Section I. Administrative Guidelines for New Product Development

• Drug Development Teams
• FDA Approvable Indications and Other Considerations
• Data Presentation for Global Submissions: Text and Tabular Exposition
• Technology Change – Enabling Clinical Research and Drug Development Processes
• Working with a Contract Research Organization (CRO)
• US FDA Liaison

Section II. Global Regulatory Submission of Drugs, Biologics and Devices for New Product Approvals

• Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology
• The Investigational New Drug Application (IND) The Investigational Medicinal Product Dossier (IMPD), The Investigator's Brochure (IB)
• New Product Applications for Global Pharmaceutical Product Approvals: US NDA vs CTD Formats
• Abbreviated and Supplemental New Drug Applications (ANDAs and SNDAs) US Regulations
• The CTD and eCTD for the Registration of Pharmaceuticals for Human Use
• The Biologic License Application (BLA)
• Chemistry, Manufacturing and Control (CMC) (ICH Quality Guidelines)
• New Medical Device Approval Process in the United States
• Orphan Drugs

Section III. Developing Clinical Research Trials

• Clinical Research Protocols
• Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in U.S. and Foreign Clinical Trials
• HIPAA: A New Requirement to the Clinical Study Process
• Adverse Events and Reactions: Etiology, Drug Interactions, Collection and Reporting
• Biostatistics in Pharmaceutical Product Development-Facts, Recommendations, and Solutions

Section IV. Global Regulations for Good Clinical Practices (GCP)

• CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors
• Quality Assurance
• Managing and Monitoring Clinical Trials
• European CT Directive: Implementation and Update

Section V. Specific Areas of New Product Submissions

• Combination Products
• The Current State of GXP in China

Richard Guarino is President of Oxford Pharmaceuticals, Inc., and was the former CEO of Oxford Research International Corp. He is the editor of Informa Healthcare’s Fourth Edition of New Drug Approval Process, the first book to guide and recommend ways to expedite global new drug approval processes while also following meeting federal and industry requirements. Dr. Guarino is a member of the Lupus Erythematosus Foundation, the Cystic Fibrosis Foundation and the Columbus Foundation, Drug Information Association, Association of Clinical Research Professionals, and the Academy of Pharmaceutical Physicians and Investigators.