Research and Development of Vaccines and Pharmaceutical form Biotechnology – A Guide to Effective Project Management, Patenting

Jens-Peter Gregersen is the author of Research and Development of Vaccines and Pharmaceuticals from Biotechnology: A Guide to Effective Project Management, Patenting and Product Registration, published by Wiley.

From the Contents: Preface Biotechnology in Pharmaceutical Research A Scientific Leap Forward Biotechnology in the 1990's Research Structures Basic or Applied Research or Where do you want to get to? The Aim of a Project Defining the Aim Creative Market Research and Other Valuable Background Information Project Planning The Backwards Approach to establish a Plan Linking Project Tasks Objectives and Milestones Time and Task Dependencies Project Team Approval and Refinement of the Plan Allocation of Resources and Budget Planning Changes to the Plan Implementing a Project Plan Project Management Computer Software Product Development Product Development Follows Different Rules Commercial Chances and Risks of Pharmaceutical Development Product Profile and Market Assessment of Development Products - Planning and Managing Product Development - Technical Aspects of Product Development Patents for Biomedical Products The Purpose of the Patent Alternatives to Patents - Basic Requirements for a Patentable Invention - The Patent Application - Selling an Invention, Licences and Royalties Registration Requirements - Three Basic Elements - Registration Applications and Procedures - Requirements for the Preclinical Pharmacology and Safety Assessment - Additional Preclinical Studies for Veterinary Products - Annex A: Outline of Major Registration Requirements - Annex B: References and Information Sources on Regulatory Matters References Index