Past Event

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

19–20 June 2017
Singapore, 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.

Overview:

  • 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

 

Agenda:

 

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

 

Speaker


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 and 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

 

Venue:  Mandarin Orchard Singapore

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

 Price:

 

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

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