CRED ERP 25

02/07/2025

General considerations

Demand Patients & medical need

Product

Internal environment

External environment

• Demographics • Disease prevalence • Seriousness and severity • Disease progression • Diagnosis and treatment pathway + guidelines • Precedent • Quality of Life • Patient registries • Patient advocacy groups

• Technology • Administration method • Product centric vs platform • Innovative vs generic • Orphan products • Therapeutic area • Applicable regulatory frameworks • Data strengths and weaknesses • Prioritisation • Positioning • Manufacturing and supply

• Vision, mission and values • Corporate objectives • Governance • Systems and infrastructure

• Socio-economic-political environment • Interactions with Regulatory Agencies • Emerging regulatory environment • Market Access • Competitors • Patent expirations and generic competition

• Expertise • Resources • Company portfolio

Associated/co-developed products

The Organisation for Professionals in Regulatory Affairs

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External considerations

Socio-economic-political environment

Interactions with Regulatory Agencies

Emerging regulatory environment

Market Access

• Appropriate expertise • Resources • Reliability and consistency of regulatory procedures • Range of advice available • Accelerated regulatory mechanisms •Understanding regulators’ expectations • Transparency • Data/market exclusivity/ protection • Potential for HTA interactions

• Grants and funding • Government healthcare initiatives • Commercial attractiveness • Educational and research programs and initiatives • Data protection and security • Political agendas

• Early access to medicines • Global (decentralized) clinical trials • Emerging guidelines & standards • Regulatory reforms • Therapeutic developments • Regional trends • Competitor products • Emerging safety concerns • Converging multiple legislative systems

• Patient engagement • Payor landscape • Key opinion leaders • Value messages

• Health Technology Assessment (HTA) • Access and Reimbursement • Readiness of healthcare systems to adopt new technology • Real world data (RWD) and real world evidence (RWE)

The Organisation for Professionals in Regulatory Affairs

12

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