CRED 8 Presentations

01/07/2024

Scientific Advice – Where and How to Obtain It

Advice is an integral part of the drug development process

• Agencies participating in ICH generally provide opportunity to gain “advice” • Key role of regulators is the protection of public health which includes support for innovation • HTA advice from multiple archetypes, opportunities for joint or parallel advice

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

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Scientific Advice From a Sponsor’s Perspective

New medicines are usually intended for a global market • The US remains the largest single market • Impact on global trials • Long development times are associated with significant commercial risk Diverse sources of advice are available and are often not consistent • National agencies • US, Japan, European, China, Other Agencies • EU Scientific Advice • Health technology assessment

• Parallel/joint advice –MHRA/NICE, HTA/EMA, HTA networks Consider diagnostic co-development and HTA input

The Organisation for Professionals in Regulatory Affairs

09/07/2024

Developing your Global Filing Strategy – July 2024

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