Learning Goal: I’m working on a global health project and need the explanation and answer to help me learn.
Overview
A key element of all Regulatory Affairs and related roles in a business is planning. This applies to product development, manufacturing, clinical, R&D, Operations, and so on. Planning is an actual requirement of Quality Management Systems for drugs, biologics, and devices, and the absence of plans for particular elements of a campaign, no matter what it is, can lead to deficiency findings during audits.
For part 1 of the assignments you will prepare a plan. This plan shall be prepared in the form of a Power Point Presentation that you would be presenting to executive management that is a summary of what the documented plan would contain. It should contain elements such as what regulatory requirements will need to be applied, including standards, what
technological characteristics will need to be applied and/or developed, resources (staffing, facilities, etc.) will be needed, and what a general timeline would be. This activity is basically a project plan typically prepared by project management with the aid
of the team in general.
From the selected topic (attached as pdf file) prepare a summary plan for what the requirements
are for preparing the submission you have selected. It should be professionally prepared and cited.
Specifics:
2- Prepare the overall strategy you will employ for your submission- base this on
what is required to be included (i.e. pre-clinical, clinical, design and development,
verification/validation, production, post-production)- this should be at least a few
paragraphs and can include visual aids (i.e. diagrams, tables, charts), use citations.
For this part you need to consult appropriate guidance documents and relevant
standards- if you need help with this, please reach out to me and we will set up
time to do so.
3- Create a roadmap to preparing the submission (first do this, then this, then this,
etc.)- this can be in form of a timeline or a descriptive paragraph or two.
4- Discuss challenges and means to overcome them and provide conclusions.
ASSIGNMENT: Answer and prepare write-up for Point-4 (Discuss challenges and means to overcome them and provide conclusion). The topic selected is BLA for PRIORIX.I have attached few files of it which you can refer at.It should be 1-2 pages and please provide references for it at the end.
