PHILADELPHIA, Pa., Oct 31 , 2013 – Compliance Implementation Services (CIS), a leading life sciences consulting firm, today announced that it will address the importance of vendor oversight by examining the CIS model for implementing a Vendor Oversight Capability in the complimentary web inar “ Vendor Oversight - The Path Forward . ”
According to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 : Good Clinical Practice , pharmaceutical s ponsor s of clinical trial s may transfer any or all trial - related duties to a contract research organization (CRO) (s); however, the s ponsor still retains ultimate responsibility for the trial and thus must provide oversight of the work completed by the CRO(s). To ensure CRO compliance with regulations and contractual obligations, now is the time to identify any gaps in your current oversight capability, make certain roles and responsibilities are clearly defined, and assess all processes, tools and training programs that may impact oversight responsibilities .
CIS will discuss the importance of vendor oversight given current industry trends and increased regulatory focus on this topic. Attendees should walk away with an understanding of what a Vendor Oversight Capability is along with suggestions for how they can implement a Vendor Oversight C apability within their own organization.
Key takeaways from this webinar include:
? FDA's recommendations with regards to Vendor Oversight
? An understanding of a Vendor Oversight Capability
? The important elements that make up a Vendor Oversight Capability
? T he steps for determining what it takes to institute and sustain an effective Vendor Oversight Capability within your organization
CIS’ Kirsten Morasco and guest speaker Holly DeIaco - Smith will host the complimentary webinar on Tue sday, November 5 th 1:00 pm EST. To register and submit questions in advance, visit http://cis - partners.com/category/insight/webinars - insight/#vendor - oversight - the - path - forward .
About Compliance Implementation Services (CIS)
Compliance Implementation Services (CIS) is a consulting firm focused on helping life sciences clients proactivel y manage complex compliance requirements. We offer a broad portfolio of services and solutions that expand deep into the clinical, manufacturing and commercial disciplines and that align with our clients’ strategic priorities and business operations. CIS c ontinually provides leadership, global regulatory knowledge, industry experience and a problem - solving culture that responds to today’s compliance and commercial challenges. For more information, visit www.cis - part ners.com
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