Clinical trial regulations in the United States are complex. The U.S. Food and Drug Administration (FDA) has over 3,000 pages of regulations governing clinical trials, including Good Clinical Practice (GCP) guidelines, which can be overwhelming for clinical leaders to navigate. Additionally, The FDA issues numerous guidelines and rule changes annually. In 2022 alone, the FDA issued 165 new or revised guidelines related to clinical trials. Keeping up with these changes requires constant vigilance and resource allocation.
This certified program will equip you with an in-depth understanding of the clinical trial regulatory framework in the United States, providing key insights into critical areas such as regulatory framework of the FDA and ICH, Code of Federal Regulations, Good Clinical Practice (GCP) guidelines, ethical considerations in clinical research, and the management of clinical trial operations. Participants will gain a well-rounded understanding of the latest regulations and best practices in clinical trial management.
Throughout the program, participants will delve into the technical requirements of clinical trial conduct, ensuring they are proficient in areas such as informed consent processes, safety monitoring, data management, and reporting. This program will also cover the legal and ethical principles underpinning clinical research, highlighting the importance of patient rights and the ethical conduct of clinical trials. Furthermore, the curriculum will address the practical aspects of managing clinical trials, including trial design, budgeting, site selection, and patient recruitment.
Throughout the program, participants will also discover how to prepare for FDA inspections, navigate the complexities of regulatory audits, and respond effectively to compliance issues. You will learn practical strategies to ensure your clinical trials are fully compliant with FDA and ICH guidelines, minimizing the risk of costly delays or penalties. The program will also offer best practices for documentation, ensuring thorough and accurate record-keeping, which is essential for both trial integrity and regulatory submissions.
Upon completing the program, you will earn the Certification in U.S. Clinical Trial Management and Regulatory Compliance. This certification will enhance your professional qualifications, demonstrating your expertise in navigating the U.S. regulatory landscape and managing clinical trials with precision and compliance. This industry-recognized certification will also be a testament to your commitment to excellence in the field of clinical research and regulatory compliance.
1 Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
This program will entitle you:
Download Brochure Pricing & Registration- Experience 2 days of instructor-led live training and gain a comprehensive understanding of U.S. clinical trial regulations, including GCP requirements as well as FDA and ICH requirements, Code of Federal Regulations as well as regulatory processes governing clinical trials in the U.S..
- Attain the industry-recognized Certification in U.S. Clinical Trial Management and Regulatory Compliance. This certification will validate your expertise in designing, managing, and overseeing clinical trials that meet the rigorous standards set by the FDA.
- Learn from real-world case studies and best practices in trial management, gaining critical skills in clinical trial design, patient recruitment, safety monitoring, ethical considerations, data management, and regulatory processes to enhance your organization’s compliance and success in clinical research.
- For inquiries, chat with our Program Advisers at [email protected] or call us at
- USA: +1 888 745 8875
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
Accreditations
This program is accredited by the Chartered Institute of Professional Certifications, which maintains the governing standards for all professionals who have completed this program.
The content of this program has been fully certified and accredited by CPD Certification Service as conforming to Continuing Professional Principles. CPD is the leading independent CPD accreditation institution operating across industry sectors to complement the Continuing Professional Development policies of professional institutes and academic bodies. The CPD Certification Service provides support, advice and recognized independent CPD accreditation compatible with global CPD principles.
What Can You Expect From This Live Program
The clinical trial management and regulatory compliance landscape in the United States is not only intricate but also one of the most heavily regulated sectors globally. Navigating through the extensive array of laws and guidelines governing clinical trials can be daunting for even the most seasoned professionals. With over 5,500 clinical trials registered in the U.S. every year, understanding the evolving regulations is crucial to ensuring trial success and compliance. The complexity deepens as regulatory bodies like the FDA continue to introduce new requirements, making non-compliance a costly risk — with fines that can reach up to $1 million per violation.
This certified program is designed to provide participants with a comprehensive understanding of the clinical trial regulatory environment in the United States. You will gain valuable insights into critical areas such as the FDA’s regulatory structure, the International Council for Harmonisation (ICH) guidelines, the Code of Federal Regulations, and the implementation of Good Clinical Practice (GCP). The program goes beyond regulations, emphasizing ethical considerations in clinical research and the sophisticated management of clinical trial operations, ensuring a robust understanding of both legal requirements and practical application.
Participants will explore the intricate technical aspects of clinical trial conduct, mastering key areas such as the informed consent process, safety monitoring, adverse event reporting, and data integrity. In addition, this program will cover the practical aspects of clinical trial management, including trial design, budgeting, site selection, and strategies for patient recruitment—essential for maintaining both scientific rigor and operational efficiency. You will be equipped with the tools to manage clinical trials effectively, ensuring they meet stringent regulatory standards while optimizing timelines and resources.
Furthermore, participants will learn how to prepare for FDA inspections, navigating the complexities of regulatory audits, and effectively managing compliance challenges. This program will arm you with strategies to minimize the risk of non-compliance, avoid costly delays, and ensure that your clinical trials adhere strictly to FDA guidelines.
Upon successful completion of the program, participants will be awarded the Certification in U.S. Clinical Trial Management and Regulatory Compliance. This certification will enhance your professional qualifications and demonstrate your critical knowledge in navigating the complex landscape of U.S. clinical trial regulations and compliance requirements. This industry-recognized certification is also a lifelong endorsement of your expertise and dedication to excellence in clinical research and regulatory affairs within the U.S. healthcare and pharmaceutical sectors.
