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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 and biowaiver 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 and biowaiver studies. 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
- Participantes will understand the principles of bioequivalence. They will gain a comprehensive understanding of the fundamental concepts and principles related to bioequivalence studies, including the factors influencing drug absorption, distribution, metabolism, and excretion (ADME).
- Participants will learn how to navigate regulatory guidelines. They will be familiar with the specific guidelines and requirements set forth by regulatory agencies governing bioequivalence studies. This includes an in-depth exploration of current regulatory expectations and updates.
- Participants will know when to apply biowaiver criteria. They will acquire knowledge about biowaiver studies, including criteria for their application. Understand the circumstances under which a biowaiver may be considered and the regulatory considerations associated with this approach
- Participants will evaluate analytical methods and quality control. They will explore various bioanalytical methods used in bioequivalence studies and understand the principles of method validation. Emphasize the importance of quality control measures, adherence to Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
Instructor: Dr. Samer Sowidan
- Duration: 12 Hrs. one days
- Time: 9.00 am- 3.00 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom or Vitual Training
- Price US $ 355
- Certificate of completion is provided
- 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
