference. Honolulu, HI

Kurt Karst will be speaking on “Orange Book Listings, De  Listings and Related Challenges” at the ACI Hatch-Waxman Boot Camp. San Diego, CA

Jeff Gibbs is a panelist for the “Legal Jeopardy from the Conduct of Clinical Trials” session at the DIA Annual Conference. Philadelphia, PA

Dara Katcher Levy is a panel member for the session on “Importing FDA Regulated Goods: Satisfying New Safety Requirements and Agency Compliance Expectations” at the ACI Import Compliance & Enforcement conference. DoubleTree Hotel Washington, DC

12:30 – 2:00 p.m. ET This webinar will feature HPM attorneys Doug Farquhar, John Fleder, and Anne Walsh, who bring the full perspective of experience in government enforcement, including a former Assistant U.S. Attorney, the former Director of DOJ’s Office of Consumer Litigation, and a former …

Jeff Shapiro is conducting a webinar on “Discovering the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance” 1:00 to 2:30 pm

Jeff Gibbs is a panel member for the session on “Hot Topics in Medical Device Regulation: 510(k) Process; Risk Management; Social Media” at the FDLI Medical Device Regulation and Litigation Conference. The Madison Hotel Washington, DC

Ricardo Carvajal is participating in a panel on “The Impact of the Food Safety Modernization Act on the Food Industry” at the ABA Section of Litigation Food & Supplements Second Annual Workshop. Sara Lee Corporation 3500 Lacey Rd Downers Grove, IL

Anne Marie Murphy speaking on “FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials” at the Clinical Trial Oversight Summit. Omni Parker House Boston 60 School Street Boston, MA

Jeff Shapiro is participating in the :”Interactive Session: How to Respond to 483s and Warning Letters” at the AdvaMed Medical Device Workshop on FDA Inspections, Warning Letters & CAPA. Sheraton Crystal City Crystal City, VA

Kurt Karst is speaking on “To 505(b)(2) or Not To 505(b)(2)  Jumping the Legal Hurdles for Inhaled Drug Products” at the Respiratory Drug Delivery conference. JW Marriott Desert Ridge Resort & Spa Phoenix, Arizona

Bob Dormer will be moderating the session on “Best Practices in Dealing with FDA Inspections: Before, During & After” at the Florida Medical Device Symposium. Hilton St. Petersburg Carillon Park St. Petersburg, FL

Dave Clissold is moderating the session on “Building a Comprehensive Nicotine Regulatory Policy” at FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, Washington, DC

Jeff Shapiro is speaking as part of the FDA Center Director’s Roundtable panel at the FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC

Jeff Gibbs will be speaking on “Advertising and Promoting In Vitro Diagnostics” at the Association of Medical Diagnostics Manufacturers Annual Meeting. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road North Bethesda, MD

Anne Marie Murphy is speaking on “FDA Draft Guidance on the Movement toward a Risk-Based Approach” at CBI’s Risk-Based Approaches to Clinical Investigations. Philadelphia, Pennsylvania

Kurt Karst will be conducting the Thompson Interactive Webinar on “PDUFA V: Preparations for the New Fees and Performance Goals” 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes

12:30 to 2:00 p.m. ET Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision through multiple routes. The appeal processes in both CDER and CDRH offer numerous strategic and procedural …

Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Doubletree Suites Times Square New York, NY

Jennifer Newberger will be speaking on “Clinical Investigations” at FDLI’s Introduction to Medical Device Law and Regulation conference. Park Hyatt Washington Washington, DC

Jeff Shapiro will be speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s” and on “Advertising & Labeling” at the RAPS Medical Device Submission & Compliance Strategies for the US Market workshop. RAPS Training Facility Rockville, MD

Kurt Karst will be speaking on “Legal Considerations to Establish Biosimilarity and Therapeutic Interchangeability” at the University of Texas College of Pharmacy International Conference on Drug Development. He will also be participating in Roundtable Discussion. Austin, TX

Paul Hyman will be presenting “Regulatory, Legal and Political Processes in the Development of Food Labeling” at the National Kidney Foundation – The Public Health Impact of Phosphorus Homeostasis in Early CKD conference. Florida

John Gilbert will moderate the session on “The Scheduling Process: What You Need to Know” at the FDLI Controlled Substance Regulation conference. Hogan Lovells Washington, DC

Ricardo Carvajal is a moderator for the Labeling and Advertising session at FDLI’s Food Week conference. Park Hyatt Washington 24th & M Streets Washington, DC

Bob Dormer will be speaking on “Critical Issues Related to Regulation of Follow-on Biologics” at the University of Maryland, School of Pharmacy, Center on Drugs and Public Policy Invitational Conference.

Jeff Gibbs will be participating in the “Hands on Interactive Session: How to Respond to 483s and Warning Letter” at the AdvaMed conference on Avoiding A Warning Letter. Marriott Metro Center Washington, DC

Jeff Shaprio is speaking on “The Evolution of Expectations Over Time” at the AdvaMed conference: Avoiding A Warning Letter. Marriott Metro Center Washington, DC

John Fleder will be a panel member for the “Hot Topics in Criminal Litigation and Investigative Enforcement: 2011 Review, 2012 Preview” discussion at the FDLI Enforcement, Litigation and Compliance Conference. The Westin Washington, DC

Jeff Gibbs is speaking on “Understanding the Potential Impact of Changes to the FDA 510(k) System” at R&D Portfolio Management for Medical Devices conference. San Diego, CA

Ricardo Carvajal is speaking on “Navigating Today’s Labeling Requirements&And What’s Coming Up” at the IFT Food Policy Impact conference. Sheraton Crystal City Washington D.C.