Good Clinical Practice Regulatory Changes, Trends, and Best Practices Implementation

Course Description

This course will review recent FDA guidance documents and general regulatory trends, including revisions to ICH GCP E6 R2 and the repeal of the EU Clinical Trial Directive with replacement with the EU Clinical Trial Regulation 536/2014. With a number of new FDA guidances released over the past several years related to investigator oversight, risk-based monitoring, electronic medical records, and electronic informed consent, the industry must consider the trends and what the regulatory agencies are focusing on. We are seeing revisions in the U.S. and EU related to risk management and oversight that sponsors and sites should be prepared to implement with best practices. With the availability of multiple electronic resources there is an expectation to review information in real time; however, we still need to consider resources, confidentiality, and applications in a global research environment. In this session, we will discuss recent trends, upcoming changes and how to design best practices in an evolving clinical research world.

Learning Objectives

• Review recent FDA guidance documents
• Discuss changes to ICH GCP E6 R2 and the impact on the industry
• Evaluate regulatory trends and applications to best practices
• Review systems and techniques for quality control and proactive risk management
• Apply root cause analysis (RCA) and corrective and preventive actions (CAPA) to issue management
• Apply techniques and tools to manage performance issues and non-compliance

Who Should Attend

• Investigators
• Study Coordinators
• Site Manager
• Project Managers
• General Managers
• Project and Department Leads
• Clinical Research Associates
• Regulatory Managers
• Clinical Trial Assistants     

Instructor

The course will be led by one of the following instructors:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM., P.M.P.

Lily Romero, P.A., C.C.R.C.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

• New Developments and Emerging Trends in GCP: FDA Guidance Documents
• ICH GCP E6: Updates with R2 and Rationale  
• Following the Trend and Applying Proactive Risk Management  
• Quality Systems: The Roadmap to GCP  

Day Two: 8:30 a.m. – 5:00 p.m.

• The Role of Standard Operating Procedures in GCP
• Advanced Cases in GCP: Application of GCP, RCA and CAPA
• Recent Non-compliance Issues and Trends  

Interactive Activities

• Team review of guidance documents and presentations of practical elements and applications
• GCP advanced case studies
• Risk identification and proactive management
• RCA and CAPA practical applications
• Group development of best practices for audits and inspections

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

Click here for our seminar cancellation policy

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-17-059-L01-P. Released: 2/17.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.