| Contract & Budgets| MONDAY, FEBRUARY 25th:PRE-CONFERENCE SYMPOSIUMS | | | | | |
| 2: Structuring the Deal: Contracts, Budgets & Negotiations | | 11:00 | Increasing Efficiencies and Minimizing Risk When Developing the Deal Learn how to structure key provisions in clinical contracts and budgets, as well as the pros and cons of various approaches Draft provisions which help minimize risk, learn the most common points of negotiations and how to get what you want, and how to use master contracts and variables to increase efficiencies. Leigh-Ann M. Durant, Associate General Counsel of Clinical Trials and Medical Affairs, EMD SERONO, INC | | | | 11:40 | Conduct Clinical Trial Budget & Contract Risk Assessments to Avoid Scrutiny from the Three Letter Enforcement Agencies The Federal Government's enforcement agencies are focusing more and more on clinical trial budgets and contracts. Is your company at risk? This session provides an overview of current clinical trial budget and contract compliance issues, reviews major CT budget and contract risks for sponsors, discusses potential penalties and sanctions for sponsor noncompliance and reviews ways for sponsors to decrease audit findings that lead to kickback, false claims and fraud accusations. Ian C. Lauf, Manager, Manager, Contracts & Outsourcing, PFIZER | | | | 12:20 | Luncheon for Symposia Attendees | | | | 1:40 | Contract Terms: What's Important from a Sponsor Perspective Rapid study start up is critical to any clinical trial. To speed up contract negotiations and negotiate a win-win deal, it is beneficial to understand the other party's perspective. This presentation covers those areas that are most important to a Sponsor and the driving forces behind a Sponsor's position. This includes inventions, publications, confidentiality, as well as other standard terms. Pam Schroeder, Paralegal Supervisor,ABBOTT LABORATORIES | | |
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