Regulatory strategy is most effective when it shapes development decisions early, not when it is applied as a submission readiness activity at the end. By the time a program is assembling its filing, the decisions that determine how smoothly that filing goes have already been made, often by people who were not thinking about them as regulatory decisions at all.
This presentation introduces the regulatory moat: an integrated framework that protects drug, device, and combination product programs from internal risks such as fragmented decisions, unclear ownership, incomplete evidence plans, supplier interface gaps, and misaligned timelines.
The term is deliberate. A moat is built before it is needed, it surrounds the whole structure rather than one wall, and its value only becomes visible when something tries to cross it. Most programs do not fail at the agency. They fail internally first, in the quiet gaps between functions, and the agency simply reports back what was already true.
Combination products make this sharper than any other category. A single product can sit across two regulatory frameworks, two sets of quality expectations, and two cultures of evidence. Design controls and pharmaceutical development run on different assumptions about when a specification becomes fixed. Device suppliers and drug substance suppliers are qualified under different logic. Lead center determination shapes the submission pathway but is often settled long after decisions that depend on it. Each of these is manageable on its own and compounding when left to resolve itself.
The session works through where those risks originate and how an integrated regulatory strategy addresses them before they become findings, delays, or rework.
What you will take away
- How to position regulatory strategy as a development input rather than a downstream deliverable
- Where decision ownership typically breaks down across drug, device, and combination product programs, and how to establish it explicitly
- How supplier and partner interfaces create regulatory exposure, and what to specify up front
- How to align regulatory, clinical, quality, and manufacturing timelines so one function's milestone is not another's surprise
Who should attend
Regulatory affairs, quality, clinical, and program leadership working on drug, device, or combination products, from early development through submission. The material is most useful to those making or influencing decisions before a filing strategy is locked, and to anyone who has inherited a program where those decisions were made without them.
Speakers
Jerzy Wojcik
Sponsors
