1
specifications Course
University : Minia Faculty : Pharmacy Department: Pharmaceutics
1- Administrative Information Course Title:
Pharmaceutical legislation
Code: PT 304 Academic Year/level:
4th semester Department(s) offering the
course : Pharmaceutics
Lecture :
1hrs/week ( x12 week= 12 hrs/ semester)Tutorial :
0Practical :
0Total :
12 hr/year2- Aims (Module purpose) Pharmaceutical legislation generally provided for the educational qualification which the students must need after graduation at the time of registration and during pharmacy practice.
3- Intended Learning Outcomes of Course(ILOs)
a-Knowledge and Understanding:
At the end of this course learning, the students will have comprehensive knowledge and understanding of;
1. Principles of pharmaceutical science as well as pharmacy practice.
2. The relevant laws, ethics and codes of practice in community and industry, its impact on relationship with patients and other healthcare professionals.
B- General and Transferable Skills:
The students after graduation will be able to :
1. -Perform according to professional and moral ethical codes in a variety of legal situations.
2. Time management skills.
2
4- Course Contents:
Matrix I- Coverage of the course
PT 304by different topics
general and -
D
s
transferable skill C- Professional and
practical skills:
B- Intellectual skills:
Knowledge -
A and Understanding
Topics
C2 D1 B4 C1
B3 B2 B1 A2 A1
●
Law of pharmacy ●
practice
●
●
Legal sanitary requirements for pharm.organizations establishment
●
●
Drug abuse prevention and control Act
Lecture (1 hr) No of
hours Topic
2 Law of pharmacy practice 2
1 Legal sanitary requirements for 1
pharm.organizations establishment
2 Drug abuse prevention and 2
control Act
1 Penalities 1
1 Ministerial regulations 1
1 Legal requirements for OTC 1
products
1 1
Pharmaceutical representative offices
1 Syndicate of pharmacists 1
1 Other medical and pharmaceutical 1
organizations
1 Code of ethics 1
12
Total hours 12
3
●
● ●
Penalities
● ●
Ministerial regulations
●
Legal requirements for OTC
products
●
●
Pharmaceutical representative offices
● ●
Syndicate of pharmacists
●
●
Other medical and pharmaceutical organizations
● ●
Code of ethics
Law of pharmacy ●
practice
●
Legal sanitary requirements for pharm.organizations establishment
Matrix II- Coverage of the course
PT 304by different learning methods
s
general and transferable skill -
C- Professional and D practical skills:
B- Intellectual skills:
- A Knowledge
and Understandi
ng
Topics
D1 C2
C1 B4
B3 B2 B1 A2 A1
● lectures ●
6- Teaching and Learning Methods: to Students with Limited Capacity
There is no current methods used for student with limited capacity
7- Student Assessment:
a-Student Assessment Methods:
7.1 Written Exam. to assess understanding and intellectual skills.
5- Teaching and Learning Methods:
Lectures
4 b- Student Assessment Schedule
No Assessment Week
1 Final examination 16th
c- Weighting of Assessments
N0 Exam Mark %
1 Final Term
examination
50 100
Total 50 100
Matrix III- Measuring the achievement of the course
PT 304by different assessment methods
s
general and transferable skill -
C- Professional and D practical skills:
B- Intellectual skills:
- A Knowledge
and Understandi
ng
Topics
D1 C2
C1 B4
B3 B2 B1 A2 A1
● Written ●
- List of References:
A- Course Notes Consist of collections of pharmaceutical legislation, code of ethics, ministerial decisions,….etc applied in Egypt for pharmacy practice by pharmacists practicing in Egypt B- Essential Books: 1.Pharmacy practice and the law, Third Edn., Jones and
Bartlett publishers, Inc., Boston, USA, 2004
2.Remingtons, The science and practice of pharmacy, 20th Edn., published by Philadelphia college of pharmacy and science, Philadelphia, USA, 2000
C- Recommended Books: 1. Modern pharmaceutics, Third Edn., G.S. Banker and Ch.
T. Rhodes, Marcel Dekker, Inc., New York, USA, 1996 2. Textbook of Non-prescription drugs. American Pharmaceutical Association
D- Periodicals, Web sites, etc.
1.Journal of pharmacy and medicine, Egyptian Pharmaceutical Syndicate
2.Up to date regulations
Course Coordinator: Head of Department:
Prof.Dr. Aml Kamal Hussein Prof.Dr. Osama Farghaly Ali