Good Submission Practice Workshop for Generic Medicines

Hosted by the National Pharmaceutical Regulatory Agency (NPRA)
Dates: November 20-21, 2024
Location: Eastin Hotel Kuala Lumpur

The NPRA, in partnership with the Ministry of Health Malaysia, is organizing a comprehensive Good Submission Practice Workshop tailored for professionals involved in generic medicines applications. This hands-on event is designed to equip participants with the knowledge and tools needed to prepare high-quality dossiers for successful submission to the NPRA.

Workshop Highlights:
Core Topics:

Application Process for Generic Medicines: Step-by-step guidance on submitting dossiers.
Common Deficiencies: Identification of frequent submission errors.
Regulatory Requirements: Key regulatory guidelines for generic medicines.
Submission Quality: Strategies to enhance submission accuracy.
Risk Management: Addressing risks associated with dossier submissions.
Case Studies: Practical examples and analysis of real-world cases.
Agenda Overview:

Registration: Participant check-in.
Opening Speeches: Remarks by NPRA and Ministry of Health officials.
Application Process Overview: Detailed walkthrough of application steps.
Interactive Q&A Sessions: Open forum for addressing participant queries.
Discussions on Variations and Renewals: Guidance on managing changes and maintaining compliance.
Workshop Objectives:
Enhance Submission Quality: Reducing common submission issues to improve the approval rate.
Reduce Queries and Rejections: Streamlining the application process to minimize follow-up queries.
The workshop provides a unique opportunity for attendees to engage with experts, discuss best practices, and gain practical insights to optimize their submissions to the NPRA.

Source: https://npra.gov.my/easyarticles/images/users/1106/GSP-2.0-Flyer-V3.pdf

Region:  Malaysia