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The Center for Professional Advancement, New Brunswick, NJ
February 11-12, 2008
Who Should Attend
This course is specifically designed for personnel in the pharmaceutical, biotechnology and related industries who use contract research organizations (CROs) for the discovery and development of new drugs, devices, and biologics. This includes, but is not limited to:- Scientists
- Managers
- Project Team Leaders
Participants should have some experience in the processes involved in new product submissions.Description
The content of this course will assist pharmaceutical and biotechnology researchers and managers and their counterparts in the CRO industry in understanding the requirements for a well-designed and successful outsourcing program that is completed on time, within budget, and in compliance with FDA regulations and ICH guidelines. The types of CROs and the various outsourcing requirements will be presented to assist in designing the sponsor-generated outsourcing program. Proposal solicitation and evaluation, site visits, contract negotiations, and other items necessary for identifying and selecting a CRO will be discussed. Research study planning, monitoring, problem assessment and correction, and other areas involved in successfully managing a CRO will be presented. FDA views and legal obligations of CROs and sponsors, including generation and review of study reports submitted in INDs and NDAs, will be detailed. Emphasis will be given to the overall management of CROs; how to resolve issues of monitoring, timeline lags, and effective communication.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Dr. Richard A. Guarino; President, Oxford Pharmaceutical Resources, Inc.
Richard A. Guarino, M.D. is President of Oxford Pharmaceutical Resources, Inc., a consulting organization specializing in the planning, implementing and submitting of INDs, NDAs and CTDs. Dr. Guarino also has 25 years of experience in new drug applications, in marketing launches, advertising, and FDA liaison.
Dr. Guarino was formerly the President and CEO of Oxford Research International Corp., one of the largest CROs in the United States. Besides serving as an adjunct professor at Fairleigh Dickinson University, he was a former Director of Clinical Research at Sandoz Pharmaceutical Inc., now Novartis, and held the position of Vice President/Medical Director at Revlon Healthcare Group. He has been acclaimed for his book, New Drug Approval Process, now in its 4th edition. It is the first book ever written to guide and recommend ways to expedite global new drug approval process while following all the requirements of the Code of Federal Regulations and EU Directives.
Dr. Guarino is a member of many professional societies and associations including the New Jersey and New York Academies of Medicine, The Royal Society of Medicine, the Columbus Citizens Foundation, the Presidential Advisory Cabinet at Fairleigh Dickinson University, the Lupus Erythematosus Foundation, the Cystic Fibrosis Foundation and the Columbus Foundation, Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), and Academy of Pharmaceutical Physicians and Investigators (APPI).
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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