Page 31 - Mansoura National University

Pharmacy Legislation and Practice Ethics Course – Level 2

“Pharmaceutical Registration in Practice: Engaging Students in Regulatory

and Quality Assurance Processes”

nd
For the 2 consecutive year, the Faculty of Pharmacy organized the “FDA Simulation Workshop
& Drug Registration Procedures”, providing students with hands-on training in the regulatory
requirements and documentation needed for pharmaceutical product approval.

Overview:

Continuing the activity carried out by the students in the course of Pharmaceutical Dosage Forms I
for the preparation of a certain dosage form, students simulated the pharmaceutical registration
process, mirroring the procedures of the Egyptian Drug Authority (EDA). They were divided into
groups of ten, then they prepared comprehensive registration file for the pharmaceutical preparation,
ensuring all regulatory requirements were met. Through role-playing, students presented their files
to a mock EDA panel, enhancing their understanding of regulatory scrutiny. The activity included
performing essential quality tests, such as drug content, pH measurements, and stability testing to
validate the preparation’s compliance.

Project Objectives:

• Understanding Regulatory Requirements: To familiarize students with the regulatory
requirements for pharmaceutical products, ensuring they understand the importance of
compliance.
• Hands-On Experience: Providing practical experience in preparing registration files and
performing quality tests, bridging the gap between theory and practice.
• Teamwork and Collaboration: Enhancement of teamwork and collaboration skills by working
in groups, simulating real-world pharmaceutical industry scenarios.
• Critical Thinking: To develop critical thinking skills by analyzing and solving problems related
to pharmaceutical registration and quality control.

• Communication Skills: Improvement of communication skills through role play and
presentations, essential for professional interactions in the industry.

• Understanding Quality Control: Emphasizing the importance of quality control in
pharmaceutical preparations, ensuring product safety and efficacy.
• Simulating Real-World Processes: Simulating the real-world processes of the EDA, providing a
realistic understanding of regulatory procedures.
• Ethical and Professional Standards: To instill ethical and professional standards in students,
highlighting the importance of integrity in pharmaceutical practices.

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