The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Apr. 30 & May 1, 2007
Who Should Attend:
This workshop will be of great value to those in the Pharmaceutical, Biotech and Medical Devices industries. It is designed for those who are or will be directing/managing projects within their area of expertise and who need to get a clear understanding of the industry specific best practices as well as the project management best practices that apply to their projects. It is intended also for current project managers and others with cross-functional project management responsibilities in the Pharmaceutical and Biotechnology industries.
Typical Attendees include:
• Project Managers, Directors and Leaders
• Clinical Investigators and Study Coordinators
• Clinical Affairs Directors and Senior CRA’s
• Research and Development Scientists
• All Medical Affairs and Clinical Operations Professionals
• Regulatory Affairs Personnel
• Preclinical Development Director/Associate/Scientist
• Toxicologist/Director of Toxicology
• Pharmacovigilance & Labeling Professionals
• Pharmacologist/Director of Pharmacology
• Clinical Trial Managers, Monitors and Associates
• Physicians and Medical Liaisons
This course will provide a thorough understanding of the activities involved during the Phase 1 and 2 stages of Drug Development. The intent of the course is to provide detailed knowledge of the project management practices that will make the difference between a successful clinical trials and a trial that does not meet its goals.
By the end of this workshop, participants will be able to:
• Understand the overall Drug Development process and the unique aspects of Phase 1 & 2
• Apply Best Practices in Project Management to Clinical Trials
• Manage a development project team and recognize the specific needs and leadership skills required for this stage of the drug development process
• Refine the Target Product Profile and position the product for future launch
• Understand GCP Guidelines, FDA Regulations and ICH Guidelines
• Manage the challenges associated with implementing clinical trials outside of the USA
• Select between the main two European routes of submission
• Define accurate clinical trials timelines and budgets
• Achieve high quality clinical data and Optimize Study Logistics
• Define and manage enrollment toward success
• Successfully manage clinical supplies in your project plan
• Manage Adverse Events Reporting and Protocol Deviations
• Prevent and manage fraud and misconduct
Efficient management of early phase clinical trials can significantly impact the viability of a drug or device. In such an environment, project managers must be nimble and adept at change. Clinical Trials for Phase 1 and phase 2 are significant milestones toward success. This course focuses specifically on the best practices for developing and managing these trials. It combines best practices in product development and clinical trials with GCP guidelines and FDA regulations. It will provide each participant with a list of practices to follow and a list of pitfalls to avoid. This is based on several hundreds of clinical trials conducted by small and large biotech companies as well as pharmaceutical companies.
This training will explore the challenges encountered when conducting trials outside of the United States and discuss language, cultural differences, medical practices and much more. We will also discuss how to respond to specific situations such as an enrollment not meeting expectations or the quality of the trial data being “too perfect”. The course is presented in a dynamic, interactive manner to facilitate learning and retention.
Drug Development Process and Project Teams
• Outline the drug development process
• How does Project Management fit?
• Best Practices in Project Management applied to the Drug Development Process and Current Trends
• Project Core Teams, Project Managers and Leaders
• Leadership Skills
Target Product Profiles and the Clinical Trial Process
• Review the Target Product Profile
• The Clinical Trial Process
GCP Guidelines and FDA Regulations
• The Regulations
• Who is responsible? Sponsor, Monitor, Investigator
• How can Project Management roles help clarify responsibilities?
The Project Operating Guideline
• A key document to manage expectations
• How does the POG differ from a contract or a project plan?
• Best Practices
• Measuring Performance of the POG and related SOPs
Clinical Trials Timelines and Budgets
• Generally accepted metrics
• Developing an accurate timeline – key to success
• Budgets, Grants, Contracts (selecting the best option)
Additional Challenges with Global Trials
• European Submission Procedures and its impact on timelines
• What about culture, language and medical practice?
• Logistics issues (import/export documentation; manufacturing issues; Qualified Person…)
• How to take advantage of each country requirements to become more efficient?
Project Monitoring and Control
• Establishing a reliable baseline
• Selecting the right level of monitoring
• Ensuring High Quality Data
• Reporting Requirements
Subject Enrollment Strategy
• Target, Timelines and Investigators Selection
• Best Practices
• How to enhance Patient Recruitment
• Manufacturing Authorization
• Ordering and Labeling Lessons Learned
Global Deliverables and Managing Adverse Events
• Who needs to know what?
• Study Completion Best Practices
• Adverse Event Reporting (Requirements and Management Considerations)
• Drugs versus Medical Devices
• AEs versus Serious Adverse Events (SAEs)
• Fraud and Misconduct
Summing it all up