Events | Hyman, Phelps & McNamara, P.C.

Events

James Valentine is presenting at the DIA 2015 Annual Meeting: "The Growing Role of the Patient Leading Into PDUFA VI: Negotiations and 2016"June 15th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
Kurt Karst is presenting at the Drug Information Association: Annual MeetingJune 14th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
Alexander Varond will be presenting at the DIA 2015 Annual MeetingJune 14th, 2015
The DIA 2015 51st Annual Meeting is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines come together each June all with a common goal to foster innovation that will lead to the development …
Michelle Butler is presenting at the 2015 FDA-OCRA Annual Educational Conference, Reg Affairs DiscussionJune 3rd, 2015
June 3 is Plenary Sessions in AM and Three Breakouts in the PM: 1. Clinical Trials Breakout Sessions – Back by Popular Demand 2. International Breakout Sessions – New Breakout Session 3. Dietary Supplements Breakout Sessions June 4 is Half Day Breakout Sessions in the AM 1. Medical Devices and …
James C. Shehan is presenting at the Academy of Managed Care Pharmacy Webinar – Current Constructs for MCO Speciality Decision Making, DocumentationJune 2nd, 2015
Academy of Managed Care Pharmacy Webinar _ Current Constructs for MCO Specialty Decision Making, Documentation and Transparency _ What are the Components that Change with Biosimilars?; 1 pm
Doug Farquhar is speaking at the DIA: FDA International InspectionsJune 1st, 2015
Jennifer Newberger is presenting at the ABA Family Law 2015 Spring CLE ConferenceMay 6th, 2015
May 6-9, 2015 Park Hyatt Aviara 7100 Aviara Resort Drive Carlsbad, CA 92011
Kurt Karst is speaking at the RDD Europe 2015May 5th, 2015
The meeting format will include: • In-depth discussions of the developing issues surrounding aerosol drug delivery including new therapeutic opportunities and drug design technologies, progress in drug development alongside novel in vitro and in vivo testing methods, regulatory science… and much more. • Scientific Poster Sessions covering …
Riette van Laack will be presenting at the Protein Trends & Technologies SeminarMay 5th, 2015
Pre-Conference Program: Business Strategies. This day will focus on fundamental and ever-changing factors impacting the global protein ingredient market. The information is crucial for anyone guiding their protein ingredient business or for those where the protein ingredient marketplace has significant impact on their business. Examples of …
Bob Dormer is presenting at the Florida Medical Manufacturers ConsortiumMay 4th, 2015
The 2015 Florida Medical Device Symposium will be held May 4-5, 2015, at the Hilton Carillon Park in St. Petersburg. The symposium is Florida’s premier event for medical device manufacturing firms, featuring nationally recognized speakers, expert panels on regulatory issues and industry trends, legislative updates …
Diane McColl is presenting at the Food Hydrocolloid ConferenceApril 26th, 2015
Miami, Florida – April 26-28
Jeff Gibbs is speaking at the AMDM Annual ConferenceApril 22nd, 2015
Bethesda North Marriott Hotel and Conference Center 510(k) Submissions Workshop, April 20-21, 2015 Pre-Submissions Workshop , April 21, 2015 AMDM Annual Meeting, April 22-23, 2015
Riette van Laack will be presenting at the Spring Short Causes 2015March 25th, 2015
What Labeling Requirements and Implications for Foods Marketed in the U.S. When March 25-26, 2015 Where Hyatt Regency Orange County 11999 Harbor Boulevard Garden Grove, California Description Event – General Information Labeling Requirements and Implications for Foods Marketed in the U.S. Event Website URL Through this introductory course, participants will examine the legal naming of …
Anne Walsh is presenting at the Forum on Fraud and Abuse in the Sales and Marketing of Medical DevicesMarch 12th, 2015
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 expected to continue its heightened enforcement efforts. The …
Kurt Karst is speaking at the FDA Boot CampMarch 10th, 2015
Doubletree Suites by Hilton Times Square 1568 Broadway New York, NY 10036 Now in its 24th iteration, FDA Boot Camp is the premier event that will provide you with the ultimate roadmap to the complicated landscape of FDA regulatory law. ACI’s FDA Boot Camp has been designed by leading …
Jeff Gibbs is presenting at the 2015 Annual Membership Meeting – Hearing Industries AssociationMarch 4th, 2015
Frank Sasinowski will be speaking at the 24th Annual Adler Symposium on Alzheimers ResearchFebruary 3rd, 2015
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 …
Josephine Torrente and James Valentine will be presenting at the Expanded Access ProgramsFebruary 3rd, 2015
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 …
Paul Hyman will serve as a panel member for the Annual Legal, Regulatory and Compliance Forum on CosmeticsJanuary 27th, 2015
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 …
Anne Walsh is presenting at the Enforcement, Litigation and Compliance ConferenceDecember 8th, 2014
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 …
