Selecting and Managing CROs
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Who Should Attend
This course is specifically designed for personnel in the
pharmaceutical, biotechnology and related industries who use
contract research organizations (CROs) for the discovery and
development of new drugs, devices, and biologics.
This includes, but is not limited to:-
Scientists
- Managers
- Project Team Leaders
Participants should have some experience in the processes
involved in new product submissions.
Description
The content of this course will assist pharmaceutical and
biotechnology researchers and managers and their
counterparts in the CRO industry in understanding the
requirements for a well-designed and successful outsourcing
program that is completed on time, within budget, and in
compliance with FDA regulations and ICH guidelines. The
types of CROs and the various outsourcing requirements will
be presented to assist in designing the sponsor-generated
outsourcing program. Proposal solicitation and evaluation, site
visits, contract negotiations, and other items necessary for
identifying and selecting a CRO will be discussed. Research
study planning, monitoring, problem assessment and
correction, and other areas involved in successfully managing
a CRO will be presented. FDA views and legal obligations of
CROs and sponsors, including generation and review of
study reports submitted in INDs and NDAs, will be detailed.
Emphasis will be given to the overall management of CROs;
how to resolve issues of monitoring, timeline lags, and
effective communication.