Industries: Pharma / BiotechMedical Device

Good Clinical Practices (GCP) & Risk Based Monitoring - Understanding and Implementing Current Global Requirements

Course Director: Michael A. Pierro

 

Course Fee: $2650.00 Regular Registration / $2450.00 Early Bird (30 Days in Advance)

  Accreditation: ***RAPS Approved Course***

Certification Tracks

This Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors. 

Course Description -

This GCP training course is designed to provide individuals with an in-depth understanding of the clinical research process, the roles and responsibilities of key players, as well as the current regulatory requirements (US & EU).  The course consists of lecture, exercises and simulations designed to emphasize hands on practical implementation of the GCP requirements.  This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. This will include practical knowledge on how to implement a risk-based monitoring approach to promote quality in your clinical trials.  Attendees will also conduct a virtual study site visit to determine regulatory and protocol compliance and develop a CAPA. They will experience real life situations such as reviewing case report forms for accuracy and adherence to protocol, performing source document verification and developing a plan to bring the site into compliance.

Attendees will gain experience in proven techniques for detecting, correcting, and preventing clinical study deficiencies at domestic and international clinical sites by maximizing risk-based considerations. Included in the course work are practical examples of documents such as Form FDA 1572, Informed Consent, EU CTA, Investigator brochures, protocol TMF and source documents through presentation and case studies.  The GCP training course will also provide the attendee with thorough knowledge of the following topics:

  • The different phases of clinical research

  • What constitutes Good Clinical Practices (GCP)

  • The principles of ICH GCP

  • The IRB/IEC’s composition and role/responsibilities

  • The IRB study review & approval process 

  • The role and responsibilities of the investigator & study site staff

  • The role and responsibility of the sponsor

  • Key requirements for GCP as defined by ICH and ISO Guidelines

  • Which sections of 21 CFR, EU Regulation and ICH Guidelines govern conduct of clinical studies

  • The purpose for an IND / CTA and its composition

  • The IND/CTA submission & review process

  • The IND/CTA reporting requirements 

  • The requirements for Informed Consent

  • The process for Informed Consent review & approval 

  • Risk based monitoring principles and goals

  • Designing and implementing a monitoring plan

  • The different types of study Monitoring visits & tasks

  • Adverse Events - the types and reporting requirements

  • Differences between the FDA and EU Regulations

Who Should Attend

The Regulations governing drug development and ICH Guidelines require that everyone involved in the oversite, conduct, evaluation, and audit of clinical studies be up to date in their GCP training.  You are also required to be re-trained periodically (every 2-3 years). This training program will fulfill your regulatory requirements for initial and periodic/updated GCP training.

This three-day newly revised Good Clinical Practices (GCP) course is specifically designed for Clinical Operations Staff (Study Managers, Medical and Study Monitors) as well as GCP Auditors and others involved in managing, conducting and monitoring or QA of clinical studies of new medications who require a working knowledge of the current regulatory requirements (US and EU) and ICH Good Clinical Practices (GCP) Guidelines.  This learning experience will provide attendees with the skills required to improve clinical trials and ensure compliance with Good Clinical Practice. Practical application of the FDA 21CFR, new EU Regulation and current ICH Guidelines will be stressed.  

Clinical Operations and Audit staff who work for Pharmaceutical or Biological firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the conduct, oversight or audit of clinical trial practices and policies will find this course of interest.  Other research professionals, (i.e., clinical investigators, research coordinators, regulatory and medical communications personnel) will also benefit from this interactive GCP training program.

 

Course Agenda

Day One

Welcome & Agenda Review

Lesson 1: Introduction to Good Clinical Practices

  • GXP: the regulations governing drug development
  • Components of GCP
  • Global Principals of GCP
  • ICH
    • Gal, Significance, Impact
       

Lesson 2: History of the Regulations – US & EU

  • History of Regulations in the US
    • Cmparison of US Regulations & ICH Guidelines
  • History of Regulations in the EU
  • The differences between the US & EU Regulations governing drug development

Lesson 3: Drug Development Process

  • Global Drug Development process flow
  • Pre-clinical Testing
    • Objectives & tols
    • Utilizatin of data
  • Steps in Clinical Development
    • Phases 1 – 4
      • Objectives, characteristics & study designs
      • Adaptive Clinical Trials

