Beginning of pharmacy practice

Prepare By:
Abdullah Alharbi 150036
Eyad Basodan 140174
Fahad Alshammari 150273

Under supervision of
Dr / Noha Eldin

PH-1 / Second Semester

2020-2021
 STUDENT ASSIGNMENT COVER SHEET

Academic Year ___1_____

Semester ______2________

Program: ___pharmacy_______________________________

Student Name: ___ Abdullah Alharbi ______________________________

Student ID Number: _____150036_________________________________

Program Year/Level: __ph1_________________________________

Course/Code: _____________________________________________

Instructor Name: ___Dr.noha eldin___________________________________

Assignment Title: ____ Saudi FDA ____________________________________

Deadline Date: ___15/2/2021___________________________________

Date of Actual Submission: ___15/2/2021___________________________________

Student Agreement:

I understand if my assignment is late, that 10% of the total assignment grade will be deducted if submitted anytime
within the five academic days following the due date. Later than this, I understand that I will receive a zero on the
assignment.

Student Signature: _____________________________________________

Instructor Signature: ____________________________________________

1. This cover sheet must be attached to the assignment.

2. Written assignments are to be submitted in soft copies (electronic) in Word.
 STUDENT ASSIGNMENT COVER SHEET

Academic Year ___1_____

Semester ______2________

Program: ___pharmacy_______________________________

Student Name: ___ Eyad Basodan ______________________________

Student ID Number: _____140174_________________________________

Program Year/Level: __ph1_________________________________

Course/Code: _____________________________________________

Instructor Name: ___Dr.noha eldin___________________________________

Assignment Title: ____ Saudi FDA ____________________________________

Deadline Date: __ 15/2/2021___________________________________

Date of Actual Submission: ___15/2/2021___________________________________

Student Agreement:

I understand if my assignment is late, that 10% of the total assignment grade will be deducted if submitted anytime
within the five academic days following the due date. Later than this, I understand that I will receive a zero on the
assignment.

Student Signature: _____________________________________________

Instructor Signature: ____________________________________________

1. This cover sheet must be attached to the assignment.

2. Written assignments are to be submitted in soft copies (electronic) in Word.
 STUDENT ASSIGNMENT COVER SHEET

Academic Year ___1_____

Semester ______2________

Program: ___pharmacy_______________________________

Student Name: ___ Fahad Alshammari ______________________________

Student ID Number: _____150273_________________________________

Program Year/Level: __ph1_________________________________

Course/Code: _____________________________________________

Instructor Name: ___Dr.noha eldin___________________________________

Assignment Title: ____ Saudi FDA ____________________________________

Deadline Date: ___15/2/2021___________________________________

Date of Actual Submission: ___15/2/2021___________________________________

Student Agreement:

I understand if my assignment is late, that 10% of the total assignment grade will be deducted if submitted anytime
within the five academic days following the due date. Later than this, I understand that I will receive a zero on the
assignment.

Student Signature: _____________________________________________

Instructor Signature: ____________________________________________

1. This cover sheet must be attached to the assignment.

2. Written assignments are to be submitted in soft cop
1-State the Resources that are found on SFDA Site for the medications?

Communication via the unified number(19999).

2-Do the SFDA provide a list of the medications that are suffering from
shortage in KSA, and when this list do you think should be updated?

Yes, it does . The list must be updated daily.

3-What are the E Services provided by the SFDA for the medications?

Grant drug marketing licenses. Ensure that medicinal plants, health products and
herbal products are healthy. Perform medication quality controls in the market and
post-marketing of medicines. Ensuring the protection of cosmetic products and
supplying public or healthcare providers who need such information with
medication information from a reliable source

4-What is the Drug Identity Service found on SFDA for medications?

It enables identification of identical drug alternatives, active ingredient,

concentration, quality and safety with different prices and manufacturer.

5-Can you register to be a consultant at SFDA?

Yes, you can.

6- Where is the SFDA allocated and how can you contact them?

In Jeddah, Hail Street. Communication via the unified number(19999).

7-How can the community report any issue to SFDA?

By sending a report to (NCMDR)

8-What is the difference between the product withdrawal and the product
recall?

Product withdrawals and recalls as a result of a food incident, a food product may
have to be withdrawn or recalled.  A withdrawal is when, before it has reached
customers, unhealthy food is withdrawn from the supply chain.  When unsafe food
is removed from the supply chain and customers are urged to take reasonable
actions, such as returning or disposing of unsafe food, a reminder is provided.
9-Should any healthcare/medical software have the legalization to be used as
KSA or the GCC?

Yes, it should.

10- When is the medical software considered as a medical device?

The International Medical Device Regulators Forum (IMDRF) defines the word
Software as a Medical Device Cas' software intended to be used for one or more
medical purposes without being part of a hardware medical device. 'The use of
Software as a Medical Device continues to increase. It can be used across a wide
variety of technology platforms, including medical Such software was formerly
referred to as "standalone software," "medical device software," and / or "health
software," by industry, international authorities, and health care providers. , and can
often be confused with other forms of software.