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Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2)

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
393

Room Number:
16B

Level:
Intermediate

Type:
Workshop

Title:
Clinical Study Risk Management: What Does It Really Mean and How Do You Do It? (Part 2 of 2)

Chair(s):
Liz Wool, BSN, RN
President and Chief Executive Officer; Past-Member, Board of Trustees, ACRP
QD-Quality and Training Solutions Inc., United States

Description:
The lessons learned from Part 1 of this two-part workshop will provide the foundation for participants to apply the learned principles. Participants will have the opportunity to develop a study risk plan, identify and prioritize the risks, and determine a control plan (including tolerance levels). Participants will analyze factors critical to quality and successful study execution for the development of a risk management plan.

This workshop has been developed by the DIA Data Management, Good Clinical Practice/Quality Assurance, Quality Risk Management, and Statistics Communities.

Preregistration is strongly recommended, and attendees are expected to attend both Part 1 and Part 2.

Part 1 will take place on Wednesday at 1:30 pm (Session #367).

To secure a seat for this specific workshop, please email annualmeetingprogram@diahome.org, Subject line: Clinical Study Risk Management Workshop.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.

Learning Objective(s):
Identify the foundational principles discussed in the Part 1 workshop to develop a study risk plan; Perform critical analysis of study risk plan.

Presentation(s) & Speaker(s):
Facilitator
Johann Proeve, PhD
Vice President, Global Strategy and Development Advisor
Bayer HealthCare, Germany

Facilitator
Kristin M. Neff, MS
Vice President
InVivo Therapeutics, United States

Facilitator
Dale W. Usner, PhD
Vice President, Biostatistics & Data Management
SDC, United States