Events

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.

Ricardo Carvajal is the co-instructor for IFT food labeling short course: Labeling Requirements and Implications for Foods Marketed in the U.S. Sheraton Crystal City Washington D.C.

Josephine Torrente is speaking at the Regulatory Issues For IP Professionals conference in the sessions: – Orphan Exclusivity – Regulatory Strategy and Appropriate Interaction with Authorities – The Regulatory Frameworks for Advanced Therapy Medicinal Products Harrington Hall Hotel, London

Jeff Gibbs is speaking on “Prepare your Clinical Trials for Compliance with New FDA Regulations on LDTs and IVDs” at Biomarker Applications For Improved Clinical Trial Outcomes. Hilton Boston Back Bay 40 Dalton Street Boston, MA

Diane McColl will be presenting “Routes to U.S. Market for Functional Ingredients in Foods, Medical Foods, and Dietary Supplements” at the Conference of the American College of Nutrition. Malcolm Forbes Conference Center of Morristown Memorial Morristown, NJ

Kurt Karst is conducting the Thompson Webinar “Navigating the Orphan Drug Designation Process: Benefits of Obtaining Designation”. 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes

Jeff Shapiro is speaking on “Recent Update of Compliance Issues” at the AdvaMed Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing conference. Four Points Sheraton Downtown Washington, DC

Josephine Torrente will be speaking on “Reading the Drug Safety Tea Leaves – Top Legal and Compliance Challenges that Lie Ahead” at the Fourth Annual Risk Management and Drug Safety Summit. National Press Club Washington, DC

Kurt Karst will be conducting the FDA News webinar “Marketed Unapproved Drugs”. 1:30 to 3 pm EST

Jeff Gibbs will be speaking on “The Basics: Understanding and Working with the FDA – Jurisdiction, Functions, Organization, and Operations” at the ACI’s FDA Boot Camp Device Edition conference. Sutton Place Hotel Chicago, IL

Diane McColl will be speaking on “The FDA Food Safety Modernization Act And What It Means For Importers” at the European Food Law Association Food Law Conference. Brussels, Belgium

Kurt Karst is speaking on “Generics in the US: A Regulatory Primer on Filing and Recent Actions” and in the Workshop on “Pay-to-Delay Agreements” at the RAPS Regulatory Convergence Conference. Indiana Convention Center Indianapolis, IN

Jeff Shapiro will be conducting the Thompson webinar: Combination Products – Classification, Regulations, and Guidances 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes

Josephine Torrente is a panel moderator for “Collaborating on an Agenda for the Future – A Dialogue to Address the Challenges in Orphan Product Development” at the National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC

Kurt Karst will be speaking at the Informa Inhalation Drug Development Conference London, UK

Frank Sasinowski is a panel member for “The Special Importance of Patient-Academic-Industry-Government Collaboration in Orphan Product Development” at the DIA & National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC

Kurt Karst will be presenting “REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies” at ACI’s 12th Annual Maximizing Pharmaceutical Patent Life Cycles conference. New York, NY

Ricardo Carvajal is speaking on “Food Safety Modernization Act Implementation Update” and “New Dietary Ingredients” at the ASQ Food, Drug, and Cosmetic Division’s 22nd West Coast Conference on Dietary Supplement Challenges: cGMPs, Analytical, FSMA, NDI, and More. Paradise Pier Hotel at Disneyland Resort Anaheim, CA

Wes Siegner is a panelist for the “NDI Guidance: Light or Darkness at the End of the Tunnel?” section of the Seventh Annual Nutrition Law Symposium. Thanksgiving Point Golf Club Lehi, UT

Roger Thies will be speaking on “FDA Update” at the Specialty Pharma Association Fall Conference. Marriott Marquis Hotel & Marina San Diego, CA

Wes Siegner speaking at Specialty Pharma Association Conference on “Overview of Claims and Marketing Strategies for Medical Foods, Foods for Special Dietary Use, and Dietary Supplements”. Marriott Marquis Hotel & Marina San Diego, CA

Kurt Karst will be speaking on “FDA Regulation of Generic Drugs” at the Informa Global Generic Strategy Summit. Kempinski Hotel Bristol Berlin, Germany

Anne Walsh will be a panelist on “Qui Tam (Whistle Blowers) and Fraud Claims – Current Strategies and Developments” at the Greater Philadelphia Alliance for Capital & Technologies Medtech Luncheon. Applebrook Country Club 100 Line Road Malvern, PA 19355

Katie Bond speaking on “How ‘Competent and Reliable’ is Your Scientific Evidence? Meeting the FTC’s Substantiation Standards for Health-Related Advertising” at the Colorado Bar Association Advertising Law.

