Events

San Francisco Airport Marriott Burlingame, CA

Josephine Torrente will be presenting FDAAA Title IX: Effectively Dealing with Post-Marketing Safety Requirements and other Pharmacovigilance Concerns at the ACI conference: Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs The Union League Philadelphia, PA

Paul Hyman will be speaking at the International Regulatory Affairs Meeting. Maceio, Brazil

Ricardo Carvajal conducting webinar on Product Labeling and Process for the Personal Care Products Council. 12:30 – 2 pm EST

Kurt Karst will be presenting on “Understanding the Role of EMEA and FDA During Patient Compassionate Use and Expanded Access” at the CBI Inaugural Forum on Pre-Approval Expanded Access Programmes for the Bio/Pharmaceutical Industry. London, United Kingdom

Jeff Gibbs will be speaking at the FDLI Introduction to Medical Device Law and Regulation conference. L’Enfant Plaza Hotel Washington, DC

Bob Dormer will be participating in a panel at the University of Maryland School of Law Emerging Issues in Food and Drug Law: A National Conference for Lawyers, Policy-Makers, and Corporate Leaders

John Gilbert will be speaking at the BuzzeoPDMA’s 7th Annual Controlled Substances Conference Crystal Gateway Marriott Arlington, Virginia

Diane McColl chairing the session on “Main aspects of the substantive EU and US Food laws” at the US Food Law Conference. She is also presenting “Comments and overview of major differences in US law” at the conference. European Food Law Association US Food Law Conference Brussels, BELGIUM

Ricardo Carvajal speaking on “FDA’s Regulation of Nanotechnology: Current Controversies and Potential Impacts on Nanomedicine” at American Society for Nanomedicine Inaugural Conference Bolger Center Potomac, Maryland

Kurt Karst will be presenting “Differences of Opinion on NCEs – What are the Scope and Limits?” at CBI’s 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes Philadelphia, PA

Josephine Torrente will be presenting on Opioid REMS at the National Association of State Controlled Substances Authorities Annual Conference. Doubletree Hotel 1646 Front Street San Diego, California

Ricardo Carvajal will be speaking at NanoBiotech 2009 Troy, NY

Douglas Farquhar and James Ellison will be speaking at the FDLI Conference on Enforcement and Litigation. The Madison Hotel Washington, DC

Jeff Gibbs speaking at the Clinical Proteomic Technologies for Cancer (CPTC) 2009 Annual Meeting. Hyatt Regency Bethesda, MD

Kurt Karst will be presenting “Operating Compliantly and Legally during Pending Approval” at CBI’s 2nd Annual Forum on Early Access Programs Philadelphia, PA

Jeff Gibbs will be presenting a Webinar for Genetic Alliance on Genetic Testing In A Changing Regulatory Landscape. 11:00am – 12:00pm ET

Bob Dormer will be presenting 505(b)(2) & Related Applications: EU, US and Canada at the RAPS Annual Conference & Exhibition Pennsylvania Convention Center Philadelphia, PA

Ricardo Carvajal will be presenting “Spotlight on Nanotechology” at the ACI FDA Boot Camp. Omni Parker Hotel Boston, MA

Bob Dormer will be speaking at the American Conference Institute FDA Boot Camp. Omni Parker Hotel Boston, MA

Ricardo Carvajal will be conducting a webinar on Reportable Food Registry. This is part of FDLI’s webinar series on Issues and Implementation of the Food and Drug Administration Amendments Act of 2007 1:00 – 2:30 p.m. ET

Brian Donato will be presenting on “Legal Issues” at the OCRA Design Controls for Devices and Drugs meeting. Irvine Marriott 18000 Von Karman Avenue Irvine, CA

Dave Clissold and Ricardo Carvajal will be conducting a webinar on Family Smoking Prevention and Tobacco Control Act for Thompson Interactive. 1:00 – 2:30 pm

Brian Donato and Jeff Shapiro will be conducting the Virginia CLE webcast on Enforcement Powers and Practices of the U.S. Food and Drug Administration. 12:00 noon – 1:30 p.m.

