Industries: Pharma / Biotech

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

Course Director: Michael R. Hamrell, Ph.D.

 

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 - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

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, regulatory requirements.  The course consists of lecture and exercises designed to focus on the 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 quality in clinical trials.  Participants will also discuss real life situations such as reviewing pre-study documents and informed consent form for completeness and compliance; conducting drug accountability; reviewing case report form for accuracy and adherence to protocol and performing source document verification.

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 good clinical practice certification course work are practical examples for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and case studies.  The GCP training course will also provide the attendee with thorough knowledge of the following topic:

  • How drugs/biologics and devices are discovered and developed
  • The different phases of clinical research
  • What constitutes Good Clinical Practices (GCP)
    • How the requirements differ in the US, EU, India, China & Japan
  • 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 and ICH Guidelines govern conduct of clinical studies
  • The purpose for an IND / CTA and its composition
  • 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
  • How to perform product Accountability & compliance
  • How to detect and deal with potential fraud and misconduct
  • The purpose and composition of the marketing application
  • How marketing applications are filed, reviewed and approved
  • Sponsor responsibilities after approval
  • What happens during a FDA inspection

Who Should Attend

This three-day good clinical practice certification course is specifically designed for Clinical Operations Staff (Study Managers, Medical and Study Monitors) as well as GCP Auditors and others involved in conducting and monitoring and/or QA of clinical studies of new medications who require a working knowledge of the regulatory requirements (US and EU) and ICH Regulations for Good Clinical Practices (GCPs).  This three-day program will provide attendees with the training needed to improve clinical trials and ensure compliance with Good Clinical Practice, FDA Regulations, EU Directives and ICH Guideline.   

Clinical Research Managers and employees who work for Pharmaceutical or Biological firms, Contract Research Organizations, Medical Device companies and academic institutions involved with the supervision or oversight 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 GCP training program.

Course Agenda

First Day

9:00am – 9:30am - Introductions & Review of Agenda

9:30am – 10:30am - The Product Development Process

  • Overview of Development
  • Stages of drug development
  • Phases of clinical development

10:30am – 10:45am - Break

10:45am – 12:00pm - Good Clinical Practice (GCP)

  • Principals of GCP
  • Role of IRB/IEC, sponsor, investigator

12:00pm – 1:00pm - Lunch

1:00pm – 2:00pm - Regulations

  • History of Regulations
  • 21 CFR, EU Directive
  • ICH Guidelines
  • Role of Regulatory Agencies
  • Overview of differences in GCP between US, EU, India, China, Japan

2:00pm – 3:00pm – IND/CTA

  • Definition
  • Types of INDs/IDEs & CTAs
  • Review & amendment process

3:00pm – 3:15pm - Break

3:15pm – 4:30pm - IRB/IECs

  • Description, composition & role
  • Study review and approval process

4:30pm - 5:00pm - Recap, Questions and Answers

Second Day

9:00am – 10:30am - Informed Consent

  • Elements of informed consent
  • Process
  • Review, approval, amendments

10:30am – 10:45am - Break

10:45am – 11:30am - Monitoring

  • Definition
  • Types of monitoring visits & tasks
  • Role of the Study Monitor
  • Risk Based Monitoring
  • Monitoring follow-up

11:30am – 12:30pm - Adverse Events

  • Definitions
  • Documenting
  • Reporting (US vs. EU)

12:30pm – 1:30pm - Lunch

1:30pm – 2:45pm - Drug Accountability

  • Definition
  • Managing clinical supplies
  • Compliance

2:45pm – 3:30pm - Fraud & Misconduct

  • Maintaining accurate records
  • How to detect fraud & misconduct/li>
  • Misleading data and results
  • Implications and consequences
  • Examples of fraud

3:30pm – 3:45pm - Break

3:45pm – 4:30pm – Fraud (continued)

4:30pm – 5:00pm – Recap

  • Questions and answers

Third Day

9:00am – 9:30am - Post Drug Approval

  • Reporting requirements
  • Post-approval safety reporting
  • Phase IV studies

9:30am – 10:30am - Electronic Systems and Data Management

  • Complying with 21 CFR Part 11
  • FDA guidance on electronic systems
  • Use of EMR
  • Issues with electronic data capture, CRFs and medical record systems

10:30am – 10:45am - Break

10:45am – 12:00pm - Preparing for FDA Inspections

  • Preparing for the visit
  • FDA criteria for selecting sites for inspection
  • Source documentation
  • Common GCP deficiencies
  • Identifying potential problems early
  • Review potential roadblocks of non-compliance
  • Recent BIMO inspection results
  • Inspection findings and tredns

12:00pm – 1:00pm - Lunch

1:00pm – 2:30pm – Collecting, Managing and Reporting Clinical Study Data

  • Computerized clinical data management
  • CRFs vs. eCRFs
  • How much clinical data is enough
  • Making sure your records and reporting are accurate

2:30pm – 3:30pm-Course Review & Recap

  • Questions and Answers
  • Course Evaluation

Learning Objectives

Upon completion of this course, each participant will have a thorough understanding of the latest updated GCP requirements for monitoring and oversight of clinical trials described by FDA, global Regulators and ICH and ISO Requirements for Sponsors, Monitors, and Investigators. In addition, the significance of these regulations will be correlated to protocol and case report form development 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) and Informed Consent (IC) as required by the FDA and ICH regulations are discussed in detail and compared with GCP and ICH regulations.

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.