MLU
PHA.06114.01 - F-PhBT: Legal and economical aspects of pharmaceutical biotechnology (Vollständige Modulbeschreibung)
Originalfassung Englisch
PHA.06114.01 5 CP
Modulbezeichnung F-PhBT: Legal and economical aspects of pharmaceutical biotechnology
Modulcode PHA.06114.01
Semester der erstmaligen Durchführung
Fachbereich/Institut Institut für Pharmazie
Verwendet in Studiengängen / Semestern
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Akkreditierungsfassung gültig ab WS 2019/20 > Spezialisierung Pharmaceutical Biotechnology
  • Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Akkreditierungsfassung (WS 2015/16 - SoSe 2023) > Spezialisierung Pharmaceutical Biotechnology
Modulverantwortliche/r
Weitere verantwortliche Personen
R. Szczesny
Teilnahmevoraussetzungen
Kompetenzziele
  • 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 overlaps
  • 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
Modulinhalte
Course F-PhBT.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 quality
  • European, US, and other pharmacopoeiae of international importance
Course F-PhBT.2: Good Manufacturing Practice %u2013 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-PhBT.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
Lehrveranstaltungsformen Seminar (1 SWS)
Kursus
Seminar (1 SWS)
Seminar (2 SWS)
Unterrichtsprachen Deutsch, Englisch
Dauer in Semestern 1 Semester Semester
Angebotsrhythmus Modul jedes Sommersemester
Aufnahmekapazität Modul unbegrenzt
Prüfungsebene
Credit-Points 5 CP
Modulabschlussnote LV 1: %; LV 2: %; LV 3: %; LV 4: %.
Faktor der Modulnote für die Endnote des Studiengangs 1
Modulveran­staltung Lehrveranstaltungs­form Veranstaltungs­titel SWS Workload Präsenz Workload Vor- / Nach­bereitung Workload selbstge­staltete Arbeit Workload Prüfung incl. Vorbereitung Workload Summe
LV 1 Seminar Project seminar 1 0
LV 2 Kursus Private study 0
LV 3 Seminar Project seminar 1 0
LV 4 Seminar Project seminar 2 0
Workload modulbezogen 150 150
Workload Modul insgesamt 150
Prüfung Prüfungsvorleistung Prüfungsform
LV 1
LV 2
LV 3
LV 4
Gesamtmodul
Klausur
Wiederholungsprüfung
Regularien Teilnahme­voraussetzungen Angebots­rhythmus Anwesenheits­pflicht Gewicht an Modulnote in %
LV 1 Sommersemester Nein %
LV 2 Sommersemester Nein %
LV 3 Sommersemester Nein %
LV 4 Sommersemester Nein %