BA/BE studies are required by regulators to ensure therapeutic equivalence between a pharmaceutically equivalent test product and a reference product. BE studies are done for early and late clinical trial formulations, formulations used in clinical trial and stability studies, if different Clinical trial formulations and to-be-marketed drug product.
This program covers types of BA/BE studies, Regulations, need of BE studies-NCEs & Generic Drugs, Analysis, Managing and Reporting of BE studies. Program would help you if you are planning to work in bio equivalence centres/CROs, or already working in the industry to obtain learn from experts and receive formal certification.
Live Sessions by BA/ BE Experts – Zoom / Teams / GoogleMeet
Access to Course Content – 24x7 LMS – Presentations, Notes, Modules & Session
Online exams in MCQ format
ACCRE USA Accredited Certification
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