Events

BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs  Why Successful Cures Bring Challenges for Patients and …

Jeff Gibbs will be part of the panel on “Aligning The Regulators and Industry To Accelerate Personalized Medicine Benefits” at the Personalized Medicine World Conference. Silicon Valley, CA

Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel. Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administrations Office …

Doug Farquhar and John Fleder will be conducting the audio conference: Are Attorneys the FDA’s New Enforcement Target? 2:00 pm ET Duration: 60 minutes

Diane McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and …

Kurt Karst will be conducting a Pharmalot webinar on “Navigating The FDA Accelerated Approval Process”. 1:00 PM ET Duration: 1 Hour

Jeff Shapiro will be leading the RAPS webinar and simulcast on “Updates on the FDA 510(k) Clearance Process”

Ricardo Carvajal will be one of the speakers for the Personal Care Products Council Webinar: Product Labeling, Assignment Processes and Global Harmonization of INCI Names. 12:30PM to 2:00PM ET

Susan Matthees will be speaking on “Registration and Listing for Medical Devices” at the FDLI Introduction to Medical Device Law and Regulation conference. Westin South Coast Plaza Hotel Costa Mesa, CA

John Gilbert will speaking on “State and Federal Legal Update on Controlled Substances” at the 8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference. Crystal Gateway Marriott Arlington, VA

Dara Katcher Levy will be speaking on “Analyzing the Current Pharma Communication Landscape” at the Pharmaceutical Compliance: Off-Label Drug Promotion Conference. Philadelphia, PA

Dave Clissold will be presenting “Clinical Data Falsification” at the Fifth Annual FDA Inspections Summit. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852

United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring Frank Sasinowski for his contributions to UTC’s development of its REMODULIN (trepostinil) …

Wes Siegner will be speaking on Foods and Dietary Supplements Structure Function Claims and Scientific Substantiation    and Enforcement and Compliance: Regulatory Compliance for Food, Dietary Supplement and Medical Food Companies at the RAPS 2010 Conference San Jose McEnery Convention Center San Jose, CA

Jeff Gibbs will speaking on Gene Patents & Diagnostic Tests at the AIPLA Joint Biotechnology Committee/Special Committee on FDA Law Program for the Annual Fall AIPLA Meeting. Marriott Wardman Park Hotel 2660 Woodley Road, NW Washington, DC

Anne Marie Murphy is presenting “Understanding and Navigating Through the Legal Landscape of Early Access Programs” at CBI’s 3rd Annual Congress on Early Access Programs (EAPs). Philadelphia, PA

Kurt Karst will be presenting “FDA Forfeiture Provisions and Review of Strategic Developments” at the CBI Life Sciences Congress on Paragraph IV Disputes. Philadelphia , PA

Doug Farquhar is on the planning committee for FDLI’s Enforcement and Litigation Conference. The Westin Washington, DC

Ricardo Carvajal a breakout session on Food and Dietary Supplements at the FDLI Enforcement and Litigation Conference. The Westin Washington, DC

Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic. You can register for the free webinar here. (Please register by September 29th.) In criminal prosecutions of corporate executives, …

Dave Clissold will be presenting a Webinar on “Opioid Class REMS: What’s Next?” for the Drug Information Association. 11 am to 12:30 pm

Kurt Karst will be presenting “Nature of the Approval Process” at ACI’s FDA Boot Camp. Seaport Hotel Boston, MA

Paul Hyman will be presenting “Claim Substantiation” the Food, Drug, & Cosmetic Division of the American Society for Quality 21st West Coast Conference. Anaheim, CA

Jeff Gibbs will be presenting at the European Pharmaceutical Regulatory Law conference. London, England

Kurt Karst will be speaking on “FDA Update” at the Specialty Pharma Association fall conference. San Diego Marriott Hotel & Marina San Diego, CA

Kurt Karst will be participating in the panel discussion “As the Drug Patent Landscape Evolves, Strategic Challenges and Opportunities Develop” at the Rodman & Renshaw Global Investment Conference – 12th Annual Healthcare Conference. New York Palace Hotel New York, NY

