CRED 8 Presentations

01/07/2024

Influencing Factors: Internal & External Initiatives

Interactions with Regulatory Authorities • Range of advice that may be expected • Building on solid foundations •Understanding of regulators expectations • Importance of transparency • Appropriate level of interaction • Potential for HTA interactions, including parallel or joint advice

Emerging Regulatory Environment

Market Access Strategies

Company Portfolio

• Patient

• Regulatory science • Early access to medicines • Therapeutic developments • Opportunities for global trials • Regional trends • Emerging guidelines • Competitor products • Emerging safety concerns • Political dimensions

• Experience • Skills base • Positioning • Priority • Life cycle • Investor objectives

engagement • Payer Landscape • Key opinion leaders • Value messages • Health Technology Assessment (HTA) • Access & Reimbursement

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

9

9

Agenda

Regulatory strategy – what, why, when? Influencing factors, e.g. product type, strength of data, internal & external initiatives Scientific advice – where and how to obtain it Utilising internal and external expertise Integrating filing strategy with commercial objectives Final remarks

The Organisation for Professionals in Regulatory Affairs

09/07/2024

10

Developing your Global Filing Strategy – July 2024

10