Drug Product registration process in the US MasterClass

The process of registering a pharmaceutical product for marketing in the USA involves several steps and several critical points to focus on.
 

16-19 September, 2024, Virtual
Starting time – EDT 10:00 a.m. | PDT 07:00 a.m. | UTC 14:00 p.m. | CEST 16:00 p.m.

Overview

 The process of registering a pharmaceutical product for marketing in the USA involves several steps and several critical points to focus on. The flow that the process must follow depends on the type of registration requested, as established by the FDA (Food and Drug Administration), responsible body for the oversight of quality and safety of all foods and medicines distributed in the USA. The purpose of this Master Class is to clarify the registration processes prescribed by the FDA, so to understand what information, documents, evidence must be available and how these should be presented or explained to the authorities. The course will be structured through a logical sequence of steps:

• Initial understanding of what the FDA is and how the entity is organized
• Understand the classification process applicable to a presentation and the relevant evaluation process
• Management of special cases and understanding of any shortened processes

The second part of the Master Class will focus on the Audit, i.e. the direct verification by the FDA of the company’s information and working methods, presenting the different inspection types. We will discuss how to define a correct readiness plan and which fundamental steps must be included, starting from the assessment of the current state up to the resolution of all identified gaps, the definition of the audit logistics, the organization of dedicated spaces, the assignment of responsibilities to team members, the right behaviors to observe during the audit period, how to establish good interaction with the Inspectors. The final section will focus on the conclusion of the Audit and what to expect in terms of possible outcomes, how to work at the preparation of the answer to the observations to respond comprehensively within the time allowed with the good satisfaction of the Agency request and the Company needing.

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RECOMMENDATION

Who should attend?

• Quality Control
• Quality Assurance
• Manufacturing
• Engineering
• IT
• CSV
• Regulatory Affairs
• TR&D