The
Office of Enterprise Development
presents
The Commercialization Pathway
Short course series in Intellectual Property and Regulatory Reimbursement
The University of Pittsburgh’s Offices of Enterprise Development and Technology Management are sponsoring a five-part series to give participants in-depth information on the value of intellectual property and the importance of understanding regulatory and reimbursement issues. The sessions occur on consecutive Tuesdays, beginning April 21st and ending on May 19, 2009, All sessions will be held in Alumni Hall Room 532 (on 5th Avenue between Lytton and Tennyson Avenues) from 5-8pm. A light dinner is provided.
Course
summary
Intellectual Property
Regulatory and Reimbursement
Course Application
Intellectual Property, a three-part series
5-8pm
April 21, April 28, and May 5, 2009
Cost: $100.00 for all three sessions
Alumni Hall, 532
These sessions cover a variety of topics relating to intellectual property, including successful issue of patents, the anatomy of a patent, prior art, drafting patent applications, office actions, and prosecuting patents. Lawyers teaching this course include the following:
- Debra Anderson, J.D., is a patent lawyer with Meyer Unkovic & Scott LLP. More
- Chiara Orsini, M.B.A., J.D., is the Associate Director, Intellectual Property of the University of Pittsburgh's Office of Technology Management. More
- Allen Black Jr., Ph.D., J.D., is a lawyer with Hirshman Law, LLC. More
- Jesse A. Hirshman, J.D., is the principal in Hirshman Law, LLC. More
- David Oberdick, J.D., is a patent lawyer with Meyer, Unkovic & Scott LLP. More
Regulatory/Reimbursement, a two-part series
5-8pm
May 12 and May 19, 2009
Cost: $100.00 for both sessions
Alumni Hall, Room 532
These sessions provide valuable information on the regulatory and reimbursement requirements and issues for drugs, biologics, tissue engineering, devices, and combination devices, and in vitro diagnostics
Part A:
Drug Regulatory and Reimbursement, May 12, 2009
This session will examine the breadth of regulatory and pricing issues facing organizations in the biotechnology and pharmaceutical industry as well as both the challenges and opportunities driven by regulatory policies, pricing and reimbursement. The focus of this examination will be on the drug and biologics industry. The session will cover the impact of regulatory compliance on both established and emerging business including the influence of regulatory compliance and reimbursement on strategy, budget, fund raising, and market. Macro issues related to fostering innovation and managing risk will form the foundation of the course material and class discussion.
The session is taught by:
- Harold (Hank) Safferstein, M.B.A., Ph.D., J.D., who is Executive in Residence at the Pittsburgh Life Sciences Greenhouse. More
Part B:
Medical Device Regulatory Requirements, May 19, 2009
This session will introduce the participant to the general regulatory requirements for the marketing of medical devices in the major worldwide markets (U.S., EU & Japan). In particular, the course will cover the general classification, clinical, approval, compliance, quality system, labeling and post-market requirements for medical devices. Particular emphasis will be placed on regulations and requirements promulgated by the U.S. FDA under the Food Drug and Cosmetic Act as well as the general requirements under the primary Medical Devices Directives issued by the European Community. The participant will learn the major regulatory burdens, average timelines, and expected costs associated with obtaining device approvals, performing pre-approval clinical studies, and post-marketing requirements.
This session is taught by:
- Chad Coberly, M.B.A., J.D., who is Vice President of Clinical, Regulatory and Legal Affairs, Cohera Medical, Inc. More