COURSE UNIT TITLE

: PHARMACEUTICAL LAW

DEGREE PROGRAMMES

Description of Individual Course Units

Course Unit Code Course Unit Title Type Of Course D U L ECTS
TPH 5011 PHARMACEUTICAL LAW ELECTIVE 3 0 0 6

Offered By

Medical Law

Level of Course Unit

Second Cycle Programmes (Master's Degree)

Course Coordinator

ASSOCIATE PROFESSOR SERDAR NART

Offered to

Medical Law

Course Objective

The aim of this course is to determine the basic principles and concepts of drug law, to reveal the concept of drug and drug treatment in this framework, to discuss the legal aspect of preclinical and clinical research after the discovery of drugs with historical events and to determine the legal responsibilities of the physician, pharmacist and drug manufacturers due to drug.

Learning Outcomes of the Course Unit

1   Being able to determine the concepts of Pharmaceutical Law, Health Law, Medical Law and principles related to responsibility.
2   To be able to determine the products used in alternative treatment methods and some non-drug products with the concept of drug and drug treatment.
3   To be able to identify the concepts and stages of licensing processes from the discovery of drugs.
4   To determine the legal and ethical dimension of clinical trials and clinical trials.
5   To be able to evaluate scientific studies, judicial decisions and legislation in the field of Pharmaceutical Law.
6   To be able to detect problems in the field of drug law.
7   To determine the legal, criminal and administrative responsibilities of the manufacturer, physician and pharmacist due to the drug.
8   To determine the legal, criminal and administrative responsibilities of other healthcare professionals in drug treatment.

Mode of Delivery

Face -to- Face

Prerequisites and Co-requisites

None

Recomended Optional Programme Components

None

Course Contents

Week Subject Description
1 Pharmaceutical Law, Health Law and Medical Law Distinction
2 Historical development of drug law The discovery of the drug and the historical development of clinical research
3 Stages of clinical research Licensing of the drug
4 Drug treatment Definition of drug Products not qualified as pharmaceuticals
5 The definition and conditions of medical intervention Elements of drug therapy
6 Evaluation of the products used in these treatments with alternative treatment methods Features that distinguish drug treatments from other treatment methods
7 Medical science standards Alternative drugs Orphan drugs, off-label use
8 Euthanasia
9 Legal responsibility of the Producer in drug treatment Discussing responsibilities The legal nature of responsibility Conditions of responsibility The consequences of responsibility
10 Legal responsibility of the physician in drug treatment Discussing responsibilities The legal nature of responsibility Conditions of responsibility The consequences of responsibility
11 Administration's compensation responsibility Determination of compensation Evaluation of opinions on the necessity of drug law Pharmaceutical laws in terms of comparative law
12 Legal responsibility of the pharmacist in drug treatment Discussing responsibilities The legal nature of responsibility Conditions of responsibility The consequences of responsibility
13 Penal liability in drug treatment Possible crimes of the producer, pharmacist, physician
14 Financial responsibility of the administration in drug treatment Public service Service defect

Recomended or Required Reading

Hakan Hakeri, Ilaç Hukuku, Ankara 2015.
Serdar Nart : Hekimin Ilaç Tedavilerinden Doğan Hukuki Sorumluluğu, 2.bası, Ankara 2020.
Hasan Tahsin Gökcan: Tıbbi Müdahaleden Doğan Hukuki ve Cezai Sorumluluk, Ankara 2014.
Hakan Hakeri: Tıp Hukuku, 18. bası, Ankara 2020.

Cases and articles

Planned Learning Activities and Teaching Methods

Lecture, presentation, class discussion, homework

Assessment Methods

SORTING NUMBER SHORT CODE LONG CODE FORMULA
1 MTE MIDTERM EXAM
2 FCG FINAL COURSE GRADE
3 FCGR FINAL COURSE GRADE MTE * 0.40 + FCG* 0.60
4 RST RESIT
5 FCGR FINAL COURSE GRADE (RESIT) MTE * 0.40 + RST* 0.60


Further Notes About Assessment Methods

None

Assessment Criteria

To be announced

Language of Instruction

Turkish

Course Policies and Rules

To be announced

Contact Details for the Lecturer(s)

serdar.nart@deu.edu.tr

Office Hours

To be announced

Work Placement(s)

None

Workload Calculation

Activities Number Time (hours) Total Work Load (hours)
Lectures 13 3 39
Preparation about subject 13 3 39
Case study 8 2 16
Student Presentations 13 2 26
Individual homework preperation (CBIKO Talent Gate) 6 2 12
Preparing presentations 4 2 8
Midterm 1 2 2
Final 1 2 2
TOTAL WORKLOAD (hours) 144

Contribution of Learning Outcomes to Programme Outcomes

PO/LO
LO.1
LO.2
LO.3
LO.4
LO.5
LO.6
LO.7
LO.8

CONTACT INFORMATION
Dokuz Eylül Üniversitesi Cumhuriyet Bulvarı No: 144 35210 Alsancak / İZMİR
Phone: +90(232) 412 12 12 - Fax: +90 (232) 464 81 35

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