PHA.03536.02 | 5 CP |
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Module label | Legal and economical aspects of pharmaceutical biotechnology |
Module code | PHA.03536.02 |
Semester of first implementation | |
Faculty/Institute | Institut für Pharmazie |
Module used in courses of study / semesters |
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Responsible person for this module | |
Further responsible persons |
Prof. Dr. P. Imming |
Prerequisites | |
Skills to be acquired in this module | 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 |
Module contents | 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 |
Forms of instruction |
Lecture (2 SWS)
Lecture (1 SWS) Lecture (1 SWS) Course |
Languages of instruction | German, English |
Duration (semesters) | 1 Semester Semester |
Module frequency | jedes Sommersemester |
Module capacity | unlimited |
Time of examination | |
Credit points | 5 CP |
Share on module final degree | Course 1: %; Course 2: %; Course 3: %; Course 4: %. |
Share of module grade on the course of study's final grade | 1 |
Module course label | Course type | Course title | SWS | Workload of compulsory attendance | Workload of preparation / homework etc | Workload of independent learning | Workload (examination and preparation) | Sum workload |
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Course 1 | Lecture | Economical and marketing aspects, patents and licensing | 2 | 0 | ||||
Course 2 | Lecture | Drug quality control - European and international standards and regulations | 1 | 0 | ||||
Course 3 | Lecture | Good manufacturing practice - European and international regulations | 1 | 0 | ||||
Course 4 | Course | Selbststudium | 0 | |||||
Workload by module | 150 | 150 | ||||||
Total module workload | 150 |
Examination | Exam prerequisites | Type of examination | |
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Course 1 | |||
Course 2 | |||
Course 3 | |||
Course 4 | |||
Final exam of module | Klausur |
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Exam repetition information |
Prerequisites and conditions | Prerequisites | Frequency | Compulsory attendance | Share on module grade in percent |
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Course 1 | Summer semester | No | % | |
Course 2 | Summer semester | No | % | |
Course 3 | Summer semester | No | % | |
Course 4 | Summer semester | No | % |