Jeff Gibbs will be speaking on “FDA Regulation of Protein-Based Diagnostic Tests” at the Cambridge Healthtech Institute’s Accelerating Development & Advanceing Personalized Therapy Conference. Hyatt Regency Crystal City Arlington, VA

Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at the ACI Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions conference. Downtown Conference Center New York, NY

Jeff Gibbs will be moderating the FDLI Webinar on FDA’s (Emerging) Oversight of Laboratory – Developed Tests. 12:30 to 2:00 p.m. ET

Diane McColl will be presenting “Overview of regulation of food ingredients and dietary supplement ingredients in the United States” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois

Ricardo Carvajal will be presenting “Labeling Requirements and Implications for Foods Marketed in the U.S.” and “Food regulation: Evolutionary changes in revolutionary times” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois

Diane McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises existing monographs and their associated reference materials for food ingredients, as …

Frank Sasinowski has been elected by the the U.S. Pharmacopeial Convention (“USP”) as an At-Large Trustee of the USP Board of Trustees for the 2010-2015 cycle. The Board of Trustees will guide the activities of the USP for the next five years and makes …

Kurt Karst will be presenting “Update on Regulatory Protections Available to Extend Patent Lifecycles: Comparing and Contrasting Europe and US” at the C5 UK conference on Maximising Pharmaceutical Patent Life Cycles. London, UK

Bob Dormer will be speaking on “Overcoming Challenges to Marketing, Branding and Promotion of Biosimilars” at the ACI Follow-On Biologics conference. The Helmsley Park Lane Hotel New York, NY

Bob Dormer will be speaking at FDA-OCRA Educational Conference. Irvine Marriott Irvine, CA

Brian Donato will be speaking at FDA-OCRA Educational Conference. Irvine Marriott Irvine, CA

Wes Siegner will be a guest speaker at the University of Maryland School of Law’s Federal Regulation of Probiotics Meeting. Baltimore, MD

Jeff Gibbs will be presenting at DIA 46th Annual Meeting. Washington, DC

Dara Katcher Levy and Carrie S. Martin will be presenting a webinar on FDA proposed rule on DTC broadcast ads. Sponsored by FDA News.

Michelle Butler will be presenting “Federal Government Contracts and Pricing: FSS, VA, DOD and More” ACI: RX Drug Pricing Boot Camp May 25 – 26, 2010 Sheraton Fisherman’s Wharf San Francisco, CA

Jeff Shapiro will be presenting “Effectively Responding to Warning Letters and Protecting Your Company’s Interests”. ACI: FDA Enforcement Summit – Fortifying Regulatory and Compliance Practices in the New Era of Aggressive Enforcement The Union League Philadelphia, PA

Brian Donato will be speaking at the MAGI 2010 Clinical Research Conference. Sheraton Boston Hotel Boston, MA

Bob Dormer will be speaking at the Washington Legal Foundation media briefing on “An Approval Pathway for ‘Biosimilars’: What’s Next for FDA on Health Care Law Implementation?”

Dave Clissold and Nisha Shah will be conducting a webinar on Falsified Data in Clinical Trials – How to Determine What to Report to the FDA. Sponsored by FDA News. 1:30 p.m. to 3:00 p.m. EDT

Jeff Wasserstein will be speaking on social media at the CHPA Regulatory and Scientific Conference. Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Ave. Bethesda, Maryland 20814

Paul Hyman will be presenting “Emerging Technologies and Crossover Jurisdiction (Combination Products)” at the Personal Care Products Council Legal and Regulatory Conference. LaPlaya Beach & Golf Resort Naples, Florida

Kurt Karst will be speaking at the AIPLA Spring Meeting New York Marriott Marquis New York, NY

Kurt Karst will be presenting “Legal Perspective on Approval and Legal Challenge Process for Topically Active Generic Inhalers” at the Respiratory Drug Delivery Meeting Omni Orlando Resort Orlando, Florida

Jeff Wasserstein will be speaking at the breakout session on social media. FDLI Annual Conference Hilton Washington Hotel Washington, DC