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2-day In-person Seminar

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


June 15th & 16th, 2017

Time: 9:00 AM to 6:00 PM

Zurich, Switzerland

Venue: Hilton Zurich Airport


Director : David R. Dills

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

  Price: $1,695.00
(Seminar Fee for One Delegate)

  Register for 5 attendees   Price: $5085.00
      $8,475.00 You Save: $3390.00 (40%)*
Register now and save $200. (Early Bird)
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    • Until May 10, Early Bird Price: $1,695.00 From May 11 to June 13, Regular Price: $1,895.00
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
  • 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 practices
  • A clinical research program must be subject to oversight from an independent Ethics Committee
  • 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 Management
  • Regulatory Affairs Specialist
  • Auditors
  • Compliance Specialist
  • Clinical Affairs
  • Quality Assurance Management
  • Consultants

Day 1 Schedule


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

Exercise and Recap of Day 1


  • Clinical and Data Management Discussions
  • Review of Regulatory Documents

Day 2 Schedule


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
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Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

David R. Dills

Regulatory Affairs & Compliance Consultant,

David R. Dills, Global Regulatory Affairs & Compliance Consultant, has an accomplished record with more than 26 years of experience within regulatory affairs, compliance and quality consultative services for early-stage/established Class I/II/III medical devices, IVDs, and bio/pharmaceutical manufacturers on the global landscape. Previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO, has worked directly with and for manufacturers engaged in compliance remediation activities involving consent decrees, CIA's, FDA warning letters, and customer generated compliance events, provides Strategic GxP Compliance and Regulatory Consulting, handles all aspects of global regulatory submissions and dossiers, including 510(k), PMA, Design Dossiers, Technical Files, CMC, NDA, and IDE submissions, currently serves as a U.S. Agent, works with stakeholders and Center Reviewers regarding submission meetings/negotiations, clinical affairs, and provides regulatory submissions and post-market project leadership/guidance covering different therapeutic and medical specialties based on classification. His background encompasses broad capabilities in regulatory and compliance oversight and governance, including CAPA, Design Controls, Validation, Software Quality with regulatory oversight, FDA Mock Inspections, remediating documentation management systems, Supplier Quality, Adverse Event Reporting, Product Complaints, GxP Training, interpretation and applicability of FDA and international regulations and standards, postmarketing surveillance, ISO 13485 and CE Mark, Medical Device/IVD/Active Implantable Directives. Mr. Dills leads and manages efforts involving multi-country product registrations and licensing in Asia Pacific, EMEA and The Americas from premarketing to postmarketing, and works with the Regulatory Authorities and strives to provide consistent, practical compliance solutions that work with reduction of regulatory compliance risk.

Location: Zurich, Switzerland Hotel: Hilton Zurich Airport   Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

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