740873 VO Market Access, Analysis of Medical Demand, Production and Distribution of Authorised Medicinal

summer semester 2024 | Last update: 31.03.2025 | Place course on memo list

Department:

Department of Pharmacy

Instructor:

Dr. Michael Demel, MSc
Dr. Anja Huth
Dr. iur. Roland Pichler
Ilda Sabanovic Polimac, MSc

Course number:

740873

Title:

VO Market Access, Analysis of Medical Demand, Production and Distribution of Authorised Medicinal

Type/hours:

VO 1

ECTS credits:

1,5

Period:

Block

Mode of repetition:

annually

Language of instruction:

English

Learning Outcome:

Students understand the process of market access (including Compassionate Use, Named Patient Programme, Temporary Use, Authorisation/Recommendation), principles of medical demand, analysis and production, distribution of the medicinal products and pricing/reimbursement.

Contents:

•    Early Access/ Compassionate Use from a regulatory perspective (Europe with a focus on Germany)
•    Access to medicines in the Austrian health care system
•    Reimbursement in the in-patient & out-patient sector (incl. funding and financing of vaccines)
•    Process of application for drug reimbursement and possible reimbursement strategies
•    Drug pricing, innovative pricing models & International reference pricing
•    Evaluation of innovative drugs: national vs. European assessment boards incl. HTA
•    Management of the product life cycle (from innovative drugs to generics and biosimilars)
•    Data generation / Real-world evidence
•    Building partnerships in the healthcare system (Stakeholder-Landscape, -Mapping & -Management)

Methods:

Lecture with interactive elements involving student participation, audience response systems, online handouts

Assessment:

written exam

Prerequisites:

Modules 1 and 2

OLAT:

https://lms.uibk.ac.at/url/RepositoryEntry/5615255646

Start:

see dates

Course allocation

Faculty of Chemistry and Pharmacy

Master's Programme Pharmaceutical Sciences - Drug Development and Regulatory Affairs according to the curriculum 2022 (120 ECTS-Credits, 4 semester)

Compulsory Modules (80 ECTS-Credits)

Compulsory Module 7: Matters of Medicines Regulation and Market Approval (7.5 ECTS-Credits, 4 h)

Dates

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Date	Time	Location
Mon 2024-06-10	11.00 - 12.00	Auswärtiger Ort Auswärtiger Ort	Histologie-HS (Müllerstraße 59, 2. Stock, Raum Nr. 308)
Tue 2024-06-11	09.00 - 10.00	Auswärtiger Ort Auswärtiger Ort	Histologie-HS (Müllerstraße 59, 2. Stock, Raum Nr. 308)
Thu 2024-06-20	12.00 - 17.00	Auswärtiger Ort Auswärtiger Ort	Histologie-HS (Müllerstraße 59, 2. Stock, Raum Nr. 308)
Fri 2024-06-21	09.00 - 14.00	Auswärtiger Ort Auswärtiger Ort	Histologie-HS (Müllerstraße 59, 2. Stock, Raum Nr. 308)
Fri 2024-07-12	10.00 - 12.00	Auswärtiger Ort Auswärtiger Ort	1. Prüfungstermin - Histologie-HS (Müllerstraße 59, 2. Stock, Raum Nr. 308)
Mon 2024-07-22	10.00 - 12.00	L.03.121 L.03.121	Prüfung
Mon 2024-09-16	09.00 - 11.00	L.03.121 L.03.121	Sammelprüfung