Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements 2017

  • 1695.00 Dollar US$
  • Published date: April 24, 2017
    • INTERCONTINENTAL HONG KONG, Hong Kong, Singapore

Course "Good Clinical Practices (GCP) - Understanding and Implementing the Current Global Requirements" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
• Defining the basic requirements of Good Clinical Practices
• Clinical Study Protocol Elements and Device Accountability
• Role of Institutional Review Board (IRB) and Informed Consent
• Principles of Ethics and Quality Control
• Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
• Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
• Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
• Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials
• And Much More...

Why should you attend:
• What is GCP and why is it needed?
• History and development of GCP in EU and US and where are we now?
• Managing problem areas of working with GCP regulations and guidelines
• Impact of GCP globally and key FDA differences
• Recognize the regulatory pathways in the U.S
• Explore practical aspects of investigator and monitor selection
• Discuss how to comply with the fundamentals of Good Clinical Practice (GCP)
• Examine practical aspects of conducting international clinical trials
• Understand the significance of Ethics and Human Subject Protection
• Understand how to prepare for audit and inspection of clinical trials
• Recognize what prompts an FDA audit
• Learn how to plan for an audit or inspection, including using appropriate checklists
• Appreciate how to prepare for audit/inspection Interviews
• Consider how to respond to the audit/inspection findings
• How to monitor clinical trials effectively and efficiently
• Comprehensive overview of the applicable regulations on good clinical practice and clinical trials
• Attendees are encouraged to discuss GCP work related activities associated with their functional area on the various topics as applicable for interactive group discussion
• Review and discuss pain points, challenges and solutions

Areas Covered in the Session:
• Adherence to ethical principles as laid out by the Helsinki Declaration
• Good Clinical Practice regulations require that clinical trials be consistent with regulatory requirements
• Good Clinical Practice regulations require the sponsor to make available clinical and nonclinical data from the study to support further related research
• Trials should thoroughly assess the risks and benefits inherent in a clinical research
• The clinical research should ensure the wellbeing of its subjects

Location: Singapore Date: June 19th & 20th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: Mandarin Orchard Singapore
Address: Mandarin Orchard Singapore 333 Orchard Road, Singapore 238867
Tel: (65) 6235 7788

Register now and save $200. (Early Bird)
Price: $1,695.00 (Seminar Fee for One Delegate)
Until May 10, Early Bird Price: $1,695.00 From May 11 to June 17, Regular Price: $1,895.00
Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*

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NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884

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