ICH GCP E6 R2 Meeting CRO-Vendor Oversight Requirements

ICH GCP E6 R2 Meeting CRO-Vendor Oversight Requirements

An Interactive Workshop Presented by CenterWatch and Wool Consulting Group

MARCH
27

March 27-28, 2019
Marriott Raleigh Crabtree Valley • Raleigh, NC

What CRO and vendor activities require oversight?

How can you avoid the common pitfalls of effective implementation of CMO-vendor oversight?

How are your fellow CROs handling these and other issues?

Join them and nationally recognized expert Liz Wool, CCRA, CID, CMT for face-to-face discussions on how to handle ICH GCP E6 R2 compliant CRO-vendor oversight.

Liz will provide methods and solutions for effective implementation of the ICH GCP E6 R2 rules. Over the course of the two-day hands-on workshop she’ll:

  • Explain the regulatory authority perspective for CRO and vendors in relation to ICH GCP E6 R2 requirements
  • Identify the CRO-vendors requiring oversight
  • Determine the CRO-vendor practices for oversight of their sub-contractors to meet the requirements and your organization’s expectations
  • Examine effective and compliant CRO-vendor oversight methods
  • Assess CRO-vendor governance-leading practices to implement at your organization
  • Formulate a CRO-vendor oversight plan template for your organization that can be used by multiple departments
  • Examine the common pitfalls to effective implementation and leading practices to mitigate the risks of these pitfalls from occurring in your organization
  • Describe regulatory authority inspection findings regarding CRO-vendor oversight

View the agenda.

Through presentations, discussion, class activities and handouts you’ll learn how to implement ICH GCP E6 R2 requirements in your organization. Join us for two days of networking and face-to-face interaction with a nationally recognized CRO-vendor expert.

Course Binder Materials

  • Presentation slides and workshop handouts
  • Copies of applicable FDA regulations
  • Copies of applicable FDA guidance documents
  • Relevant international guidance documents

Who Will Benefit?

  • CRO Professionals
  • Clinical Research Managers/Associates
  • Regulatory Affairs Managers/Associates
  • Pharmacovigilance Managers/Associates
  • Clinical Operations Managers/Associates
  • QA Managers/Associates
  • QC team members
  • Quality Unit Managers And Leaders
  • Quality Auditors
  • Procurement Specialists
  • Business Development Personnel
  • Technical Services

 

Meet Your Presenter:

Tiffany GuckinLiz Wool, CCRA, CID, CMT has 29 years clinical research experience in clinical operations, compliance, CRO-vendor oversight and training, She is a certified CRA (ACRP), instructional designer and master trainer and a member of the National Speakers Association. She is a recognized industry expert on CRO-vendor oversight/management who has presented on this topic in both the United States and the European Union since 2010 for both nonprofit professional associations (DIA) and industry conferences.

REGISTER NOW
Tuition
Regular Price: $1,797.00
Early Bird Price: $1,597.00

 

Early Bird Savings: Register by March 1 and Save $200

Team Discounts: Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount. Call +1 (703) 538-7600 for details.

Hotel Reservations: To reserve your room, call the hotel at (919) 781-7000. Be sure to tell the hotel you’re with the CenterWatch Workshop to qualify for the reduced rate. Only reservations made by the reservation cutoff date are offered the special rates, and space is limited. Hotels may run out of discounted rates before the reservation cutoff date. The discounted rate is also available two nights before and after the event based on availability. Hotel may require first night’s room deposit with tax. Room cancellations within 72 hours of the date of arrival or “no-shows” will be charged for the first night’s room with tax.

Cancellations/Substitutions: Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future CenterWatch event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that CenterWatch cancels the event, CenterWatch is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Briefing: Tuition includes all workshop sessions, workshop written materials, luncheon and refreshments each day.

Workshop Details:
March 27-28, 2019
Marriott Raleigh Crabtree Valley
4500 Marriott Dr.
Raleigh, NC 27612
Phone: (919) 781-7000
Group rate: $179.00 + 13.25% tax
Reservation Cut-off: March 4, 2019
Complimentary self-parking
Complimentary airport shuttle 7am-9pm (Call hotel for details)
www.RaleighMarriottCrabtreeValley.com