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CfPA-The Center for Professional Advancement, New Brunswick, NJ
December 7-8, 2015
Who Should Attend?
This course is intended to train individuals in the pharmaceutical and biopharmaceutical industries involved in all phases of clinical research including:
• Clinical Research Monitors
• Clinical Research Associates
• Clinical Research Coordinators
• Clinical Investigators
• Clinical Regulatory
• Statisticians
• Medical Communications
These Good Clinical Practice (GCP) regulations and EU Directives are to assure the validity of data resulting from all phases of clinical research. Course Description
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Organized by:
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CfPA-The Center for Professional Advancement |
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Invited Speakers:
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| Richard A. Guarino, MD; President, Oxford Pharmaceutical Resources, Inc. |
Dr. Richard A. Guarino is President of Oxford Pharmaceutical Resources, Inc., a Consulting Clinical and Regulatory Organization specializing in the planning, implementing and submitting INDs, NDAs, in the CTDs format. Dr, Guarino has 35 years of experience in new drug applications, marketing launches, pharmaceutical and product advertising, and FDA Liaison. He was formerly the President and CEO of Oxford Research International Corp. one of the largest CRO's 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, (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 5th edition. It is the first book ever written to guide and recommend ways to expedite the new drug approval process while following all the requirements of the US Code of Federal Regulations, EU Directives and ICH Guidelines.
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 Sovereign Military Hospitaller Order of Saint John of Jerusalem of Rhodes and of Malta American Association, USA 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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sberg@cfpa.com
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FDA’s Clinical Bio-Research Monitoring Program (BIMO) and EU Directives monitoring program will be discussed. The practical procedures in training monitors in how to audit clinical research data and how to avoid mis-entries and correct case report forms while complying with regulations will be detailed. The procedures in reporting adverse experiences and adverse reactions in order to meet FDA and international regulations will also be presented. Participants will have the opportunity to attend a workshop that will give the learner a practical exercise in monitoring obligations.