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ASTP Masterclass on Clinical Trial Agreements - 21 April 2009, Amsterdam

This one-day training course will discuss the main issues that arise in CTAs, from the perspective of the university or medical school. The focus of the course is on the terms that should be included in the agreement. The legal, regulatory and ethical framework for clinical trials (a huge subject in itself) will be discussed in the context of drafting and negotiating contract terms. Different types of CTA will be considered, including those for commercial or academic trials, single- or multi-centre trials, and special cases such as advanced therapies.

21 April 2009 - 21 April 2009
Austria
Topics to be covered will include:
• Who should be the parties to the CTA – pharmaceutical company, CRO, university, hospital, technology transfer company, principal investigator, medical staff?
• Work obligations and payment terms; back-to-back arrangements with other service providers
• Early termination and its consequences
• Defining and allocating responsibility, risk and liability, including insurance
• Academic priorities, including publications and intellectual property
• Handling difficult negotiation issues with pharmaceutical companies
• Regulatory issues, including approvals, consents, data protection and medical recordsPlease check the website of ASTP (http://www.astp.net(opens in new window)) for the complete programme and registration.
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