Jim Shehan is speaking at the Specialty Drug Cost Management and Medication Adherence ConferenceNovember 20th, 2014
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. …
John Fleder and Jeff Shapiro will be presenting at the Advertising and Promotion of Medical Devices ConferenceNovember 18th, 2014
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 …
Kurt Karst is speaking at the Respiratory Drug Delivery Asia 2014November 12th, 2014
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 …
Jim Shehan is speaking at the 1st ever MassBio Patient Advocacy SummitNovember 10th, 2014
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 …
John Gilbert is speaking at the American Society for Pharmacy Law – Developments in Pharmacy LawNovember 6th, 2014
Hyatt Regency Indian Wells Resort & Spa 44600 Indian Wells Lane Indian Wells, California, USA, 92210
Melisa Moonan is a Panel Member at the 2014 Connected Care Exchange ConferenceNovember 4th, 2014
Jim Shehan is speaking at the 3rd International Conference and Exhibition on Biowaivers, Biologics and BiosimilarsOctober 29th, 2014
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 …
James Valentine will be facilitating a session at DIA – Patient Engagement throughout the Full Spectrum of Drug Development: An Interactive WorkshopOctober 29th, 2014
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
Jeff Gibbs is speaking at the Digital Pathology Association – Pathology Visions 2014October 21st, 2014
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
Dave Clissold is speaking at the 2014 FDA Regulation of TobaccoOctober 21st, 2014
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 …
Dave Clissold will serve as a Panel Member for the FDA Regulation of Tobacco 2014October 21st, 2014
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 …
Hyman, Phelps & McNamara jointly with Barton and Blank present the webinar: Medical Device Promotion on Social MediaOctober 21st, 2014
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 …
Jeff Shapiro is co-presenting a Webinar on Medical Device Promotion on Social Media: Regulatory Considerations and Best PracticesOctober 21st, 2014
12:00 to 1:30pm
Frank Sasinowski and James Valentine will be speaking and presenting at NORD Rare Diseases and Orphan Products Breakthrough SummitOctober 21st, 2014
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 Association of Medical Diagnostics Manufacturers – 2014 IVD Focus MeetingOctober 16th, 2014
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
Ricardo Carvajal and Brian Donato are presenting a 2-hour CLE telephone seminar on the Food Safety Modernization ActOctober 16th, 2014
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 …
Diane McColl hosted A Workshop on GRAS Determinations for the International Society of Regulatory Toxicology and Pharmacology ("ISRTP")October 13th, 2014
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 …
Allyson Mullen will be speaking on a panel at the 2014 ABA Regional Pharmaceutical and Medical Device Regional CLE SeminarOctober 9th, 2014
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 is speaking at the Paragraph IV Disputes Master SymposiumSeptember 30th, 2014
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 – Orphan Drugs – Collaborations & Market Access CongressSeptember 29th, 2014
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
Frank Sasinowski is presenting at the 2014 Muscle Study Group Annual MeetingSeptember 21st, 2014
At the Beaver Hollow Conference Center 1083 Pit Road Java Center, New York 14082
Kurt Karst co-chair and speaker at ACI FDA Boot CampSeptember 18th, 2014
Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Omni Parker House Boston Boston, MA
David Clissold to Present at 4th Annual CNS Diseases World SummitSeptember 18th, 2014
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
Jay W. Cormier will be a panel member at Livestock the Biotech Summit in Sioux Falls, SDSeptember 16th, 2014
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 …
Jim Shehan is presenting at the Senate Help Committee Briefing organized by NORD on Expanded Access to Investigational DrugsSeptember 11th, 2014
Senate Help Committee Briefing organized by NORD on Expanded Access to Investigational Drugs
Jim Shehan spoke at the Promotional Products Association International Product Safety SummitAugust 14th, 2014
James Shehan spoke about FDA Regulation of the Promotional Products Industry at the Promotional Products Association International Product Safety Summit.
Ricardo Carjaval will be presenting FDLI – Is the GRAS Process Broken? An FDLI Dialogue at HPMJuly 23rd, 2014
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 presenting – RAPS Webinar – Updates on Medical Device Post-Market Reporting RegulationsJuly 22nd, 2014
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 is presenting at the RAPS Webinar: Updates on Medical Device Post-Market Reporting RegulationsJuly 22nd, 2014
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 …
FDLI, Introduction to Orphan Drug Development and ExclusivityJuly 16th, 2014