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October 2024
The National Pharmaceutical Regulatory Agency (NPRA), in collaboration with the Ministry of Health Malaysia, will host the Good Submission Practice Workshop for generic medicines on November 20-21, 2024, at Eastin Hotel Kuala Lumpur. This training event aims to equip participants with the necessary skills to submit high-quality dossiers to the NPRA. Topics include generic medicines applications, common deficiencies, regulatory requirements, submission quality, risk management, and practical case studies. The agenda includes registration, opening speeches, an overview of the application process, Q&A sessions, and discussions on variations and renewals. The workshop seeks to enhance submission quality and reduce queries and rejections.
Source: https://npra.gov.my/easyarticles/images/users/1106/GSP-2.0-Flyer-V3.pdf
Region: Malaysia
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