EPDB (EXPLORATORY PRODUCT DEVELOPMENT BRIEF) (DRW)

EPDB
full description of epdb
need of epdb
approach of epdb

1. Exploratory product development brief ( EPDB) PRITAM PATEL ( 25PG2300019) DEPARTMENT OF REGULATORY AFFAIRS (M-PHARM) DOCUMENTATION AND REGULATORY WRITING - (MRA-102T ) 1

2. Content INTRODUCTION Need of EPDB Brief of EPDB Aim of EPDB GOALS OF EPDB APPROACH Benefits ROLES IN DRUG DEVELOPMENT Applications Reference 2

3. Introduction : Product Development terminology is well known term but Exploratory product development is important in todays pharmaceutical Research and Development . The word “exploratory” is relating to or involving exploration or investigation. Exploratory product development brief (EPDB) is the first document that’s outline the main components of product development project . 3

4. Need of EPDB : Today , many business use some variation of the more than 50 year old phased and gated product developed and the sector . Results : overall speed of product development project is slowed down by many batches of a phased and gated system. Unable to manage scope, timetable and budget specified at the outset. 4

5. Brief of EPDB: Exploratory product development involves an exploratory research which is a type of market research that is conducted to gather the preliminary data about a potential new product. To generate the hypothesis Identify key issues Gather general information about the topics An exploratory product development model is a preliminary representation of a system or concept . 5

6. Aim: Its aims to investigate , clarify, or test the hypothesis about the behaviour , structure ,or relationship within the system. Change product specifications Unforeseen issue Rework scheduling delays Over budget Commercial outcomes 6

7. Exploratory research should be conducted at very beginning of the product development process It involve three stages of research : Exploratory research : conducted during ideation phase. Evaluative research : performed after ideas generation and explore specific issues that have emerged. Iterative research : Aimed at refining and enhancing features. 7

8. Goals of EPDB : The goal of this document is to clearly state the goals ,purpose, and scope of the project. Make well informed decision. Inclusion of components like risk assessment, resource requirements, market analysis and technical feasibility in brief. Create exploratory product development( ExPD ) which uses an adaptable framework to assist businesses to grow and increase product development success 8

9. Main objective of ExPD is to reduce uncertain risk by reducing the unknown errors in pharmaceuticals . Reduce risks Strategic planning. 9

10. Approach: The product development team requires a plan to adjust as per consumer needs, markets, competitive pressures and technical advancements . Define strategy Collect ideas and plan strategy Implement the product idea Explore,create and learn Launch product 10

11. Benefits of exploratory product development Early identification of users needs Informed decision making Enhanced creativity and innovation Risk mitigation Improved product development process Enhanced user satisfaction and engagement Competative advantage 11

12. Role of EPDB in drug development An Exploratory Product Development Brief (EPDB) plays a crucial role in the development of new drugs by enabling pharmaceutical companies to adapt quickly to changing environments, reducing uncertainty and risk. Role : Adaptive approach Risk management Integration with regulatory requirements 12

13. Adaptive Approach: EPDB allows teams to respond quickly to changes in customer needs, markets, competition, technology, and regulations. .- Risk Management: By identifying and prioritizing uncertainties, EPDB enables informed decision-making on project continuation or termination.- Integration with Regulatory Requirements: EPDB aligns with regulatory guidelines, ensuring compliance with good manufacturing practices (GMP) and other regulatory standards. 13

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15. Application in pharmaceutical industry : Drug Substance and Product Development: EPDB is applied to both drug substance and product development, ensuring a comprehensive approach to pharmaceutical development. Regulatory Compliance: EPDB aligns with regulatory requirements, facilitating the submission of new drug applications and ensuring compliance with GMP ³. 15

16. Reference : Pharmaceutical Distribution Security Alliance. PDMA compliance training module [Internet]. PDMA.org; [cited 2025 Oct 3]. Available from: https://www.pdma.org/store/ViewProduct.aspx?ID=10930950 Drotar D, Morrissey J. Exploratory product development: adaptable product development in a changing world. 2018 16

17. Thank You! 17