Unit 1- Product Life Cycle Management Flashcards
the length of time a product is introduced to consumers into the market until it’s removed from the shelves.
Product Life Cycle
Utilized by management and marketing professionals as a factor in deciding when it is appropriate to increase advertising, reduce prices, expand to new markets, or redesign packaging
Product Life Cycle
→ The process of strategizing ways to continuously support and maintain a product.
→ This refers to the handling of a good as it moves through the typical stages of its product life.
→ This handling involves both the manufacturing of the goods and the marketing of it.
PLCM (Product Life Cycle Management)
Helps inform business decision-making, from pricing, and promotion to expansion or cost-cutting.
Product Life Cycle
4 PHASES OF PLC:
Stage 1: Product Development/Introduction
Stage 2: Product Growth
Stage 3: Product Maturity
Stage 4: Product Decline
The product is losing market share or becoming obsolete. It is well past its point of highest demand and the demand decreases.
Stage 4: Product Decline
The product is widely available, and there are many competitors in the marketplace. You market the product to different segments, but more spending on advertising will have no impact on its demand.
Stage 3: Product Maturity
The product is more than an idea or a prototype.
The product is manufactured, marketed, and released.
Distribution increases, demand increases, and competition also increase.
Stage 2: Product Growth
The new product is introduced. This is when all the research and development happens.
Stage 1: Product Development/Introduction
How to Measure and Evaluate Your Product Life Cycle Management Program Signs to look into:
▪There are too many non-value add tasks
▪Your staff resumes some of their old practices
▪Not all the decisions are unanimous
▪Everything seems like it is urgent
▪Everyone is making decisions - there are no gates
▪You have bad data
Metrics for PLC Evaluation Innovation:
Innovation
Lead Time
Cycle Time
Product Life
Product Waste
Product Reliability
The total sales or revenue coming from new products.
Innovation
The time from order to delivery.
Lead Time
The time from production start to completion (including any testing).
Cycle Time:
The length of time the product is usable by the customer.
Product Life
The amount of waste per product produced.
Product Waste
The amount of your product found to be flawed or faulty within a period.
Product Reliability
Phase 1
Pharmaceutical Product Development
Phase 2
Production of pharmaceutical products
Phase 3
Market and sell of pharmaceutical products (Pharmacies, Hospital units)
Phase 4
Recycling of expired pharmaceutical products
Development
Clinical: Phase 1, 2 &3, Phase 4
Formulation
Delivery
Marketing Authorization
e CTD application
HA queries management
Labeling development and Launch plans
Post Approval commitment
Safety: PV, PSUR, safety update
Stability
Renewals
Variation Management
Site transfers
CMC changes
MAH transfer
New Indication
ICH Q12 - Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
• ICH Q12 Expert Working Group
Diversity of technical expertise (small and large molecule, development, manufacturing, quality and regulatory, assessors and inspectors)
• Good collaboration, team commits to address difficult topics
-Q12 EWG team members (current status):
o EU/EMA, EFPIA, Swissmedic, APIC, FDA, PhRMA, Health Canada, IGPA, BIO, MHLW/PMDA, JPMA, WHO, WSMI, DOH Chinese Taipei, DRA Singapore
Scope of the Q12 Guideline: All pharmaceutical products including currently marketed chemical, biotechnological and biological products
N/A
MAH
Marketing Authorisation Holder
Notification
A change to an approved established condition that does not require approval prior to implementation.
PACMP
Post-Approval Change Management Protocol
PLCM
Product Lifecycle Management
Post-approval CMC commitment
Commitment by the MAH to undertake specific CMC activities to be implemented during the commercial phase.
Prior approval
Change to an approved established condition that requires regulatory review and approval prior to implementation
PQR
Product Quality Review - regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements
PQR
Product Quality Review - regular periodic review of API or drug products with the objective to verify process consistency, to highlight any trends and to identify product and process improvements
QRM
Quality Risk Management
Submission
Communication to a regulatory authority regarding a change to an established condition that could be prior approval or notification.
