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Good Clinical Practices (GCP) 2017

Monday, Jun 19, 2017 at 9:00AM - Tuesday, Jun 20, 2017 at 6:00PM


  • Jun 2017

    19 Mon


  • Jun 2017

    20 Tue


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Good Clinical Practices (GCP) 2017

Monday, Jun 19, 2017 at 9:00AM - Tuesday, Jun 20, 2017 at 6:00PM

Hong Kong, CA

No tickets available


"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
  • 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
  • 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
  • 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
  • Good Clinical
    Practice regulations require sponsors of a clinical trial to contain a clearly
    defined protocol that should be rooted in established scientific principles and
  • A clinical
    research program must be subject to oversight from an independent Ethics
  • Good Clinical
    Practice regulations requires the sponsor to obtain informed consent from each
    of the subjects
  • Good Clinical
    Practice regulations requires adherence to set documentation practices
  • There should be
    thorough confidentiality of information relating to the subject
  • The adherence
    to applicable Good Manufacturing Practices (GMP) by the sponsors when it comes
    to the manufacture, storing and handling of investigational products is another
    requirement of Good Clinical Practice regulations
  • The principles
    of Good Clinical Practice regulations require the implementation of systems
    with procedures that bring about complete quality at every stage of the
    clinical trial
  • New Clinical
    Trials Regulation - EU No. 536/2014 (repealing Directive 2001/20/EC)
  • GCP
    Regulations, Guidance and Additional Resources


Who Will Benefit:

This seminar will provide an
overview and in-depth snapshot of GCP regulations with a global overview.
Employees who will benefit include all levels of management and departmental
representatives from key functional areas and those who desire a better
understanding or a "refresh" overview of the GCP process, including

  • Clinical
    Research Associates who want a greater understanding of the medical device
    clinical trial process and their role in it
  • Clinical Project
    Managers who are taking on a wider range of responsibilities and need to gain a
    greater understanding of the regulatory and practical issues involved in
    medical device clinical trials
  • Regulatory
    Affairs Professionals who may be new to the device industry or new to the
    clinical trials process
  • Clinical
    Investigators and Clinical Research Coordinators interested in gaining a
    broader understanding of their role and responsibilities and how these tasks
    relate to the overall research process
  • Regulatory Affairs
  • Regulatory
    Affairs Specialist
  • Auditors
  • Compliance
  • Clinical
  • Quality
    Assurance Management
  • Consultants




Day 1 Schedule


Good Clinical Practices

  • Introductions
    and Background
  • What is GCP?
  • Why should we
  • The Basic
    Principles of FDA and ICH GCP
  • The 13 Basic
    Principles of ICH GCP
  • Key ICH
    Guidelines and FDA Resources
  • Compliance
    Guidance Manuals
  • Impact of ICH
    GCP in the US
  • FDA Acceptance
    of Foreign Studies
  • FDA and
    International Regulations and Guidance Relating to Good Clinical Practice and
    Clinical Trials
  • FDA and
    Institutional Review Board (IRB)/Independent Ethics Committee (IRB/IEC)
  • Responsibility
    of the IRB/IEC
  • Subject
    Informed Consent Forms
  • Informed
    Consent of Trial Subjects
    interactions with Sponsors and Investigators
  • FDA's IRB
  • FDA
    Responsibilities of Sponsors and Investigators
  • Investigator
    Records and Reports and Other Required Documentation for Good Clinical
  • Disqualification
    of a Clinical Investigators
  • ICH Sponsor
  • FDA-Specific
    Sponsor Responsibilities
  • Working with
    Contract Research Organizations (CROs)
  • Trial
  • Data Management
  • Recordkeeping
    and Documentation
  • Compensation to
    Subjects and Investigators and Other Financial Considerations


Exercise and Recap of Day 1


  • Clinical and
    Data Management Discussions
  • Review of
    Regulatory Documents

Day 2 Schedule


Good Clinical Practices

  • Monitor
  • Complying with
    the Protocol, Amendments, SOP and Guidance
  • Fraud and
  • Safety &
    Adverse Event Reporting
  • Clinical Trial
    Protocol and Amendments
  • Investigator
    Brochure Requirements
  • Essential
  • Tips for
    Regulatory Inspections - Common Findings
  • Bioresearch
    Monitoring Program (BIMO)
  • BIMO inspection
    metrics (clinical investigators, IRBs, sponsors, etc.)
  • Reporting
    Complaints Related to FDA-Regulated Clinical Trials
  • GCP Inspections
  • Additional FDA
    Guidelines and Resources


Exercise and Recap of Day 2


  • Clinical and
    Data Management Discussions
  • Review of
    Regulatory Documents




  • Recap of topics
    and key discussion points and take away message
  • FAQs and latest



David R. Dills

Global Regulatory Affairs &
Compliance Consultant 

David R. Dills, Global Regulatory
Affairs & Compliance Consultant currently provides regulatory affairs and
compliance consultative services for early-stage and established Class I/II/III
device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on
the global landscape, and has an accomplished record with more than 27 years of
experience in the areas of Regulatory Affairs, Compliance and Quality Systems.
He has been previously employed, with increasing responsibilities by device
manufacturers and consultancies, including a globally recognized CRO and has
worked directly with manufacturers engaged in compliance remediation activities
involving consent decrees, CIA's, warning letters, and customer generated
compliance events, conducts QS, regulatory, compliance assessments/audits and FDA
Mock Inspections for State of Readiness. He has been directly involved with
constructing, reviewing, and remediating regulatory submissions, U.S. Agent for
OUS companies, works closely with the key stakeholders and Agency/Center
Reviewers regarding submission meetings and negotiations; clinical affairs/CTM
and provides regulatory submissions and post-market project leadership and
guidance covering multiple therapeutic and medical specialties based on
classification. He has a strong background in the interpretation and
applicability of FDA and international regulations, leads activities for the
registration and approval process and working with the Agencies in Asia
Pacific, EMEA and The Americas, including FDA, European Medicines Agency-EMA,
MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management
on regulatory strategies and plans supporting a company's commercialization
strategy. He directs and leads efforts for PM support involving all phases of
the premarketing to postmarketing; establishes Medical Device Single Audit
(MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance
strategies; lead efforts regarding AE/Incident Reporting, all aspects of
Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation
systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File,
Design Dossier and CER consultation; and facilitates multi-country product
registrations and licensing. He recommends action to senior leadership to
ensure effective resolution for manufacturers to achieve sustainable and proven
compliant systems. Background encompasses broad capabilities in quality
systems; documentation development and remediation; regulatory oversight and
governance; design controls; CAPA investigations; GxP training; software
embedded medical devices/all aspects of SW/SDLC and process validation with
compliance oversight; supplier management; and demonstrates credible experience
to optimize business performance through proactive strategies to mitigate
compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the
Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation
Technology (IVT), publisher of the Journal of GXP
Compliance and Journal of Validation Technology
 and on the Readers' Board for Medical Device & Diagnostic Industry and Medical
Product Manufacturing News
was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's
Who of Professionals. Mr. Dills has authored and published validation,
regulatory and compliance-related articles, commentaries and technical guides,
and is an accomplished global industry presenter. Mr. Dills' academic degrees
include Environmental Science and Biology. He is a former Chair and Co- Chair
of ASQ's Section 1506 and affiliated with the Biomedical Division, RAPS,
AdvaMed, PDA, ISPE, and other industry working groups.


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



18 Salisbury Road, Kowloon, Hong Kong



Register now and save $200. (Early

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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Phone: 1-800-447-9407

Fax: 302-288-6884




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