Top Attorneys to Speak at UC Irvine Extension Medical Device Law Seminar

IRVINE, Calif. – October 5, 2001 – UC Irvine Extension has partnered with the law firm of Crosby, Heafey, Roach & May to create the industry's most comprehensive seminar on medical device law. The event will be held on October 26 and 27 from 9:00 a.m. to 4:00 p.m. at the UCI Learning Center, located at 200 South Manchester Avenue, Orange, Calif.

More than a dozen top attorneys from the firm's offices in San Francisco, Oakland, Century City and Los Angeles, as well as a partner from Hyman Phelps, are expected to speak on a variety of legal topics, including:

Financing a start-up company (including entity, intellectual property, stock/equity options, business plan, venture capital financing)
The ABCs of product liability law for drug, device, and biotech companies
Document retention
FDA enforcement (policies, practices and procedures)
Clinical trials
Licensing agreements
Post-market surveillance
Reuse of single use devices
Reporting adverse reactions to the FDA
Insurance
Mass tort coordination
Discovery of electronic data

GUEST SPEAKERS FROM CROSBY, HEAFEY, ROACH & MAY

James Wood specializes in product liability litigation representing manufacturers of prescription medicines, therapies and medical devices.
Twila Foster advises clients on the formation and financing of corporations, limited partnerships and limited liability companies, SEC reporting, mergers and acquisitions.
Dale Freeman is experienced in corporate entity formation, mergers and acquisitions, intellectual property/licensing alliances and general advice and counseling of the start-up and public client.
Michael Sanders is corporate counsel for start-up and emerging growth companies in the life sciences and information technology industries.
John Lino specializes in corporate securities, venture capital, mergers and acquisitions and international transactions.
Barry Thompson is an expert in product liability litigation.
Joan Haratani has extensive experience in trial and pre-trial work for medical device and pharmaceutical manufacturers.
Dave Bickham has handled numerous court and jury trials, and various types of alternative dispute resolution in both state and federal courts on behalf of medical device and pharmaceutical manufacturers.
Mike Buckley heads Crosby Heafey's Commercial Litigation Group and handles a variety of complex business suits.
Steve Kohn specializes in product liability, toxic tort, commercial and general business litigation.
Ginger Heyman handles professional liability claims with an emphasis on product liability matters.
Jack Nelson leads the firm's insurance industry practice and has handled corporate governance and business disputes, class actions, trade secret, D&O and professional liability cases.
Dave Stanley represents pharmaceutical, medical device and other companies in product liability matters and litigation involving breach of contract and other business disputes.
Thomas Freeman is experienced in multi-party civil litigation, including court and jury trials, and various types of alternative dispute resolution proceedings.
Stephanie Mendelsohn specializes in product liability and insurance litigation.
Thomas Gibson of Hyman Phelps is an expert on FDA enforcement.

Crosby, Heafey, Roach & May has been approved as a provider of Minimum Continuing Legal Education credit by the State Bar of California for this program.

For more information about these seminars or UC Irvine Extension's Certificate Program in Medical Product Development, please contact Rogelio Rodriguez at (949) 824-5380, rcrodrig@uci.edu, or visit Medical Product Development.

RELATED COURSES OF INTEREST

"Regulatory Requirements for the Medical Product Industry" covers key regulatory components, such as device classifications, medical device industry requirements, pharmaceutical industry requirements, safety regulations practices, clinical trials requirements, good manufacturing practices and inspections, labeling medical devices and writing FDA submissions.
"Medical Product Development Process" reviews basic industry statistics, current trends, and fundamental systems that are used in the design, development and manufacturing of medical devices. Participants will be involved in the creation of a product development plan as well as business plans to better ensure successful completion of product development tasks.
"Medical Device Manufacturing" focuses on the principles, challenges, and issues involved in medical manufacturing. Topics include: product development cycle, understanding the customer and their needs, material and process selection, packaging and sterilization, manufacturing regulations, reliability testing, design validation, and developing a manufacturing strategy.

University of California, Irvine Extension, the continuing education arm of the University of California, Irvine, offers over 1,600 university-level professional and personal enrichment courses, including 45 certificate programs and specialized studies every year. It serves over 12,000 students annually, most of whom already have college degrees. For the convenience of working adults, most courses are held evenings and weekends on the UC Irvine campus, the UC Irvine Learning Center in Orange and online.

The program also provides custom education and training programs at business sites worldwide. Instructors for all courses are highly qualified UCI-approved leading industry experts. UC Irvine Extension is financially self-supporting, deriving income primarily from course enrollment fees without the assistance of state funds. For more information regarding University of California, Irvine Extension courses and programs, log on to www.unex.uci.edu, email unex@uci.edu or call (949) 824-5414.