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The Center for Professional Advancement, Burlingame, CA
March 10-12, 2008
Who Should Attend
This course is specifically designed for personnel in the pharmaceutical and biotechnology industries who need a detailed understanding of what comprises an IND, NDA, BLA, ANDA, SNDA, and CTD. This includes but is not limited to those involved in:- Pre-Clinical Research
- Regulatory Affairs
- Clinical Research
- Product Development
- CMC Components
- Management
- Quality Assurance
Participants should have a basic understanding of new product development and/or regulatory affairs in order to best comprehend the lectures presented in this course.Description
The content of this course is designed to present the intricate parts of INDs, NDAs, BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products will be based on the requirements of the US Code of Federal Regulations, the ICH Guidelines for global submissions and the EU Directives. Specifics of the IND, NDA, BLA, ANDA, SNDA and CTD will be detailed for safety, quality, and efficacy. Non and pre-clinical data, clinical data and CMC data to achieve product approvals globally will be enumerated for expediting new product approvals. Other subject areas include:- FDAs internal structure, policies, and procedures
- GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and Drug Master Files
- The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison
- Acceptance of foreign data for new product approvals, EU Directives on global submissions
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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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