KPE-C-072 Fundamental Training on 505B(2) Application Submission
Posted on30 Mar 2018
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The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways. The pathway was... Read More
KPE-C-058 – KPE’s 1 Day Introductory Training in Drug Regulatory Affairs
Posted on15 Jun 2015
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Course Objectives: The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the interphase... Read More
KPE-C-055 KPE’s 1 Week Fundamental Training in Rx to OTC switch
Posted on16 May 2015
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Course Objective: Rx-to-OTC switch refers to the transfer of proven prescription drugs (Rx) to nonprescription, OTC status. Rx-to-OTC switch is a data-driven,... Read More
KPE-C-053 Fundamental Training on Drug Master File Preparation & Submission
Posted on09 May 2015
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Drug Master File summarizes the essential elements pertaining to facilities, processing, manufacturing components, packaging and storage for products associated with pharmaceutical product... Read More