Kurt Karst will be conducting the audio conference FDA Unapproved Drug Initiative – Determine, Prove and Ensure Compliance for Thompson Interactive 2:00 pm ET 90 minutes

Josephine Torrente will be speaking at FDLI Monoclonal Antibodies (MAbs) Conference. Sheppard, Mulllin, Richter & Hampton LLP Washington, DC

Jeff Shapiro moderating the FDLI audio conference on Human Tissue Regulation. 12:30 – 2:00 p.m. ET

Jim Phelps will be presenting Overview of WHO Review Process Related to Domestic and International Scheduling: The Need for Increased Transparency at the DIA 45th Annual Meeting on June 23rd. San Diego, CA

Paul Hyman will be a participant in the “Regulatory Roundtable: Overview of Federal Agencies and Implications for the Personal Care Products Industry Under the New Administration” on June 19th. Personal Care Products Council: 2009 Legal & Regulatory Conference The Fairmont Waterfront Vancouver, British Columbia

IRB Closures: Avoiding and Managing the Unexpected in Clinical Trials 12:30 – 2:00 p.m. ET

Bob Dormer will be presenting the “Generic Drug Regulatory Update” at the FDA/OCRA 12th Annual Educational Conference Irvine Marriott 18000 Von Karman Avenue Irvine, CA

Diane McColl will be participating in the panel discussion on the Expert Report at the Institute of Food Technologists Annual Meeting & Food Expo. Anaheim, CA

Ricardo Carvajal will be participating in the IFT Annual Meeting + Food Expo Anaheim, CA He will be an instructor on food labeling on June 5-6. He will also be presenting legal perspectives on GRAS determinations and the use of “natural” claims on June 8-9.

Introduction to Biotechnology Law and Regulation: A Program Focusing on Human Biologicals and Drugs The Embassy Suites Washington, D.C. Convention Center Hotel 900 Tenth Street, NW Washington, DC 20001

Ricardo Carvajal will be speaking at the FDA Fellows conference: Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry FDA 10903 New Hampshire Avenue Silver Spring, MD

Ricardo Carvajal will be presenting at the ACI Webinar on Nanotechnology Law, The Essential Guide to the Legal & Regulatory Aspects of Nanotechnology.

Josephine Torrente will be speaking at the Society for Clinical Trials 30th Annual Meeting Omni Hotel, CNN Center Atlanta, GA

Josephine Torrente will be speaking at the RADARS System Annual Scientific Meeting Bethesda, Maryland

Jeff Gibbs will be chairing the “Meet the CDRH Director” session at the 2009 FDLI Annual Conference. L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, DC 20024

Ricardo Carvajal will be a speaker for the FDLI webinar: What is Natural? 12:30 – 2:00 p.m. ET

Bob Dormer and Brian Donato will be speaking at Florida Medical Device Symposium, an annual event presented by Florida Medical Manufacturers’ Consortium, Inc. Tampa Marriott Waterside Hotel & Marina

John Gilbert will be presenting the “Legal Update” at the State and PDMA Regulatory Conference on “The Increasing Impact of Federal and State Requirements on Sampling and Prescription Drugs”. Arlington, VA

Ricardo Carvajal will be speaking on FDAAA – Prohibition on adding “drugs” to food, and advent of the Reportable Food Registry at the IFT FLDR mid-year meeting. Kirkpatrick & Lockhart Preston Gates Ellis LLP 1601 K Street, NW, Washington, DC 20006-1600

Ricardo Carvajal will be conducting the Nanotechnology Workshop at the FDA Boot Camp presented by ACI. Millennium Broadway Hotel New York, NY

New York, NY

Diane McColl will be presenting Is Your Food Ingredient a Drug? Regulatory Update on FDA’s Implementation of Section 331(ll) of the FDC Act at the IFT Wellness 09 conference Chicago, IL

John Fleder and Kurt Karst will be conducting a webinar for FDA News. The Real Impact of Wyeth v. Levine: How to Survive in a Post-Preemption World 1:30 p.m. – 3:00 p.m. EDT

Hosted by the Clinical Device Group 12:00 p.m. – 1:30 p.m. Eastern

Dave Clissold will be speaking at the FDLI Introduction to Medical Device Law and Regulation Conference. The Embassy Suites DC Convention Center Hotel Washington, DC

Diane McColl will be speaking at the Update for the EAS Consulting Food Labeling Compliance Review Seminar and Update EAS Consulting Group – Training Facility 1940 Duke Street, Suite 200 Alexandria, VA