Events

This morning seminar will highlight the key current regulatory issues that can help device companies achieve success. The conference will integrate the new developments that directly affect device companies: the new FDA Amendment Act, approvals of devices, post-market controls and safety reports, FDA …

Bob Dormer will be speaking at the New York State Bar Association Annual Meeting Marriott Marquis 1535 Broadway New York City, NY

Brian Donato is one of the faculty for the National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville.

Kurt Karst and Dara Katcher Levy will be conducting a teleconference on: FDA Amendments Act- New DTC User Fees and Potential Penalties 1:00 PM – 2:30 PM ET

Bob Dormer will be speaking at the FDLI Fundamentals of Food and Drug Law and Regulation Workshop. The Embassy Suites Washington, D.C. Convention Center Hotel Washington, D.C.

Brian Donato will be speaking on “Agency Enforcement Powers” for the USC regulatory science course on medical products and the law.

Dave Clissold will be a speaker at the FDLI conference: FDA Implementation of the New Law The Food and Drug Administration Amendments Act of 2007 L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, DC

ACI: Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements conference. The Westin New York at Times Square New York, NY Bob Dormer presenting: Making an Early Assessment of the Impact of Generics and Regulatory Matters on the Collaboration Protecting against authorized generics earlier in the agreement Anticipating what …

Dave Clissold speaking at FDLI conference

Kurt Karst will be a featured speaker for the Thompson Interactive audio conference on FDA “Revitalization” Legislation- Essential Changes You Must Know. 1:00 PM – 2:30 PM ET

ASQ: 18th FDC West Coast Conference New Dietary Supplement CGMP Final Rule Disney Paradise Pier Hotel Anaheim, CA Wes Siegner will be presenting.

CTFA Webinar: California Alert – Safe Cosmetics Act Potential Ingredient List Reviewed 12:30PM to 2:00PM EST Brian J. Donato will be conducting the Webinar. Click

Josephine Torrente presenting: Understanding the FDA Process for Expediting Drug Development at the 5th Annual Symposium of the Association of Research Professionals – Baltimore/Washington Chapter

Jeff Gibbs will be the session leader for the IVD / ASR session at the RAPS 2007 Annual Conference & Exhibition. Hynes Convention Center 900 Boylston Street Boston, MA 02115

Stoel Rives LLP and the Association of Corporate Counsel Mountain West Chapter third annual Nutritional Law Symposium Thanksgiving Point Golf Club Lehi, Utah Wes Siegner will be moderating the panel discussion: “AER Implementation: What Do I Do Now?”

Jeff Gibbs will be participating in the R&D Roundtable for the Genetic Alliance: Eyes on the Prize – Truth Telling about Genetic Testing Renaissance M Street Washington, DC

Jeff Gibbs will be facilitating the CDRH/Medical Device Breakout Session for the FDLI’s Conference on Advertising and Promotion for the Pharmaceutical, Veterinary Medicine, Biologics, and Medical Device Industries. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road North Bethesda, MD 20852

Diane McColl will be speaking on “Health-Related Claims in the U.S.” at the IFT Annual Meeting and Food Expo McCormick Place Chicago, IL

Crisis Management Program

Brian Donato will be speaking on Adhering to Domestic and International Guidelines, Improving Product Safety and Controlling Liability by Instituting Risk Management Strategies at the CBI Medical Device and Diagnostics Risk Management Summit. Washington, DC

Bob Dormer presenting Making an Early Assessment of the Impact of Generics and Regulatory Matters on the Collaboration at the ACI Conference Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements Allocating Risk, Responsibilities & Rewards in In-Licensing, Co-Development & Co-Promotion Deals InterContinental Mark Hopkins San Francisco, CA

12 to 1:30 pm

John Gilbert will be speaking at the 69th Annual Meeting of The College on Problems of Drug Dependence Quebec City, Canada

Josephine Torrente will be presenting The New Drug Approval Process: NDA Submission and Review at the FDLI Introduction to Drug Law & Regulation conference. The Washington Court Hotel 525 New Jersey Avenue, NW Washington, D.C. 20001

Jeff Gibbs, Marc Shapiro and Kirk Dobbins will be presenting at the North Carolina Medical Device Association Medical Tech Forum in Raleigh-Durham, NC. Recent Regulatory & Legislative Developements In FDA Device Regulation: What’s Changing?

Maximizing Pharmaceutical Patent Life Cycles The definitive Hatch-Waxman event for biopharmas, brand names and generics InterContinental Mark Hopkins Hotel San Francisco, CA Kirk Dobbins will be presenting:    New Pre-Commercialization Concerns for Small Molecules and Biologics Kurt Karst will be presenting:    Drugs and Biologics: The Nature of the Approval Process    Present Controversies and …

Brian Donato presenting at CFTA Webinar on FDA Inspections of OTC Drug & Cosmetic Facilities: Your Rights & Obligations 12:30PM to 2:00PM EST Click here for more information.

