Workshop Description
A phase III clinical trial represents 10 to 15 years of research and development investment, often exceeding $1 billion. Every submission to the FDA, EMA, or MHRA; every data-sharing agreement with a contract research organisation; every secure file transfer to an academic partner uses the same RSA and ECC encryption that Shor's algorithm will eventually break. Nation-state actors pursuing harvest-now-decrypt-later strategies do not need to decrypt pharmaceutical data today. They only need to collect it and wait. The World Economic Forum assessed in September 2025 that pharma and life sciences face a uniquely acute HNDL exposure because of long data lifecycles and the value of proprietary IP to foreign state-backed pharmaceutical programmes.
This workshop addresses the pharmaceutical and clinical research security problem as a distinct operational challenge, separate from the general healthcare cryptography migration. It covers the specific regulatory frameworks (21 CFR Part 11, EU Annex 11, GxP computerised system requirements) that govern clinical trial data integrity, and works through the multi-party supply chain problem: how do you impose PQC requirements on a CRO partner without contractual authority, and how do you sequence migration across a 40-vendor clinical data ecosystem? Participants leave with a data classification matrix for quantum risk, a supply chain assessment framework, and a board-ready IP exposure quantification model.
What participants cover
- Threat intelligence on pharmaceutical IP targeting: what nation-state HNDL campaigns look like against the life sciences sector
- Regulatory submission data exposure: NDA filings, EU CTR submissions, and the cryptographic security of data submitted to FDA and EMA
- CRO and academic partner supply chain: extending PQC requirements through multi-party clinical trial data-sharing arrangements
- Clinical trial data classification for quantum risk: which trial phases and data types carry the highest HNDL exposure
- GxP compliance and PQC: aligning post-quantum migration to 21 CFR Part 11, EU Annex 11, and MHRA computerised systems guidance
- Quantifying IP-at-risk for the pharma board: translating cryptographic exposure into financial terms