PHA.03536.02 - Legal and economical aspects of pharmaceutical biotechnology (Vollständige Modulbeschreibung)

Prof. Dr. P. Imming

• Understanding of drug quality requirements, pre-requisites and activities • Basic knowledge of the European drug quality system • Connection of the European system with international regulations, differences and over-laps • Knowledge of basic concepts for GMP and on differences between European and US regulations • Knowledge of the basic concepts of a) Strategic & business planning (corporate, marketing, financial, R&D) b) value assessment of developmental projects and intellectual properties with simple standard methods (NPV, double-sided NPV, benchmarking etc) c) portfolio strategy d) structuring cooperation agreements e) patent assessment and trading intellectual properties (licensing) f) alliances and joint ventures • Drafting and evaluation of different forms of cooperation agreements • Calculating value of a particular product in development • Understanding and drafting a commercial term sheet for licensing of a particular product from a development to a distributor company • Drafting a business plan

Course F.1: Drug quality control - European and international standards and regulations • Requirements for drugs: efficacy, safety, quality • Drug quality: definitions, legal requirements, standards, methods • Good Manufacturing Practices, emphasis on quality; CPMP and ICH guidelines on qual-ity • European, US, and other pharmacopoeiae of international importance
Course F.2: Good Manufacturing Practice - European and international regulations • European GMP regulations • Application of GMP guidelines for biotechnology • Aseptic processing • Qualification of materials and devices for pharmaceutical manufacturing • Process validation • GMP compliant documentation • Qualified persons in GMP manufacturing • Modern concepts for `Quality by Design` and Process Analytical Technology
Course F.3: Economical and marketing aspects, patents and licensing • Strategic planning • Business Plan • Value assessment • Important legal issues for structuring different cooperation agreements • Evaluation of Intellectual Properties • Trading with Intellectual Properties • Exercise Course based on a case study

Klausur