PHA.06114.01 - F-PhBT: Legal and economical aspects of pharmaceutical biotechnology (Complete module description)

PHA.06114.01	5 CP
Module label	F-PhBT: Legal and economical aspects of pharmaceutical biotechnology
Module code	PHA.06114.01
Semester of first implementation
Faculty/Institute	Institut für Pharmazie
Module used in courses of study / semesters	Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Version of accreditation valid from WS 2019/20 > Spezialisierung Pharmaceutical Biotechnology Pharmaceutical and Industrial Biotechnology (MA120 LP) (Master) > Pharmazie PharmacIndusBiotech.MA120, Version of accreditation (WS 2015/16 - SoSe 2023) > Spezialisierung Pharmaceutical Biotechnology
Responsible person for this module
Further responsible persons	R. Szczesny
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 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
Module contents	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
Forms of instruction	Seminar (1 SWS) Course Seminar (1 SWS) Seminar (2 SWS)
Languages of instruction	German, English
Duration (semesters)	1 Semester Semester
Module frequency	jedes Sommersemester
Module capacity	unrestricted
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 independent learning	Sum workload
Course 1	Seminar	Project seminar	1		0
Course 2	Course	Private study			0
Course 3	Seminar	Project seminar	1		0
Course 4	Seminar	Project seminar	2		0
Workload by module				150	150
Total module workload					150

Examination	Exam prerequisites	Type of examination
Course 1
Course 2
Course 3
Course 4
Final exam of module		Klausur
Exam repetition information

Prerequisites and conditions	Frequency	Compulsory attendance	Share on module grade in percent
Course 1	Summer semester	No	%
Course 2	Summer semester	No	%
Course 3	Summer semester	No	%
Course 4	Summer semester	No	%