Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Efficient and effective management of clinical trials can significantly impact the time, scope and budget for the development of a drug. Project managers must understand the development process and the key aspects of all phases of Clinical Development in order to act, react and adapt to change when the program moves forward and new data is acquired. Successful completion of Phase 1 and Phase 2 clinical trials are key project milestones to achieving proof of concept for any new drug. Phase 3 clinical trials are critical to gain regulatory approval for the market and Phase 4 allows expansion and extension of the indication for a drug. This course focuses on the best practices for developing and managing these trials within GCP guidelines and FDA regulations.

The course will discuss the challenges associated with clinical trials run outside the United States and identify key differences, common pitfalls, and cultural differences. Guidance for the how-to as well as problem-solving for specific situations such as slow enrollment, high screen failures, or issues with data quality will be provided. The course is interactive and designed to allow for the exchange of ideas between peers in addition to learning from the instructor.

Who Should Attend

This course is an overview designed for those in the Pharmaceutical and Biotech industries who will manage or direct projects within their functional area related to Clinical Trials. It will also benefit those who need an understanding of industry specific and project management best practices that should apply to their project. This course also applies for current project managers and others who may have cross-functional project management responsibilities.

Typical Attendees include:

• Project Managers, Directors and Leaders
• Clinical Investigators and Study Coordinators
• Clinical Operations Directors and Senior CRA's
• Clinical Trial Managers, Monitors and Associates
• Medical Affairs and Clinical Operations Professionals
• Pharmacovigilance and Labeling Professionals
• Physicians and Medical Liaisons
• Regulatory Affairs Professionals
• Preclinical Development Professionals
• Research and Development Scientists

Kay Monroe

Specialties: Quality, Management

Kay Monroe is Acting Executive Director of Zagaya. This non-profit – specializing in Malaria – works to bring innovative technologies to the problems of global health in the developing world.

Ms. Monroe has spent over 25 years with biotechnology and pharmaceutical companies around the world; working on global project teams from Research through Phase IV and introducing Project Management Offices into several companies. She has extensive experience in product lifecycles and the creation of submission documents. In addition, she has sourced both items and processes for pharmaceuticals, biologics and devices.

Ms. Monroe has held positions as Vice President of Operations, Project Management and Quality Assurance in companies such as Lundbeck, Synarc and Genentech. She has extensive experience in the start-up environment with such companies as Cerus, Dynavax and Amyris.

Ms. Monroe received her Bachelors of Science in Animal Science from UC Davis and her MBA from Golden Gate University.

Courses:

• Clinical Document Management - A Trial-by-Trial Approach to Compliance
• Effective Document Management for the Pharmaceutical, Biotech & Medical Device Industries
• Selecting and Managing CRO's
• Writing Effective Standard Operating Procedures and Other Process Documents
• Writing in the Regulated Environment When English Is Your Second Language