Lesson 4: Key Definitions

Lesson 5: GCP Documentation

  • Regulatory Documents
    • Regulatins & Guidelines
    • ICH GCP guidelines
      • Roles & Responsibilities
        • Sponsor
        • Investigator
        • IRB/EC
  • Protocol
    • Objectives, Purpse Content Requirements & Recommended Template
  • Investigator Brochure
    • Objectives, Purpse, Content Requirements
  • Essential Document Retention
    • ISO standards vs FDA vs EU regulatins
  • Trial Master File
    • Requirements, Cntent, Recommended Template, Maintenance & Archiving
  • ICH E6 (R2) New/current Requirements
  • ISO 14155 – 2021 Requirements
  • ISO vs ICH Documents

Day Two

Lesson 6: Key Players in Clinical Trials

  • Sponsor & Study Site Team
    • Role & Responsibilities
  • IRB/EC
    • Role, Responsibilities & Composition
    • Differences between US IRB and EU EC submission & approval process
  • Study Subject
    • Role
    • Confidentiality: US HIPAA vs EU GDPR

Lesson 7: Traditional Monitoring and Risk Based Monitoring

  • Site Selection
    • Objectives, Tasks Site Assessment, Required Documents & Documentation 
    • Traditional/Routine Monitoring
    • Objectives, Tasks & Documentation
  • Study Close-out
    • Objectives, Tasks & Documentation
  • Traditional Routine Monitoring vs Risk Based Monitoring (RBM)
    • FDA 2019 & EU ICH E6(R2) Guidance Documents
    • RBM rational, advantages, focus & implementation
    • RBM Monitoring Plan

Lesson 8: Documentation Required for Study Initiation

  • Required documentation US vs EU
  • Informed Consent Form, content & process for administration & documentation
    • ICF Guidelines & Template

Lesson 9: The IND / CTA

  • Types & Contents
  • Format
  • Clinical Trial Registration: US vs EU

Day Three

Lesson 10: GCP Adverse Event Reporting Requirements

  • Sources of AEs
  • Pre and Post-marketing reporting requirements
  • SUSAR: definition, documentation & reporting (US vs EU)
  • SUSAR Report Form & reporting differences (US & EU)


GCP Workshop

            Participants working in teams perform a virtual study site visit to:

  • Determine compliance to the regulatory requirements
  • Prepare a CAPA(s) to become & remail compliant

Final Q & A

Learning Objectives

Upon completion of this course, each participant will have a thorough understanding of the latest GCP requirements for monitoring, auditing, and providing oversight of clinical trials as described by FDA, EMA regulations, ICH and ISO Requirements for Sponsors, Monitors, Auditors and Investigators. In addition, the significance of these regulations will be correlated to regulatory document development, submission and archiving for all phases of clinical research. Information regarding in field and in-house auditing (i.e., Quality Assurance (QA) procedures compared to FDAs Bioresearch monitoring system) will be presented. Investigational Review Boards (IRBs) / Ethics Committee (EC) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and compared with GCP and ICH requirements. The differences between the US and EU requirements will be discussed throughout this course. Traditional and Risk-based Monitoring approaches will also be discussed.

