TYPE OF COURSE UNIT	Elective Course
LEVEL OF COURSE UNIT	Bachelor's Degree
YEAR OF STUDY	-
SEMESTER	-
NUMBER OF ECTS CREDITS ALLOCATED	2
NAME OF LECTURER(S)	Professor Miyase Nilüfer Tarımcı Professor Fatma Nevin Çelebi
LEARNING OUTCOMES OF THE COURSE UNIT	At the end of this course, the students; 1) Learn the regulations about pharmacetical products, cosmetics and Medical Devices and learn the drug licensing procedures in Turkey, FDA and EMA 2) Learn the licensing procedures for human medicinal products, preparing licesing dossier in CTD formating, and special licensing conditions. 3) Learn the laws and regulations releated to cosmetics, cosmetic product decleration and product follow-up system 4) Learn the regulations releated to medical devices, clasifications of medical devices, production and approval procedures 5) Have knowledge about the ability to use the knowledge and skills gained in the advanced stages of education and to use them in professional life. 6) Acquire knowledge about duties, rights and responsibilities; and act ethically and in compliance with regulations as an individual.
MODE OF DELIVERY	Face to face
PRE-REQUISITES OF THE COURSE	No
RECOMMENDED OPTIONAL PROGRAMME COMPONENT	None
COURSE DEFINITION	The course covers the regulations related to drugs, cosmetic products and medical devices. It also covers licensing procedures of orijinal, generic and special drugs, rules and regulations regarding cosmetics, product follow-up system and specifications , area of use and regulations regarding Medical devices.
COURSE CONTENTS	WEEK TOPICS 1st Week Fundamental concepts regarding pharmaceutical products, cosmetics and medical devices 2nd Week Drug licensing procedures in TİTCK, FDA and EMA 3rd Week Preparing licensing dossier in CTD formating 4th Week Licensing application procedures for orijinal and generic drugs (shortened application) 5th Week Licensing applications on fast drugs and orphan drugs 6th Week Variations licensed products and products during the licensing process 7th Week ARA SINAV 8th Week Rules and regulations about cosmetics, cosmetic product decleration 9th Week Preparation of Product Information, Formulation Content and Finished Product dossiers, Product Tracking System 10th Week Legislation regarding cosmetic products containing nanomaterial ; market surveillance and audit 11th Week Medical Devices, basic definitions and their classifications 12th Week ClassI, ClassIIa, ClassIIb, ClassIII type Medical Devices, their properties, area of usage and legislation releated to them 13th Week Producer- seller- user duration in medical devices, production and confirmation process, Product Tracking System 14th Week Licensing procedures on Traditional Herbal Medicinal Products
RECOMENDED OR REQUIRED READING	1. Lecturer notes 2. www.saglikbakanligi.gov.tr 3. www.titck.gov.tr 4. www.fda.gov 4. www.ec.eurpa.eu 5. www.who.in/medical-devices
PLANNED LEARNING ACTIVITIES AND TEACHING METHODS	Lecture,Discussion
ASSESSMENT METHODS AND CRITERIA	Quantity Percentage(%) Mid-term 1 40 Total(%) 40 Contribution of In-term Studies to Overall Grade(%) 40 Contribution of Final Examination to Overall Grade(%) 60 Total(%) 100
ECTS WORKLOAD	Activities Number Hours Workload Midterm exam 1 2 2 Preparation for Quiz 0 0 0 Individual or group work 14 1 14 Preparation for Final exam 1 8 8 Course hours 14 2 28 Preparation for Midterm exam 1 6 6 Laboratory (including preparation) 0 0 0 Final exam 1 2 2 Homework 1 5 5 Total Workload 65 Total Workload / 30 2,16 ECTS Credits of the Course 2
LANGUAGE OF INSTRUCTION	Turkish
WORK PLACEMENT(S)	No