Thursday, July 22, 2010

Negotiating Clinical Trial Agreements for Sponsors: Don't just Trust Your Template

Does your clinical trial agreement protect your interests? Does it take into consideration the specifics of your current negotiations?

Trial agreements are unique, as they address issues of confidentiality, publication, IP rights, study data, indemnification, subject injury, insurance and more. And if you are using a template or "standard" trial agreement—even one that has worked in prior trials your company has sponsored—you may be exposing your company to legal liability.

In this 90 minute webinar, attorney Katherine Leibowitz will provide insight on writing and negotiating clinical trial agreements for drug and medical device sponsors that benefit you and your organization, while providing enough upside for the research site so that they sign.

After this program, you will know :

What really is "standard" in the standard clinical trial agreement, and how much of that is negotiable
Why you shouldn't sign the trial site's off-the-shelf agreement
Which parties should sign the clinical trial agreement - and what to do if they refuse
Risk-sharing and indemnification can be the stickiest wicket of all - here's how to protect your side while satisfying the other side
You want to keep all IP rights and confidentiality protection - the trial site needs publication rights; here's how to make both happy
How to ensure that you get the data access rights you need
How to build in an exit strategy - it is different here from standard service contracts
Practical guidance for negotiating with universities - what they care about and what might they give up

Katherine will also answer your team's questions in the Q&A session.

Who should attend...

Clinical and regulatory affairs
Risk management professionals
Corporate, general and outside counsel
Clinical trial managers
Research directors
Directors and executive management

For one low price, you and your entire team from one location can take part in this fast-paced, insightful webinar. Best of all, you'll be able to connect personally with our panelists when we open up the phone lines for live Q & A.

SPEAKERS

Katherine Leibowitz
Attorney
Hogan Lovells US LLP

Katherine represents companies in the life sciences field that are seeking to develop, test, and protect their technology both in the United States and internationally. She structures and negotiates agreements for multicenter clinical trials, contract research organization (CRO) services, core lab services, physician consulting, data safety monitoring board (DSMB) and clinical events committee (CEC) consulting, animal studies, supply, device sales and rental, and other documents for companies seeking regulatory approval for investigational devices. She regularly counsels companies on matters of general contract law, intellectual property ownership, and data access.

Katherine provides companies with a cross-disciplinary approach to transactions by addressing general contract law, intellectual property, FDA regulatory compliance, risk management, HIPAA, fraud and abuse, and foreign legal and regulatory compliance, often working with members of the Hogan Lovells US FDA regulatory practice, fraud and abuse group, HIPAA team, and the firm's foreign offices.

Katherine earned her J.D. from the University of Pennsylvania Law School.

Webinar Details

DATE: Thursday, July 22, 2010
TIME: 10:00 AM PT • 11:00 PM MT • 1:00 PM ET
DURATION: 90 Minutes

Benefits

What does registration get me?

One (1) phone line, for you alone, or around which to gather your team(s). Toll-free in the U.S. only.
One (1) password to a website on which you'll be taken through the presenters' slides as they speak to them.
An interactive Q&A round with speakers by phone and electronic submission.
The insight you've come to expect and respect from Elsevier Business Intelligence and our guest speakers.

What are the unique benefits of a webinar?

Convenience— and lower cost. Your entire team can listen in one room. No travel required!
A team approach. You've often wanted to have everyone on your team getting the same knowledge and insight you derive from physical conferences. Now you can.
Interactivity. You're remote, but not removed. Our webinars let you ask the important, burning, controversial questions of our speakers that you'd be able to pose at a physical conference.
Flexibility. Want to be able to review what you learn? No problem ... just register for the live webinar PLUS a digital copy of the entire event to listen to at your convenience. Interested in the topic but have a scheduling conflict? Don't worry—the recording is available for purchase at any time

SUPPORTING PUBLICATIONS

REGISTRATION

Buy the recording/transcript: Click here for just the recorded webinar with the complete transcript, $349
Register by email: custcare@elsevier.com
Register by phone: 1 (800) 332-2181 (U.S.) / +1 (908) 547-2159 (non- U.S.)

Webinar Cancellation Policy: No refunds or credits will be given one week prior to the scheduled webinar, or after the webinar presentation materials and access instructions have been sent to participants. In lieu of cancellation, you may substitute another delegate from your company as a replacement.