Testimonials

"Compared to trainings I've attended with other providers, this course was better due to a well-informed instructor, good course material and presentation. I enjoyed the interaction, videos and examples of actual experience relative to the topics." Linda B., Director, Quality Assurance, Kowa Research Institute
"CfPIE course are all very well organized and concise. Very informative and the class was very interactive." Rose R., Snr. Technical Assoc., Colgate-Palmolive
"The course was very informative and the instructor provided real life scenarios and lots of practical and useful information. It was a three day course and I was totally absorbed from beginning to end." Reena C., Director of Quality, International AIDS Vaccine Initiative
"I found the course to be informative and interesting. I really enjoyed the interaction with the instructor and other attendees regarding specific topics related to my company and experience." Angela C-M., GCP Specialist, Cook MyoSite
"This course has been very helpful! I now have a better understanding of the research world. I will definitely attend another course with CfPIE." Christina – Research Assistant, Johns Hopkins University
"The Course Director did an excellent job! This was one of the best GCP courses I have ever attended!" John M., SVP Quality, CTI Biopharma
"he Course Director's training style is highly engaging and solicits audience participation throughout. His use of anecdotes and experiences is exceptional. His GCP program was the best I have ever attended. Thank you!" Neil C., Dir. Global Med. Affairs. Ops, CTI Biopharma
"Excellent course, good organized training—just excellent" Stanislav B., Senior Medical Manager, Stada Pharm Development
"Our trainer is very experienced and professional, can attract audience's attention and involve each person into discussion. The training is very good — organized, structured and conducted." Vladimir V., Head Clinical & Experimental, Stada Pharm Development
"Was a great overview of GCP - provided practical and real world examples which can immediately be put to practice. The exercises were great, especially the final simulation workshop. The instructor was extremely knowledgeable and engaging. Thanks!" Lynne W., Program Manager, Janssen Pharmaceuticals
"I really enjoyed the course instructor's practical examples throughout the training. I also enjoyed the workshop - great tool to use what you've learned throughout the course." John K. - Audit Manager - Pfizer
"This is great course for all those functions who have a role to play in the GCP arena. The topics for the course were appropriate, touching all the key areas of GCP and the exercises following each lesson were very helpful. The "recap" in the end was also very helpful." Gopi K., VP QA, Adamas Pharmaceuticals
"Course was fantastic! My only wish is it was longer!" Natalie T. - Clinical and Medical Affairs Manager - MELA Sciences
"I enjoyed examples presented by Mike - the Instructor. It is much easier to learn from a person who has real life examples, scenarios." Hanna K., Assoc. Dire. QA, CTI Biopharma
"The three days flew by! A very well organized course, very interactive between the instructor and students. The Course Director was an un-ending source of information and real-life experience. I wouldn't change anything…keep up the good work! I am definitely going to promote this course to others." Natalie B., Clinical Trial Associate, Grunenthal GmbH
"CfPIE has become the gold standard of training providers. I've sent most of my department to this program. It's far better than courses we've attended with other training companies and the Course Note Material is very well put together. I see our employees referring to it time and time again. It's a pleasure to work with an organization that takes such pride in the training they deliver." Dr. Richard P., Director, Pfizer
"The Course Director presented information in a professional and engaging manner. He adequately covered the material information and also challenged the class with real world experiences." Ed R., Sr QA Specialist, CTI Biopharma
"This is my third CFPIE course and each one has been very well organized. After attending this course, we decided to bring the training in-house for our new hires. The instructor was superb and joked about the lengthy process he had to go through to be chosen by the Center. They have the best trainers in the business!" Senior Clinical Manager, Shire Labs
"Excellent course! A comprehensive, worthwhile review of GCP concepts. Plenty of new revelations and real-world examples/exercises. The scope is applicable to all levels of experience. I highly recommend it to anyone involved in clinical research." John R., Project Manager, Ivress, LLC
"The course was excellent! I am a QA Manager for R&D Products only, and this course provided outstanding background knowledge that I can use to better understand how my role integrates with the roles of the Clinical Monitors I communicate with. There was a complete overview of GCPs with great real-life examples. The Course Director is an experienced instructor with extensive industry background, and there were excellent chapter exercises which are good for independent learners." Jeff S., QA Manager, R&D Products
"This course is great for those who are seeking to understand the GCP process and guidelines in details. The workshops are excellent as they are very interactive, which the Course Director encourages." John C., President, Piscium International
"The Course Director was very organized and helpful. He paced the course at a nice speed and encouraged questions. He easily made the course interesting, and the course materials were very useful." Ann L., Administrator, Experimental Medicine, Vifor Pharma

Frequently Asked Questions

Does this course focus on only the GCP requirements of the US or Europe?

This course provides a comprehensive understanding of the GCP requirements for conducting clinical trials in the US, EU, India, China & Japan and other ICH regions. The similarities and differences in regulatory requirements are discussed.

Does this course discuss Risk Based Monitoring?

Yes, both Traditional and Risk Based Monitoring are discussed and compared. The development and implementation of a study specific Monitoring Plan to support Risk Based Monitoring are also addressed.

Many if not all medical institutions are converting to electronic medical records. Does this course address the impact on monitoring and auditing?

The advent of electronic medical records presents many challenges for monitors and auditors. The impact on the auditing and monitoring process as well as related topics such as eCRF and 21CFR Part 11 are discussed.

RAPS | Regulatory Affairs Professionals Society CfPIE is a Regulatory Affairs Professional Society (RAPS) RA Professional Development provider.

CfPIE is committed to enhancing the ongoing professional development of regulatory affairs professionals and others through appropriate regulatory affairs learning activities and programs.  CfPIE has agreed to follow RAPS-established operational and educational criteria.  Click here for the list of courses reviewed and approved by RAPS.