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

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),

Over View:

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

2-day In-person Seminar:

Good Clinical Practices (GCP) - Understanding and Implementing the

Current Global Requirements

Areas Covered in this 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

Agenda:

  Day One - 

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 -

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