Events

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

Risk Evaluation and Mitigation Strategies (REMS) Managing product risks and complying with FDAAA safety regulations The Carlton Hotel on Madison Avenue New York, NY

Jeff Wasserstein will be presenting “Using Social Media, Internet Search Ads, and Emerging Channels to Communicate with Consumers: Avoiding Mistakes and Triggers for Government Scrutiny” at the American Conference Institute conference on Advertising, eMarketing & Promotions for the Pharmaceutical Industry. Philadelphia, PA

Bob Dormer will be speaking at the Florida Medical Device Symposium Sheraton Inn & Suites Westshore Tampa Airport Tampa, Florida

Jeff Shapiro will be speaking at the RAPS DC/Baltimore Chapter Current Developments on the 510(k) Process RAPS Training Center Rockville, MD 5:30 to 8 pm

Jeff Gibbs will presenting New Product Approval Requirements at the FDA. Diagnostic Marketing Association’s Annual Conference Philadelphia, PA

Ricardo Carvajal speaking on “The FDA’s Direction and Management’s Responsibility in Food Safety” at 114th International Association of Operative Millers Conference & Expo.

Jeff Gibbs will be presenting “Regulation and Dessemination of Off-Label Information” at ACI’s FDA Boot Camp. Millennium Broadway Hotel New York, New York

Kurt Karst will be conducting an audio conference on “Navigating the Orphan Drug Designation Process, and the Benefits of Obtaining Designation” For Thompson Interactive 1:00 pm ET Duration: 90 minutes

Josephine Torrente will be speaking at Howard L. Reed Conference Massachusetts College of Pharmacy and Health Sciences Gillette Stadium One Patriot Place Foxborough, MA 02035

Kurt Karst presenting at the CBI West Coast Forum on Early Access Programs (EAP). His topic is “Understand and Navigate the Legal Landscape for Early Access Programs” San Francisco, CA

Dave Clissold will be speaking at the FDLI Introduction to Medical Device Law and Regulation conference. The Madison Hotel Washington, DC

Dave Clissold presenting GLG Webinar on “New Faces, New Outcomes? Inside the FDA Drug Approval Process.”

Ricardo Carvajal speaking on “FDA Under the Obama Administration” at the North American Millers’ Association 2010 Division Meeting.

Park Hyatt Washington Hotel Washington, DC

Kurt Karst will be speaking at the Biotech & Pharmaceutical Patenting conference. Hilton Munich Park Munich, Germany

Josephine Torrente will be presenting a “Review of REMS Draft Guidance” at the FDLI Emerging Realities in REMS Planning and Execution conference. Park Hyatt Washington Hotel Washington, DC

Dave Clissold will be presenting a webinar on “Opioid Class REMS: What’s It All About?”

Ricardo Carvajal speaking on “Food Safety: Unintended Components/Contaminants of Food” at the FDLI Introduction to Food Law and Regulation Annual Conference.

Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation. …