Key Skills You Will Gain
- Clinical Trial Oversight
- FDA Regulatory Knowledge
- Ethical Considerations in Trials
- Code of Federal Regulations (CFR)
- Good Clinical Practice (GCP) Application
- Clinical Protocol Development
- Investigators’ Brochure Management
- Endpoints and Statistical Design
- Decentralized Clinical Trials (DCT) Management
- Digital Health Technologies in Trials
- Real-World Evidence (RWE) Integration
- Adverse Event Reporting
- Data Safety Monitoring Committees (DSMC)
- Clinical Investigator Responsibilities
- Institutional Review Board (IRB) Protocols
- Informed Consent Compliance
- Quality by Design (QbD) Implementation
- Clinical Data Interchange Standards (CDISC)
- Data Collection and Management
- Case Report Form (CRF) Development
- FDA Inspection Preparation
- Clinical Trials Registration
- Post-Marketing Surveillance
- Safety Monitoring in Trials
- Risk Management Planning
- Periodic Safety Update Reports (PSURs)
- Signal Detection in Trials
- Safety Reporting Standards
- FDA Inspection Readiness
- Data Sharing and Results Reporting
Your Faculty Director
Dr. Jayanthi is a highly regarded leader in the pharmaceutical industry with deep expertise in regulatory affairs. She currently heads the regulatory affairs and quality assurance department at a Boston-based biotechnology firm focused on developing innovative treatments for infectious diseases. Her career spans leadership roles in biotechnology and major pharmaceutical companies, where she contributed to the successful development of several breakthrough medicines. Notably, she served as the global regulatory team leader for ERVEBO®, the first Ebola vaccine approved by the FDA, EMA, and prequalified by the WHO.
Jayanthi holds a Ph.D. and master’s degree in Molecular Biology and Immunology from Princeton University, along with a B.S. in Biochemistry from Susquehanna University. She has been recognized with several prestigious awards, including for the approvals of KEYTRUDA® and GARDASIL-9®. Jayanthi is an active member of the Society of Toxicology, the Regulatory Affairs Professional Society, and serves on the Biotechnology Innovation Organization's Regulatory Affairs Steering Committee.
U.S. Clinical Trial Management and Regulatory Compliance Program Agenda
How You Will Benefit From This Program
- Master U.S. Regulatory Framework: Gain comprehensive knowledge of FDA regulations and the Code of Federal Regulations (CFR) governing clinical trials.
- Ensure GCP Compliance: Learn how to implement Good Clinical Practice (GCP) guidelines across all phases of clinical research.
- Develop Robust Clinical Protocols: Understand the essentials of designing and managing clinical trial protocols, including statistical endpoints.
- Manage Clinical Trial Operations Effectively: Acquire practical skills in trial design, budgeting, site selection, and patient recruitment to optimize clinical trial performance.
- Enhance Safety Monitoring: Master adverse event reporting and safety monitoring procedures to maintain patient safety.
- Prepare for FDA Inspections and Regulatory Audits: Learn how to effectively prepare for FDA inspections and ensure compliance with their expectations.
- Master Data Management and Safety Monitoring: Understand the technical requirements for data integrity, safety monitoring, and adverse event reporting in clinical trials.
- Leverage Risk Management Strategies: Develop Risk Management Plans (RMPs) and enhance your ability to manage trial risks effectively.
- Navigate Ethical and Legal Responsibilities: Deepen your understanding of ethical and legal obligations in U.S. clinical trials, including informed consent and IRB approvals.
- Optimize Quality by Design (QbD): Learn how to build quality into clinical trials from the start, ensuring high compliance and efficiency.
Certification in U.S. Clinical Trial Management and Regulatory Compliance
Upon successfully attending this program, you will be awarded with the Certification in U.S. Clinical Trial Management and Regulatory Compliance that can be used in your resume, CV and other professional credentials. This certification is industry-recognized with lifelong validity.
Globally recognized and highly sought after, the Certification in U.S. Clinical Trial Management and Regulatory Compliance will elevate your professional credentials and showcase your expertise in navigating the intricate landscape of U.S. clinical trial regulations. It will validate your ability to develop and implement a robust compliance framework that ensures your organization's clinical trial practices align with FDA standards and Good Clinical Practice (GCP) guidelines. Developed by the Chartered Institute of Professional Certifications, this program has been independently accredited by the CPD Certification Service, ensuring it meets the highest standards of continuing professional development principles.
Pricing & Registration
United States
Dates: 1 - 2 Jul 2025
Venue: Online Executive Program (via Zoom)
Time: 8:00am - 3:30pm Pacific Daylight Time (PDT)
10:00am - 5:30pm Central Daylight Time (CDT)
11:00am - 6:30pm Eastern Daylight Time (EDT)
| Early Bird Packages | Regular Pricing | ||
|---|---|---|---|
| By 28 Apr 2025 | By 09 Jun 2025 | After 09 Jun 2025 | |
| USA Delegates | USD 1,395 | USD 1,595 | USD 1,695 |
Group Discount: 2nd participant get 10%, or register 3 participants and 4th participant get a complimentary seat (1 discount scheme applies)
Register NowDownload Brochure
You can download our program brochure below. If you have any inquiries on this program, please contact our Program Advisor at [email protected] or call us at:
- Singapore and Asia Pacific: +65 6716 9980
- Australia and New Zealand: +61 3 9909 7310
- UK, Europe and Middle East: +44 (020) 335 57898
- USA: +1 888 745 8875
U.S. Clinical Trial Management and Regulatory Compliance Reviews and Testimonials
Chartered Institute of Professional Certifications' reviews and ratings are a comprehensive collection of participants feedback we have gathered over the last decade. To view authentic and personal testimonials that are handwritten by our participants, please download our participants' written reviews here.
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U.S. Clinical Trial Management and Regulatory Compliance
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