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International
Sponsor-CRO Relationships: A Legal View
Maria D. Buckley
Nutter, McLennen & Fish, LLP
Thursday,
March 27, 2008
11:30am to 12:30pm EST
Registration
fee US$249
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Register
for this Audio Conference
An
ever-present issue for sponsor companies is whether to partner
with a Clinical Research Organization. From that follows questions
and strategies on how to best select a CRO and manage the relationship.
The process takes on added dimension when conducting research
internationally. In
this presentation, the speaker will highlight key contract and
relationship issues and the recurrent problems that arise within
these relationships, and also offer practical, experience-based
tips for maximizing the relationship's value and efficiencies.
We will discuss the difference between partner and vendor, and
contract versus relationship. The presentation will also examine
local vs. U.S.-based CROs, and how to assess a CRO's experience
and ability to comply with local rules and regulations and FDA
requirements, as well as cooperating with the sponsor and other
participating CROs.
This
audio conference will cover:
- The limits
and potential of the CRO contracting process
- Recurrent
problems and tips on handling them
- EU Legal
Representative requirements and "Australian entity" requirements
- Using
one global CRO vs. a combination of local CROs
- How
and why compliance issues don't end at the U.S. borders
- Practical
issues such as time zones, language, currency, local insurance
and indemnification requirements, and whether the sponsor
or CRO should hold the contract with the OUS site
About
the speaker:
Maria
D. Buckley is Of Counsel and a member of the Healthcare and
Life Sciences practice groups with the Boston-based law firm
Nutter, McLennen & Fish. Maria has an extensive background in
healthcare law, health insurance, and managed care, with particular
emphasis on contracts, reimbursement, and regulatory interpretation
and compliance. Her clients have included hospitals, physician
practices, ancillary services providers, HMOs, and medical device,
pharmaceutical and biotech companies. She helps companies, institutions
and investigators document the clinical trials process. She
also regularly provides compliance advice and training with
respect to pharmaceutical sales and marketing activities, and
frequently speaks on various healthcare and research issues.
She has been active in providing pro bono legal service and
is a recipient of the Massachusetts Bar Association's Pro Bono
for Law Firms Award. Maria received a J.D. degree from Suffolk
University Law School, and a B.S. from Boston University. She
is an active member of the Health Law Section of the Boston
Bar Association.
Who should
attend?
- Attorneys
- Regulatory
Affairs
- Clinical
- Medical
Officers
- Scientific
Officers
- Business
Development
- Decision-makers
in clinical research operations for a pharmaceutical or biopharmaceutical
company
- CRO
Senior Management and Business Development.
Purchase
Options:
Please
note: Each
registration covers one line connected
to the audio conference. Attendees dialing from separate locations
are required to have separate registrations.
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