3 ECTS credits
78 h study time
Offer 1 with catalog number 4023427ENR for all students in the 1st semester
at
a (E) Master - advanced level.
- Semester
- 1st semester
- Enrollment based on exam contract
- Impossible
- Grading method
- Grading (scale from 0 to 20)
- Can retake in second session
- Yes
- Enrollment Requirements
- Om een inschrijving te kunnen nemen voor ‘Regulatory affairs’ moet men :
Geslaagd zijn voor minstens 165 ECTS van de bachelor FW
EN geslaagd zijn voor alle opleidingsonderdelen van het eerste jaar en het tweede jaar van de bachelor FW
EN geslaagd of ingeschreven zijn voor alle opleidingsonderdelen van het derde jaar van de bachelor FW
EN geslaagd of ingeschreven zijn voor Drug quality control
- Taught in
- Dutch
- Faculty
- Faculteit Geneeskunde en Farmacie
- Department
- Pharmaceutical and Pharmacological Sciences
- Educational team
- An Van Hemelrijck
(course titular)
- Activities and contact hours
- 26 contact hours Lecture
- Course Content
- Health Care Regulatory Affairs
- Introduction to Regulatory Affairs, incl pharmaceutical legislation
- Definition of a medicinal product & borderline products
- Legal basis of an application and EU data and market protection rules
- The Common Technical Document and Regulatory operations
- Product information and labelling
- EU procedure for Marketing Authorisation, including role of the EU institutions, NCA, EDQM
- LCM: Variations, Renewals, Line extensions etc..
- Regulatory science & strategy
- Scientific advice and protocol assistance, Adaptive pathways, PRIME
- Orphan medicines
- Paediatric regulation
- Stakeholder interactions: HTA (& pricing), patient centricity
- Hot topics (can be different each year)
- Regulatory technical case study
- Quality – Module 3
- Biologicals, vaccines
- QbD
- Role of the QP
- Pre-clinical development – Module 4
- PK, PD, toxicology
- Ethics, 3R
- Clinical – Module 5
- Clinical Development, early phase development
- Clinical trial regulation, CU and MN
- Pharmacovigilance
- PhVig System and PSMF
- RMP, PSUR, PASS/PAES
- EU QPVV, Local Contact PhVig
- Advertising and promotion
- Course material
- Digital course material (Required) :
- Additional info
................................
- Learning Outcomes
-
Algemene competenties
The student knows the requirements of a Common Technical Document.
The student can explain the course of the European procedures for approval of medicinal
products.
The student knows the different procedures to obtain a marketing authorisation for
medicinal products.
The student has notions of a paediatric investigational plan (PIP).
The student understands the procedures for pharmacovigilance en is able to apply these
procedures.
De student kent de vereisten van een Common Technical Document.
De student kan het verloop van Europese goedkeuringsprocedures voor geneesmiddelen toelichten.
De student kent de verschillende procedures om een vergunning voor het in de handel brengen van een geneesmiddel te bekomen.
De student heeft noties van een paediatric investigational plan (PIP).
De student begrijpt de procedures voor farmacovigilantie en kan deze toepassen.
- Grading
-
The final grade is composed based on the following categories:
Written Exam determines 100% of the final mark.
Within the Written Exam category, the following assignments need to be completed:
- Written exam
with a relative weight of 100
which comprises 100% of the final mark.
- Additional info regarding evaluation
Written exam
- Allowed unsatisfactory mark
- The supplementary Teaching and Examination Regulations of your faculty stipulate whether an allowed unsatisfactory mark for this programme unit is permitted.
Academic context
This offer is part of the following study plans:
Master of Drug Development: Pharmacist (only offered in Dutch)
Master of Drug Development: AR without officinastage (only offered in Dutch)