Post Graduate Diploma in Clinical Trial Management

At the conclusion of this training program participants should be able to

• Learn the process for managing biomedical product development for FDA approval

• Gain an in-depth understanding of the clinical trials process through a modular, operations-focus approach

• Acquire project management skills needed to successfully manage human clinical trials

• Gain a global perspective on clinical trials management to better respond to the growing industry across the globe

• Learn how to respond to ethical issues inherent in clinical trials

• Discover how to use statistical methods to monitor clinical trial outcomes and make decisions

• Gain practical knowledge through real-world case studies and team projects in product development

• Learn from instructors with industry expertise in clinical trials management

It is an online post graduate Diploma course. It includes 3 months online sessions

Syllabus:

Course Curriculum includes:

Introduction to Food and Drug Law

• Regulatory requirements in the U.S. for drugs, biologics, in vitro diagnostics, devices, combination products, dietary supplements and cosmetic products

• Regulations in other countries

• Food and Drug Administration’s (FDA) organization, structure and history

• Medical product development process

• Good Clinical Practices (GCP) – standards and regulations, pre-market and post-market

• Requirements and best practices for post market clinical trials

• Ethical concerns and examination of the role of statistics in clinical studies

Setting Up Clinical Trials

A comprehensive overview of

• Types and phases of clinical trials
• Implementation of Good Clinical Practices (GCP)
• Development of clinical study documents
• Interactions with Institutional Review Board (IRB)
• Identification and qualification of study sites
• Insurance requirements and needs
• Statistical considerations in study design
• Ethical issues
• Setting up clinical trials globally
• Investigator and subject matter recruitment issues
• Inclusion and exclusion criteria
• Project management skills and best practices

Managing Clinical Trials

A comprehensive overview of project management issues such as

• Successful management, monitoring and closure of human clinical trials

• Preparing for and managing regulatory agency audits

• Balancing business goals with ethical issues

• Managing regulatory and statistical issues related to data management

• Monitoring best practices, from a global perspective

• Maintaining a budget and schedule to meet business goals

• Crisis management and conflict resolution

Pre-Market Submission Process

A comprehensive overview of the report process for pre-market submission to the FDA, such as

• Development of timelines for submissions

• Project management principles followed by Regulatory Affairs professionals employed in the biomedical industry

• Incorporation of clinical data into product labeling

• Best practices for negotiating with regulatory agencies

• Ethical considerations

• Statistical issues in submissions

• Post-market clinical study scenarios

• Global perspective on the premarket submissions process

• Trial design

• Interim Analysis

• NDA

Teaching Mode

• Electronic copies will be shared to students

• Lecture slides in PowerPoint format, as used for on-campus classes, made available for Online sessions

• Additional notes arising from on-campus lectures and tutorials will be shared via mail

Weekly and Monthly Evaluation

• Test paper will be shared with the candidates on weekly basis and Monthly basis

• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis

Additional Features of the course

• E books and SOP’S will be shared via mail to the candidates

• Recent updates of clinical research will be provided to the students via mail

• A feedback barometer, through which students are enabled to provide anonymous feedback as to how the subject is progressing on a weekly basis

System Requirement for Students

• The broad band connection (512kbps and above)

• Head Set

• Link will be sent to the students email id, they have to click on the link and get connected