[March 28, 2011]

Research and Markets: New Drug Approval Process, Fifth Edition Contains the Latest Regulatory Requirements for Expediting New Drug Approvals

Research and Markets (http://www.researchandmarkets.com/research/e94265/new_drug_approval) has announced the addition of the "New Drug Approval Process, Fifth Edition" book to their offering.

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed. Updated chapters include:

• advances in international regulatory requirements, including ICH guidelines and harmonization
• a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs
• the latest regulatory requirements for expediting new drug approvals
• strategies for effective commnication and integration of pharmaceutical personnel in all aspects of new drug development

• Preface.
• Introduction.
• Part I. Regulatory Practices and Procedures of New Drug, Biologic, and Device Development.
• Drug Development Teams.
• Nonclinical Drug Development: Pharmacology, Drug Metabolism, and Toxicology.
• The Investigational New Drug Application (IND), The Investigational Medicinal Product Dossier (IMPD), and the Investigator's Brochure (IB).
• The New Drug Application, Content and Format.
• Abbreviated and Supplemental New Drug Applications.
• The Biologics License Application (BLA).
• Device Legislation and Application.
• Orphan Drugs.
• Part II. Clinical Research Development.
• Clinical Research Protocols.
• Adverse Experiences, Adverse Reactions, Interactions and Postmarketing surveillance.
• Industry and FDA Liaison.
• Part III. Specific Aspects in the Process of New Product Submissions.
• Manufacturing and Control Requirements for the Chemistry Sections of the NDA and ANDA.
• Combination Products.
• Data Presentation for FDA Submissions: Text and Tabular Exposition.
• Technology Change - Enabling Clinical Research and Drug Development Processes.
• The Common Technical Document for the Registration of Pharmaceuticals for Human Use.
• Part IV. Global Application of Good Clinical Practices (GCPs).
• CFR/ICH/EU GCP Obligations of Investigators, Sponsors, and Monitors.
• Institutional Review Board/Independent Ethics Committee and Informed Consent: Protecting Research Subjects in U.S. and Foreign Clinical Trials.
• Quality Assurance.
• Managing Clinical Trials.
• The European Union Directive on Good Clinical Practice in Clinical Trials: Implications for Future Research.
• HIPAA: A New Requirement to the Clinical Study Process.
• Part V. Effective and New Methodologies in Expending New Product Approvals in the U.S. and European Union.
• Working with a Contract Research Organization (CRO).

For more information visit http://www.researchandmarkets.com/research/e94265/new_drug_approval

Source (News - Alert): Informa Healthcare

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