Pete Rutkowski

Additional information available here.

Additional information available here.

Objective and Area of Discussion: The 24th Adler Symposium will focus on three major themes: The microbiome; glucose, insulin, and brain metabolism; and neuroinflammation. Recent data indicate that the microbiome not only influences the gastrointestinal system, but that it can have a profound impact and interaction …

FEBRUARY 3-4, 2015 | SONESTA HOTEL | PHILADELPHIA, PA CBI’s Expanded Access Programs is a tailored, two-day meeting for those considering or currently working on the design and execution of a variety of access management programs, including but not limited to: Expanded Access Programs, Early Access …

An interview with Frank Sasinowski was published in a Neurological Rare Disease Special Report, a Supplement to Neurology Reviews. In the interview, Mr. Sasinowski discusses how FDA has consistently exercised reasonable, appropriate, science-based flexibility in its review and approval of rare disease therapies. If you have …

The Carlton Hotel, New York, NY The FDA is currently working on a draft guidance for a new regulatory framework for the cosmetics industry. However, much to the dismay of cosmetic and personal care products manufacturers, the Agency announced last year, that it would not accept …

Renaissance Downtown Hotel 999 9th St NW Washington, DC 20001 Program Description Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the changing trends in enforcement, litigation, and compliance. Across all agency-regulated products, the Food and Drug Administration (FDA) is …

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Fairmont Scottsdale Princess 7575 East Princess Drive Scottsdale, Arizona 85255 (480) 585-4848 The Specialty Pharma Cost Management & Medication Adherence conference will feature tools health plans can implement to successfully manage the exorbitant cost of specialty pharmaceuticals and strategies for improving member’s adherence and overall compliance. …

Renaissance Dupont Circle Hotel 1143 New Hampshire Avenue, NW Washington, DC 20037 • John Fleder will be presenting “FTC and the Regulation of Medical Devices, 11:15 am – Noon on November 18th. • Jeff Shapiro will be presenting “Review of Recent Compliance Issues,” 2:00 pm – 2:45 …

RDD Asia 2014 was a two day meeting that seeked to link Asian regulators, industrial and academic scientists, clinicians and business professionals with their international counterparts with the goal of advancing inhaled drug therapy worldwide. RDD Asia, like its predecessors in the United States and Europe …

Genzyme Center Corporate Headquarters 500 Kendall Street Cambridge, MA 02142 Join us for the 1st ever MassBio Patient Advocacy Summit. We’ll bring industry leaders together with patient advocates and other stakeholders to examine ways in which life sciences companies can more fully incorporate the patient voice …

On July 31, the Food and Drug Administration (FDA) notified Congress that it intended to issue two draft guidances regulating laboratory-developed tests (LDTs). While the Energy & Commerce Committee House Subcommittee on Health did hold a hearing on September 9, Congress took no steps to …

Hyatt Regency Indian Wells Resort & Spa 44600 Indian Wells Lane Indian Wells, California, USA, 92210

Hyderabad International Convention Centre Novotel & HICC Complex (Near Hitec City) P.O Bag 1101 Cyberabad Post Office Hyderabad – 500 081 OMICS Group International contributes to the scientific community through its Open Access Initiative and OMICS Group Conferences. OMICS Group hosts over 400 leading-edge peer reviewed Open …

HPM’s James Valentine will be facilitating a session on October 30, 1-2:30 p.m., Session 7: Patient Engagement: How Can We Improve? Washington Marriott Wardman Park 2660 Woodley Road, NW Washington, DC 20008

This one-day conference focuses on significant developments in the federal regulation of tobacco products. The program brings together government, industry and public interest experts to provide updates on the latest developments in FDA tobacco product regulation. With guidance from expert speakers, participants will review regulatory …

Noon – 1:30 pm (EST) Social Media is increasingly being adopted as a tool for promoting medical devices. However, use of these various platforms (e.g., Facebook, Twitter, Pinterest, etc.) has become an area of particular interest by regulators as evidenced by recent FDA Guidance and Warning …

12:00 to 1:30pm

Frank will be speaking about Exploring FDA’s Flexibility with Novel Orphan Therapies. James Valentine will be a panel member of The Value of the Patient Perspective Hilton Alexandria Mark Center Hotel 5000 Seminary Rd, Alexandria, VA 22311 (703) 845-1010

Jeff Gibbs is speaking at the Digital Pathology Association – Pathology Visions. His presentation will be about “Regulatory Updates.” Hyatt Regency San Francisco 5 Embarcadero Center San Francisco, CA 94111

Hotel Monaco, Washington, DC This one-day conference focuses on significant developments in the federal regulation of tobacco products. The program brings together government, industry and public interest experts to provide updates on the latest developments in FDA tobacco product regulation. With guidance from expert speakers, participants …

The Toll House Hotel 140 S. Santa Cruz Avenue Los Gatos, CA 95030 Thursday 8:30 a.m. to 4:30 p.m. PCT / Friday 8:30 a.m. to 12:30 p.m. PCT

