Take advantage of our $1675.00 price by registering early!
* After Friday, July 27, 2018, costs are $1875.00.
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.
- 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
- Study Coordinators
- Site Manager
- Project Managers
- General Managers
- Project and Department Leads
- Clinical Research Associates
- Regulatory Managers
- Clinical Trial Assistants
The course will be led by one of the following
Christison, B.S., C.C.R.A.
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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
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
- Team review of guidance documents and
presentations of practical elements and applications
- GCP advanced case studies
- Risk identification and proactive
- RCA and CAPA practical applications
- Group development of best practices
for audits and inspections
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
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.
this course at your company! For more information, contact Naila Ganatra at +1