Module 5 Presentations

19/07/2024

Assessment of quantum: clinical trial claims

• In England damages are intended to provide recompense for loss and damage suffered • Basis for assessment – General damages for pain, suffering and loss of amenity – Special damages in respect of expenses incurred (medical costs, travel expenses, loss of earnings, cost of care) – Future consequential financial loss (particularly future loss of earnings and cost of care)

NB: Social Security benefits and NHS costs may have to be reimbursed

The Organisation for Professionals in Regulatory Affairs

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Case Study 1 (1)

• Te Genero: Northwick Park Trial – Sponsor: small German company funded through venture capital – CTA approved by German and UK authorities – IMP manufactured by third party company outside UK – First in man studies of novel biologic product held in UK – Study conducted by CRO

The Organisation for Professionals in Regulatory Affairs

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