HP&M Attorneys to Present CLE Telephone Seminar on FSMA. The seminar is scheduled at at noon on October 16. In conjunction with Virginia CLE, Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal and Senior Counsel Brian Donato are presenting a 2-hour CLE telephone seminar that …

ASEA Conference Center 1575 I Street, NW Washington, DC 20005 McPherson Square Metro A “Generally Recognized as Safe” (GRAS) Determination is a science-based process that employs the most comprehensive toxicological and exposure data, as analyzed critically and independently by experts qualified in their respective sub-disciplines to evaluate the safety …

Norton Rose Fulbright 98 San Jacinto Blvd #1100 Austin, Texas 78701 We hope that you can join us for the 2014 Current Issues in Pharmaceutical and Medical Device Litigation on Thursday, October 9, 2014, at Norton Rose Fulbright in Austin, Texas.

Kurt Karst will be speaking about “New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges” Inter Continental Hotel 505 North Michigan Avenue Chicago IL 60611

James Valentine is speaking at Global Engage’s: Orphan Drugs, Collaborations & Market Access Congress. His presentation will be about “Opportunities for Rare Disease Patients in Regulatory Decision-Making” Town and Country Hotel 500 Hotel Circle North SAN DIEGO, CA 92108

At the Beaver Hollow Conference Center 1083 Pit Road Java Center, New York 14082

For decades, FDA has asserted that it has the authority to regulate laboratory-developed tests (LDTs). But on July 31, 2014, FDA took its biggest steps yet toward actively regulating such tests: FDA notified Congress of its intent to issue two draft guidance documents regarding oversight …

Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Omni Parker House Boston Boston, MA

David Clissold will be Presenting at GTC’s 4th Annual CNS Diseases World Summit. Sheraton Fisherman’s Wharf Hotel 2500 Mason Street San Francisco, CA 94133 (415) 362-5500

HPM’s Jay W. Cormier will be a panel member at Livestock the Biotech Summit. He will be on the Biomedical Regulatory Pathway Panel. The panel will be discussing Applications of animal biotechnology to solve biomedical questions. This panel will discuss the regulatory paradigm for where …

Senate Help Committee Briefing organized by NORD on Expanded Access to Investigational Drugs

James Shehan spoke about FDA Regulation of the Promotional Products Industry at the Promotional Products Association International Product Safety Summit.

Jeff Gibbs authored and article “FDA Announces Intention to Regulate LDTs as Devices” for Genetic Engineering & Biotechnology News In 1992, the Food and Drug Administration (FDA) first stated that it had authority to regulate laboratory-developed tests. On July 31, FDA took its biggest step toward …

10:30AM – 3:30 PM Hyman, Phelps & McNamara, P.C 700 13th Street, NW Suite 1200 Washington, DC 20005 Ricardo Carjaval at the conference. In light of recent developments and increasing scrutiny of the GRAS process, our newest Dialogue Is the GRAS Process Broken? is both extremely …

Jeffrey K. Shapiro is presenting :RAPS Webinar – Updates on Medical Device Post-Market Reporting Regulations Tuesday July 22, 2014  1:00PM EST to 2:30PM EST Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the …

Jeffrey K. Shapiro will be speaking about Medical device reporting. Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account …

Douglas B. Farquhar From Hyman, Phelps & McNamara, P.C. will be a moderator at this conference. This conference, specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, will drill down into how FDA evaluates company compliance with good manufacturing practices, specifically detailing what …

James C. Shehan is speaking at the 2014 BIO International Convention San Diego Convention Center

Alan Kirchenbaum presented speaking at the ACI – Prescription Drug Pricing conference. To get an E-Doc of the conference you can order it through the link below.

Jeff Shapiro is participating in a workshop on “Regulatory Landscape: Look Forward” at the American Association for the Advancement of Science conference: “Exploring Legal Challenges to Fulfilling the Potential of Health in a Safe and Responsible Environment” 1200 New York Avenue, NW, Suite 550 Washington, DC

Josephine Torrente speaking on “Formal Dispute Resolution at CDER: When, Why and How – Strategy for Discussing Formal Dispute Resolution” at the DIA Annual Meeting. San Diego, CA

James Valentine is speaking at the DIA Annual Meeting on Patient Fellowship Workshop; Breakout Session Title: Developing strategies for advocating and engaging the FDA and other regulatory agencies Patient Voice in Decision Making: How are Regulators Making This Work?; Presentation Title: Patients Voice in Decision Making: …

Kurt Karst is speaking at the ACI – Hatch-Waxman Boot Camp in Chicago, IL InterContinental Chicago Magnificent Mile 505 North Michigan Avenue Chicago, IL 60611 Reservations: 800-628-2112

ABA – 2014 Section of Litigation Food & Supplements Workshop. This years one-day program will be held at Cargill, Incorporated in Wayzata, MN. They have lined up a great group of speakers on the important topics affecting the food industry including the following: Emerging Issues: …