Advanced Clinical Vendor Oversight: Vendor Life Cycle Management
Mar 26 2013 8:30AM - Mar 27 2013 5:00PM | DIA
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509
In today's complex clinical research environment with global trials, various financial models and reduced resources to execute clinical trials, sponsors hire various vendors/suppliers to meet the needs of the clinical trial/clinical program. Whether the selection of vendors is in a 'preferred provider' model or not, companies find themselves with the need to select and manage vendors in a highly scrutinized regulatory landscape for vendor oversight. As regulators state, sponsors may transfer their obligations to a vendor for specific activities related to a clinical trial, but it is the sponsor who is ultimately held accountable for the work performed on their behalf. This is a requirement for 'any size' of an organization (virtual, small, medium, large).
This course addresses vendor management utilizing a quality management life cycle approach that supports systematic, quality-driven oversight, such as: selection of vendors, identification of risks with a vendor 'upstream' in the process of vendor management (vs. downstream - when the trial is conducted), as well as vendor oversight and management. Referencing the FDA, FDA-CTTI and EMA initiatives influencing industry to 'build quality into the clinical trial', this course focuses on key quality principles and methods for defining, assessing and overseeing outsourced activities for quality.
Vendor Life Cycle Management, which is well-known and utilized in other industries, will be discussed in the class for benchmarking purposes.
What You Will Learn
- Historical and regulatory background for the current vendor management landscape
- What is vendor life cycle management? Why is this needed? What is the benefit to my organization?
- What are the regulator's saying about vendor management
- The application of quality management systems in vendor management
- Vendor governance structures
- Vendor selection: criteria, scoring tools, identification of risks
- Vendor qualification assessment/visits - partnership : QA and functional departments
- Vendor risk management plan
- Vendor management methods
- Vendor related study plans: vendor management plan, vendor quality management plans, SOPs, sponsor training plan, etc.
- Metrics utilization
Who Should Attend
This course is designed for professionals involved in clinical research, clinical operations, outsourcing, regulatory affairs, quality-compliance, and commercial-medical affairs. This course will also benefit project managers and sponsors, and representatives from CROs, ACRO, academic research organizations, NIH, the Department of Defense (DoD), and the VA.
At the conclusion of this activity, participants should be able to:
- Discuss the principles, tenets and methods for Vendor Life Cycle Management.
- Identify the risks of utilizing an outsourcing model
- Describe appropriate methods to assess, identify, manage and monitor the risks
- Explain methods to manage and monitor the vendor's performance utilizing in-process monitoring assessments and methods, audits and metrics.
- Identify gaps with current vendor governance and management infrastructure and the requisite solutions that address the gaps.
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Training Course Location
DIA Worldwide Headquarters
800 Enterprise Road, Suite 101
Horsham, PA 19044Hotel Information
2650 Kelly Road
Warrington, PA 18976
A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until March 11, 2013, or until room block is filled). Attendees should make airline and room reservations as soon as possible.
When making reservations, mention the DIA training course.Standard Room Rate
$119Click here for more hotel information
Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road; Suite 500, McLean, VA 22102.
As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.3 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 8 Elective Units
• Project Management Certificate Program: 8 Elective Units
For more information go to www.diahome.org/certificateprograms
|Adv.Clinical Vendor Oversight: Vendor Life Cycle M
It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.
Statement of Credit:
If you would like to receive a statement of credit, you must attend the program, sign-in at the DIA registration desk each day of the program, and complete the on-line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the course.
To view DIA’s grievance policy, please visit the CE page on DIA’s website at www.diahome.org
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.
To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.