David R. Dills is a global regulatory affairs and compliance consultant with over 27 years of experience. He provides consultative services to medical device, biopharmaceutical, and other manufacturers. The document announces a two-day in-person seminar in Hong Kong on Good Clinical Practices (GCP) that Dills will conduct. The seminar will cover topics such as GCP principles and guidelines, clinical trial protocols, ethics requirements, and regulatory documentation and inspections. Attendees will include regulatory affairs specialists and auditors working in clinical research.

1. 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.
David R. Dills
Global Regulatory Affairs & Compliance Consultant
2-day In-person Seminar:
Knowledge, a Way Forward…
Good Clinical Practices (GCP) -
Understanding and Implementing the Current Global Requirements
Hong Kong
June 19th & 20th, 2017
9:00 AM to 6:00 PM
Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
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
$8,475.00
Price: $5,085.00 You Save: $3,390.0 (40%)*
Register for 5 attendees

2. 2-day In-person Seminar:
Good Clinical Practices (GCP) -
Understanding and Implementing the Current Global Requirements
Global
CompliancePanel
Agenda:
Day One Day Two
Good Clinical Practices
Introductions and Background
What is GCP?
Why should we have GCP? (ICH GCP/FDA CFR GCP)
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 GCP Regulation
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
IRB/IEC interactions with Sponsors and Investigators
FDA's IRB requirements
FDA Responsibilities of Sponsors and Investigators
Investigator Records and Reports and Other Required
Documentation for Good Clinical Practices
Disqualification of a Clinical Investigators
ICH Sponsor Responsibilities
FDA-Specific Sponsor Responsibilities
Working with Contract Research Organizations (CROs)
Trial Management
Data Management
Recordkeeping and Documentation
Compensation to Subjects and Investigators and Other
Financial Considerations
Who will benefit:
Regulatory Affairs Management
Regulatory Affairs Specialist
Auditors
Compliance Specialist
Exercise and Recap of Day 1
Clinical and Data Management Discussions
Review of Regulatory Documents
Good Clinical Practices
Monitor Responsibilities
Complying with the Protocol, Amendments, SOP and
Guidance
Fraud and Misconduct
Safety & Adverse Event Reporting
Clinical Trial Protocol and Amendments
Investigator Brochure Requirements
Essential Documents
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
Debrief/Adjourn
Recap of topics and key discussion points and take
away message
FAQs and latest trends

3. www.globalcompliancepanel.com
Kindly get in touch with us for any help or
information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Contact Information: Event Coordinator
NetZealous LLC, DBA GlobalCompliancePanel
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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Group Participation
Payment Option
1 Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
2 Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA
PO: Please drop an email to
support@globalcompliancepanel.com or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884
Wire Transfer: Please drop an email to
support@globalcompliancepanel.com or call our
toll free +1-800-447-9407 for the wire transfer
information
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Global
CompliancePanel
2-day In-person Seminar:
Good Clinical Practices (GCP) -
Understanding and Implementing the Current Global Requirements