Choosing The Right Moment For Pre‑IND: Integrating US And EU Regulatory Pathways Into Your Strategy

The FDA Pre‑IND review is often approached as a regulatory checkpoint. However, for early‑stage biotechs, deciding when and how to make the most of this one-time meeting is a critical opportunity to define a robust regulatory strategy and development roadmap, reduce risk, and accelerate progression.

In this live panel discussion, hVIVO’s regulatory experts will explore how critical early decisions, such as modality classification (e.g., medicinal product, drug‑device combination product, or ATMP), shape regulatory pathways and influence development outcomes. The panel will highlight the importance of integrating non‑clinical, clinical, CMC and regulatory expertise early, alongside a strategic approach to engaging with global agencies such as the FDA and EMA, as well as national competent authorities including the MHRA, BfArM, and PEI.

Join us to learn how early regulatory planning can influence study design, support more efficient development, and maximize the value of scientific advice and Pre-IND meetings.

Attendees will learn:

• How early regulatory decisions shape development pathways
• Why product classification matters
• How strategic regulatory engagement can reduce risk and support development.
• What to consider when choosing a regulatory partner
• Rationale and timing for interactions with National Competent Authorities, the FDA, and/or the EMA

download Register now to attend

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