Why You Need to Take This Training Course?
Why You Need to Take This Training Course?
Why You Need to Take This Training Course?
This Course will Provide YOU with:
- Expert Guidance: Training courses led by experienced professionals from Upbeat Consult provide participants with expert guidance and insights into the complexities of bioequivalence studies. Experienced trainers can share practical knowledge, case studies, and industry best practices, enhancing the learning experience.
- Current Regulatory Insights: Given the dynamic nature of regulatory requirements in the pharmaceutical industry, a training course with Upbeat Consult offer up-to-date information on regulatory guidelines related to bioequivalence. Staying informed about the latest regulatory expectations is crucial for professionals in drug development and regulatory affairs.
- Practical Application and Case Studies: Courses that incorporate real-world case studies and practical applications provide participants with a more hands-on and applicable learning experience. This approach allows professionals to bridge theoretical knowledge with practical implementation, preparing them for challenges they may encounter in their roles.
What you'll learn
- Identify Key Components of a Clinical Study Report (CSR). Recognize the structure, format, and content of a CSR for a BE study as per ICH E3 guidelines.
- Interpret the Role of Each CSR Section. Learn how each section (e.g., study objectives, methodology, results, discussion) supports regulatory review and approval. Evaluate Study Design Elements in BE Studies
- Evaluate Study Design Elements in BE Studies. Review the critical design aspects of BE studies including crossover vs. parallel design, randomization, blinding, and washout periods.
- Assess Bioanalytical Method Validation. Understand the importance of validated analytical methods and the required documentation (Appendix 16.1.10) for regulatory compliance.
- Review Pharmacokinetic (PK) and Statistical Data. Interpret PK parameters (Cmax, AUC, Tmax) and statistical analyses used to demonstrate bioequivalence
- Analyze Safety and Tolerability Data Identify how adverse events, lab data, and dropouts are reported and discussed in BE studies.
- Review Common Deficiencies in BE Submissions: : Practice Critical Review Skills Learn about typical issues found during regulatory review and how to avoid them in CSR preparation.
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Interpret Appendices Required for Submission.
- Apply checklist-based and structured techniques to critically assess the completeness and compliance of a BE study CSR.
Instructor: Dr. Samer Sowidan
- Duration: 14 Hrs. Two days
- Time: 9.00 am- 4.00 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom & Virtual Training
- Price US $ 495
- Certificate Granted as Hard or Soft Copy
- Discount available for companies who send three or more participants
- Seats for this course: 12
- Virtual through zoom or google meet
- Classroom course at Upbeat office, hotel or at the customer premises
