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Korea Biomedicine Industry Association
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Training for Manufacturing & Import Managers

Program Overview

Relevant Regulations

  • - Pharmaceutical Affairs Act: Article 37-2, Article 42
  • - Regulation on Safety of Pharmaceuticals, etc.: Articles 44, 45, and 60

Training Duration & Requirements

  • Must complete at least 16 hours of training every 2 years. ※Failure to complete the required 16 hours of training within a two-year cycle will result in an administrative fine of KRW 500,000, in accordance with Article 98 of the Pharmaceutical Affairs Act and Article 39 [Annex 3] of its Enforcement Decree.

Target Audience

  • - Manufacturing Managers: Pursuant to Article 36 of the Pharmaceutical Affairs Act and Article 42 of the Regulation on Safety of Pharmaceuticals, etc.
  • - Import Managers: Pursuant to Article 42 (5) of the Pharmaceutical Affairs Act and Article 58 of the Regulation on Safety of Pharmaceuticals, etc.

Training Objectives

  • 01 Ensuring the safety and efficacy of pharmaceuticals and related products
  • 02 Preventing risks to public health

Curriculum

  • Matters related to ensuring the safety and efficacy
    of pharmaceuticals
  • Matters related to the manufacturing and quality control (GMP)
    of pharmaceuticals and related products
  • Matters related to the latest scientific and technological advancements
    in the pharmaceutical industry
  • Matters related to the Pharmaceutical Affairs Act and other relevant regulations

KoBIA operates training programs for Manufacturing and Import Managers twice a year (first and second half). We also provide specialized courses tailored for biopharmaceutical managers.

※ For more details, please visit the registration page.

Go to Training Registration