Bob Dormer will be conducting FDLI/CDRH In-House Training on an Introduction to Food and Drug Law Regulation; Understanding How the Government Regulates the Drug Industry. Rockville, MD

JW Marriott San Francisco San Francisco, CA Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information on off-label or nonapproved uses of drugs and biologics be disseminated? peer review articles v. ghost-writing MSLs v. sales reps What are …

Brian Donato will be speaking on Global Approaches to Risk Management at Congress Risk Management Program. This program is sponsored by FDA, AdvaMed and Virginia Tech, Bethesda, Maryland.

Josephine Torrente will be speaking at FDLI Workshop: Introduction to Biotechnology Law and Regulation Workshop Focusing on Human Biologicals and Drugs The Madison Hotel 1177 Fifteenth Street, NW Washington, D.C. 20005 (202) 862-1600

Christine Bump will be presenting at the Surface Mount Technology Association’s Medical Electronics Symposium Sheraton Hotel Minneapolis, MN

CTFA 2007 Legal & Regulatory Conference Mansion on Forsyth Park Savannah, Georgia Brian Donato presenting: Is There Such a Thing As a Functional Cosmetic?

Food Update 2007 – Food, Nutrition and Public Policy Amelia Island, GA April 21-24, 2007 Jeff Gibbs’ April 23rd presentation will be:      How Viable is the Business Opportunity? Mr. Gibbs will also be participating in the panel discussions.

Jeff Gibbs will be speaking at the Association of Medical Diagnostic Manufactures 34th Annual Meeting. Marriott Bethesda North Hotel and Conference Center 5701 Marinelli Road North Bethesda, MD 20852

FDA Inspections – A Year in Review Presented by BuzzeoPDMA and Hyman, Phelps & McNamara, P.C. John Gilbert and Kirk Dobbins will be speaking at this conference. Crystal Gateway Marriot Arlington, VA

Jeff Gibbs with be speaking on “A Look At IVD Regulation” at the PharmaMedDevice conference in Philadelphia, PA.

Brian Donato and Robert Dormer will be speaking at the upcoming RAPS 2007 Horizons Conference & Exhibition. The Palace Hotel 2 New Montgomery Street San Francisco, CA

American Conference Institute InterContinental The Barclay New York, NY Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information on off-label or nonapproved uses of drugs and biologics be disseminated? peer review articles v. ghost-writing MSLs v. sales …

Brian Donato will be speaking at the USC Regulatory Science Program on Business Ethics in the Medical Products Industry.

Doug Farquhar will be presenting at the FDLI 5th Annual FDLI Enforcement and Litigation Conference. Compliance Officers, Manufacturers of Unapproved Drugs and Devices, or Marketers? Who will be the next FDA target? The Madison Hotel 1177 Fifteenth Street, NW Washington, DC 20005 (202) 862-1600

Brian Donato is one of the faculty for the 26th Annual National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville. He will be teaching and demonstrating “Trial Tactics and Techniques”.

A. Wes Siegner, Jr. Speaking at FDA Functional Foods Public Hearing beginning at 9 a.m. in the Center for Food Safety and Applied Nutrition’s Harvey W. Wiley Auditorium in College Park, Maryland.

Anne Marie Murphy will be presenting at the FDLI & CDG e-conference    How to do Post-Approval Registry Studies for Medical Devices 11:00 am to 1:00pm, Central Standard Time

Jeff Gibbs will be presenting at the AHLA Conference: Life Sciences – Fundamentals of Health Law Palmer House Hilton Chicago, IL

Dara Katcher will be presenting: Import & Export Requirements & International Issues at the FDLI: Introduction to Drug Law & Regulation Understanding How the Government Regulates the Drug Industry November 6-7, 2006 The Washington Court Hotel Washington, D.C.

IFT/University of Massachusetts Symposium The Path Forward for Functional Foods: Exploring Scientific and Legal Solutions for Defining Efficacy Diane McColl presenting: Demonstrating Current System for Health Claim Efficacy – Examples, Problems and Potential Solutions

Brian Donato will be lecturing at the University of Southern California, School of Pharmacy for their Regulatory Science Course: Medical Products and the Law. Mr. Donato has been a guest lecturer for USC in the past. He will be covering agency enforcement powers.

Marriott Bethesda North Hotel and Conference Center North Bethesda, Maryland Robert A. Dormer will be a speaker at the conference.

The Westin Kierland Scottsdale, Arizona