MOPI Training 2024: Good Submission Practice 2.0 for Generic Medicines

The objective of a Good Submission Practice Workshop for generic medicines is to prepare the applicant to submit Good Quality Dossiers to National Pharmaceutical Regulatory Agency (NPRA). By the end of the workshop, participants should be more competent and equipped to navigate the complexities of regulatory submissions.

Learning Objectives

a) Understanding Regulatory Requirements: Familiarize participants with the relevant guidelines and regulations for pharmaceutical products.

b) Enhancing Submission Quality: To improve the clarity, accuracy, and completeness of submissions to reduce the likelihood of queries or rejections. To address challenges face during registration submission.

c) Risk Management: Discuss potential pitfalls in the submission process and how to mitigate risks through proactive planning and quality checks.

d) Case Studies: Provide case studies or examples of successful submissions and common mistakes, allowing participants to learn from practical scenarios.

Who Should Attend?

• Regulatory Affairs Executive

• Regulatory Affairs Managers

• Personnel involved in dossier preparation