Quality Oversight of CROs-Clinical Vendors
Mar 24 2014 9:00AM - Mar 25 2014 5:00PM | DIA
800 Enterprise Rd Ste 200
Horsham, PA 19044
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, and large).
This high-intermediate 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 FDA and EMA communications for vendor oversight and the necessity for “managing the clinical trial for quality”, this course focuses on key quality principles and methods for defining, assessing and overseeing outsourced activities for quality.
Course Level: Intermediate
What You Will Learn
- Historical and regulatory background for the current vendor oversight landscape
- Vendor Life Cycle Management ? Why is this needed? What is the benefit to my organization?
- What are the regulator's saying about vendor oversight?
- The application of Quality Management Systems in vendor oversight
- Vendor Governance Structures: Right-sizing for your organization
- Time for Change? Re-thinking the current paradigm for vendor RFPs – early identification of potential risks
- What are the risks with outsourcing?
- Focus on quality and risk: RFP content and selection methods for early identification of risks with vendors and their capabilities
- The role of the Project-Protocol: Quality Plan for Vendor Oversight
- Vendor Oversight: Roles, Responsibilities, Qualified Staff for Oversight Activities, and Methods
- Vendor Related Study Plans: Vendor Management Plan, Vendor Quality Management Plans, SOPs,Training and Equipping Staff for Vendor Oversight
- Metrics: Overview and 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, sponsors, CROs, ACROs, AROs, NIH, DoD, and VA.
At the conclusion of this activity, participants should be able to:
- Recognize the criticality of an organizational definition for “quality” that drives clinical trial and vendor oversight
- Discuss the principles, tenets and methods for vendor oversight
- Explain methods to manage and monitor the vendor's performance utilizing in-process monitoring assessments and methods, audits and metrics
- Describe vendor governance and management infrastructure for reference and use
Group Discounts Available! Register 3 and Get the 4th FREE!
Hotel & Travel
Training Course Location
800 Enterprise Road, Suite 101
Horsham, PA 19044
Staybridge Suites Philadelphia- Montgomeryville
119 Garden Golf Blvd
North Wales , PA 19454
A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until March 9, 2014 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 $109
Click here for more hotel information
Toll Free 1.888.257.6457
Monday-Friday 8:30AM-8:00PM ET
Agenda Details and Event Logistics
Colleen Buckley, Event Planner
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 (703) 506-3275.
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 1.4 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
|Quality Oversight of CROs-Clinical Vendors
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 activity, sign-in at the DIA registration desk each day, and complete the online credit request process through My Transcript at www.diahome.org . 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 activity.
Please note: If you do not sign-in, you will not receive CE credit as partial credit will not be awarded.
To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE
- Charitable Nonprofit/Academia Member
- Member Government
- Member Standard
- Charitable Nonprofit/Academia Nonmember
- NonMember Government
- NonMember Standard
Printable Registration Form
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.
Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.
Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.
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.
Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.