Clinical Project Management

GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the data obtained. Requirements include but not are limited to, contract research organizations, clinical investagators, manufacturers of drug substance and drug product used in clinical studies and commercialized, packages, labelers and distributors, testing laboratories and warehouses.

In order to ensure compliance by employees and vendors you must have in a robust program for oversight of their activities, and a program for mitigating against risks that may arise related to key vendors. They must also have internal systems to ensure appropriate oversight and management of the program and data. This program will provide considerations for vendors, implementing a robust qualification & selection process, strategies for oversight and management of vendors, and a risk mitigation approach for key vendors. It will also provide considerations for internal oversight programs and tools for various phases of development.

Why You Should Attend:

This program will address the regulatory & legal requirements related to clinical trials and the sponsor responsilbilities for effective management of clinical trials. Learn toidentification & implement systems to effectively select & manage vendors and clinical sites, and monitoring programs.

Areas Covered in the Session :

• Regulatory requirements for clinical trial management
• Legal consideratons
• Elements to consider In setting up and managing clinical trials
• Formats and essential components of SOPs for CTM
• SOP training and implementation
• Systems to assist in CTM
• Vendor selection oversight

Who Should Attend:

• Quality Departments
• Regulatory Departments
• Compliance Departments
• Clincial Supervisors
• Auditors
• Clinical investigators, site management and contracting personnel
• Clinical operations
• Project managers
• Data management
• Medical writers
• Everyone who is required to understand clinical trial management

Course Director: PEGGY J BERRY

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book “Choosing the Right Regulatory Career” (RAPS, MD) and author of the 2011 book “Communication & Negotiation” (RAPS, MD).