Activity TitleAdvanced Course in Bioequivalence BE In-Depth BE Study Requirements for SFDA Compliance
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Location
Bana Medical Company - Riyadh
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Phone
+966 532375500
- Website: www.mesned.com Join Event
- Email Address: training@mesned.com
- Email Activity Coordinator: training@mesned.com
- Phone Activity Coordinator: +966 564279653
Event Audience
- Pharmaceutical Sciences
- Pharmaceutical administration AND outcomes
- Pharmacy
Event Goals
- 1. Compare and contrast various BE study designs (parallel, crossover, replicate) and select the most appropriate design for different drug types within two days of training, as assessed through case study discussions.
- 2. Identify key considerations in analytical techniques used in BE studies and demonstrate understanding by correctly answering at least 80% of assessment questions by the end of the course.
- 3. Apply Saudi FDA guidelines to the design and evaluation of BE studies for NTI drugs, highly variable drugs, and modified release products, as demonstrated through hands-on case studies completed within the training period.
- 4. Assess dissolution profile similarity according to Saudi FDA regulatory requirements, successfully interpreting at least two dissolution profile datasets in practical exercises by the end of the second day.
- 5. Explain the BCS and determine eligibility for BCS-based biowaivers under Saudi FDA guidelines, as assessed through case study discussions.
- 6. Analyze BE requirements for complex generic products, including formulation challenges and regulatory expectations, by successfully completing a group case study within the course duration.
- 7. Prepare a regulatory-compliant BE study report for submission to the Saudi FDA, demonstrating proficiency by identifying and correcting at least three common deficiencies in sample reports provided during training.
- 8. Recognize emerging trends in BE evaluation, including alternative methodologies and regulatory advancements, and provide at least one example of an innovation in BE assessment during the final discussion session.
Event Agenda
14/05/2025
registartion
08:30:00 - 09:00:00
Speaker(s):
No speakers assigned
14/05/2025
Overview of the bioequivalence (BE) study designs: Parallel, crossover, and replicate
09:00:00 - 10:15:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Discussion
10:15:00 - 10:30:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
break
10:30:00 - 10:40:00
Speaker(s):
No speakers assigned
14/05/2025
Key considerations in conduction of the bioequivalence study and analytical methods
10:40:00 - 11:45:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Saudi FDA requirements for: Narrow Therapeutic Index drugs, Highly Variable Drugs, & Modified Release Products
11:45:00 - 13:00:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Discussion, Q and A
13:00:00 - 13:15:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
lunch
13:15:00 - 14:00:00
Speaker(s):
No speakers assigned
14/05/2025
Dissolution testing and the similarity of dissolution profiles of the BE (Bioequivalence) study
14:00:00 - 15:00:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Discussion
15:00:00 - 15:10:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Biopharmaceutical Classification System (BCS) and its application in Bioequivalence (BE) waivers
15:10:00 - 16:15:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
break
16:15:00 - 16:30:00
Speaker(s):
No speakers assigned
14/05/2025
Criteria for Biopharmaceutical Classification System (BCS)-based biowaivers according to Saudi FDA guidelines
16:30:00 - 17:40:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
14/05/2025
Discussion
17:40:00 - 18:10:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Complex generic products: Types and examples
09:00:00 - 10:30:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Bioequivalence Saudi FDA requirements for complex generic products
10:30:00 - 11:45:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Discussion
11:45:00 - 12:00:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
break
12:00:00 - 12:15:00
Speaker(s):
No speakers assigned
15/05/2025
Preparing a bioequivalence study report for submission to the Saudi Food & Drug Authority SFDA
12:15:00 - 13:30:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Discussion
13:30:00 - 13:45:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
lunch
13:45:00 - 14:30:00
Speaker(s):
No speakers assigned
15/05/2025
Common Saudi Food & Drug Authority (SFDA) deficiencies and how to avoid these deficiencies
14:30:00 - 15:30:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Q&A
15:30:00 - 15:45:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Future trends in bioequivalence studies
15:45:00 - 17:10:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Discussion
17:10:00 - 17:30:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
15/05/2025
Conclusion & certification
17:30:00 - 18:00:00
Speaker(s):
زياد سعود بن خثلان (ZIYAD SAUD BINKHATHLAN)
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