Jeff Shapiro is speaking at the RAPS Webcast: Advertising, Promotion and Labeling – Marketing in a Regulated Environment. 11:00 am5:30 pm EST

On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued earlier this month.

Jeff Shapiro will be presenting “Introduction to the Combination Product Sector” at the Clinical and Regulatory Strategies for Combination Products Conference. Baltimore, MD

Kurt Karst will be speaking on “180-Day Exclusivity Forfeiture” at the FDLI Conference: Brands, Generics, and Hatch-Waxman-New Challenges; Unabated Controversy. The Westin City Center Washington, DC

Jef Shapiro is presenting an audio conference on the appeals processes available for medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. He will discuss practical tips and advice on how to resolve a dispute with …

Ricardo Carvajal will be speaking on “The Reportable Food Registry One Year Later: Best Practices for Reporting Events While Minimizing Exposure to Government Investigation or Private Litigation” at the ACI Food Safety Regulatory Compliance Summit. Chicago, IL

Dave Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed to benefit the public …

Ricardo Carvajal will be presenting at the IFT Annual Meeting. His topics include: Nutrition Labeling Requirements for FDA Nutrition Labeling Requirements Nutrient Content, Structure/Function and Health Claims Other Claims: Production, Processing, and Marketing Create and Evaluate Your Own Food Label The Legal Aspects of Food Allergen Labeling and Control

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

Josephine Torrente will be moderating a session titled “From Qualitative to Quantitative-Benefit Risk Models and Patient Perspectives” at the FDLI conference: Issues and Answers – Advancing Risk Evaluation and Mitigation Strategies and Benefit-Risk Management to the Next Level. The Westin City Center Washington, DC

Frank Sasinowski will be presenting at the NORD Partners in Progress celebration. Washington, DC

Kurt Karst will be speaking on “Mastering Regulatory Maneuvers Essential to PIV Litigation” at the ACI Paragraph IV Disputes Conference. New York City, NY

Bob Dormer will be speaking on “Compliance Strategies for the Medical Device Industry” at the Florida Medical Device Symposium. He is also on the Panel Discussion entitled “Current FDA Issues”. Hilton St. Petersburg Carillon Park St. Petersburg, FL

Jeff Shapiro speaking on “When a 510K or PMA Goes Off Track: What Are the Options for Appeal” at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting. Bethesda North Marriott Hotel and Conference Center Bethesda, MD

Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter has joined the Firm as a Regulatory Scientist. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness Research, Personalized Medicine, …

Kurt Karst will be speaking on “Disease Subsetting” at the World Orphan Drug Conference. Hilton Embassy Row Washington, DC

Jeff Wasserstein will be speaking on “Our Hearts are a-Twitter: Social Media and Therapeutic Products” at the 54th Annual FDLI Conference. Ronald Reagan Building International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC

Jeff Shapiro will be speaking on “Communicating Effectively with the FDA and Collaborating with the Agency When Implementing a Recall” at ACI’s Drug and Device Product Recalls Summit. The Union League Philadelphia, PA

Kurt Karst will be conducting the Thompson audio conference: Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation. 2:00pm to 3:30 pm

Jeff Wasserstein will be speaking on “Fear Not Pharma: Revolutionizing Your Marketing Strategies to Adapt to Social Media Platforms” at the ACI 9th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry conference. The Union League Philadelphia, PA

Josephine Torrente will be speaking on “Expediting Cancer Therapies” at the conference on Regulating the Drug Treatment of Cancer. Sponsored by the University of Washington Schools of Law, Medicine, Public Health & Pharmacy. Room 138 William H. Gates Hall University of Washington Law School Seattle, Washington

Jeff Gibbs moderating the CDRH Breakout Session of the DIA “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” Washington Marriott Wardman Park Washington, DC

Ricardo Carvajal will be a co-moderator for a session on the impact of the Food Safety Modernization Act at the ABA’s First Annual Workshop on Food and Supplements, Section of Ligation, Food and Supplements Subcommittee of the Products Liability Committee. The Coca-Cola Company 1 Coca Cola Plaza Atlanta, …