Meet our President

Liz Wool
Liz Wool, CCRA. CMT
President & CEO
QD-Quality and Training Solutions, Inc.
Member, Board of Trustees
Association of Clinical Research Professionals (ACRP)

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615.732.6035

Office hours: 8:30 am to 5 pm CST.

MCC Member

classroom diversity

Engagements 2013

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January, 2013
CAPA Fundamentals Workshop, Developing CAPAs in the GCP Environment Conference
ExL Pharma

February, 2013
Audit-Readiness — Evaluating & Taking Steps to Ensure You Are Audit Ready Webinar
Society of Clinical Research Sites

February, 2013
Vendor Quality Oversight Webinar
DIA GCP SIAC

March, 2013
Reality vs. Perception — What a Site Really Needs To Do To Be GCP Compliant Webinar
Society of Clinical Research Sites

March, 2013
Advanced Clinical Vendor Oversight: Vendor Lifecycle Management
DIA Course

April, 2013
Successful Risk-Based Monitoring Implementation: Effective Strategies and Tactics for Your Organization
ACRP Global Conference

April, 2013
Successful Risk-Based Monitoring Implementation: Effective Strategies and Tactics for Your Organization
ACRP Global Conference

June, 2013
FDA Expectations in 2012: Investigator - Site
Health Care Compliance Association Research Conference

June,2013
Quality Oversight of CROs-Clinical Vendors
DIA Annual Meeting Tutorial

August, 2013
Risked Based Site Management Webinar
Society of Clinical Research Sites

December, 2013
Top 3 Audit Findings and Tips and Tools To Prevent Them Webinar
Society of Clinical Research Sites

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Home • Training Solutions • Training Institute of the Pacific • Introduction to Drug Development
Introduction to Drug Development

Mortar & Pestle

This course provides an overview of the development of drugs from discovery to commercialization. The role of the US Food and Drug Administration throughout the drug development lifecycle is discussed in conjunction with their relationship with the sponsor company to bring safe and effective products to market.

 

Faculty:
Liz Wool, RN, BSN, CCRA, CMT
President
Association of Clinical Research Professionals (ACRP)
Northern California Chapter
President and CEO, QD-Quality and Training Solutions, Inc.™

Duration: 8 hours (1 day)

 

Course Objectives

  • Describe the sponsor and FDA responsibilities in drug development.
  • Recognize the activities involved in research and early development.
  • Explain the drug development lifecycle.
  • Describe the phases of clinical development.

 

Course Outline

  • Historical Overview of Drug Development
  • Sponsor Role and Responsibilities
  • FDA Role and Responsibilities
  • Regulations governing Drug Development
  • Drug Development Activities and Timeline
  • Research and Early Development Activities
  • Pre-clinical Evaluation/Testing
  • First in Human Evaluation
  • IND Application/Submission
  • Clinical Development: Phases and Activities
  • NDA Application/Submission
  • Post-Approval Sponsor Responsibilities
  • Wrap-Up

 

Registration

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Random Testimonial

"Liz is an excellent presenter and instructor. This course provided me with additional knowledge and skills to bring to my job."

Quality Oversight 101: Developing a Vendor Quality Management Plan
Sabrina Covic-Savic, The Medicines Company