Programme Masterclass Clinical Trial Agreements 23 March 2012, Schiphol airport, Amsterdam Mark Anderson
9.30
Registration and coffee Private reading of sample agreements and other course papers
10.00
Introduction to CTAs; issues that frequently arise in negotiations
10.15 Legal, regulatory and ethical issues affecting CTAs – an overview Including: approvals to conduct trials, consents, compliance with GMP & GCP, insurance requirements, data protection, other relevant laws and policies 11.15 Coffee 11.30 Legal clauses in CTAs Including: warranties, liability, indemnities and insurance, law and jurisdiction, comparison of jurisdictions 12.15 Group drafting exercises 12.45 Discussion of answers to exercises 13.00 Lunch 13.45 Review of some standard agreements, documents and forms used in clinical trials Including: consent forms, protocols, case report forms, standard CTAs, etc 14.15 Clause-by-clause review of some CTAs Including: parties, work, payment, reporting, confidentiality and publications, intellectual property, regulatory compliance, termination and its consequences Academic and institutional priorities; sponsor needs; negotiating issues 15.15 Tea break 15.30 Clause-by-clause review, continued 16.30 Finish