2-day In-person Seminar
What is a Clinical Trial, Regulatory Challenges Faced and How to Successfully Manage them?
Time: 9:00 AM to 6:00 PM
Venue: Courtyard by Marriott Atlantic City
**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
This course will start with an introduction to the different types/phases of clinical trials. The different types are intended to test for the safety and efficacy of the treatment in question. The key document in any clinical trial is the study Protocol. The general contents of this document are specified in the FDA Regulations - Code of Federal Regulations (CFR) section 21.
This document is key to everything that goes on during the trial. It is recommended that if you have anything to do with the trial you should review this document. During a clinical trial there can be a number of service groups, like laboratories, pharmacies, and various committees who are in a position to influence the results of the trial. These groups need to understand that they are also covered by the regulations and practices required for the clinical trial.
Another concept that is critical to the conduct of a clinical trial is Quality. Virtually everyone involved in the trial must understand their role in the quality of the results of the trial. This includes things like Quality Assurance, audits, procedures and policies and more.
It is also important to view the Project Management aspects of managing the trial and all of its components. This includes the concepts of Quality Management and Risk Management.
There will be a session that is an introduction to the FDA and current FDA Regulations. It is often important to understand the source of the regulations.
Finally, we will go through using Excel to develop cost estimates for the conduct of the various types of trials. This will include monthly and annual estimates for the various groups involved in the trials.
The Seminar:
This hands on seminar provides a practical approach what Clinical Trials are, what goes into their conduct, and how to manage them and how to estimate the costs associated with conducting a clinical trial.
- Examining the different types of clinical trials and when they are used.
- Identifying characteristics that distinguish various types of Clinical Trials.
- Developing a rationale for scaling activities and effort based upon the type of trial.
- Applying the various Regulatory Requirements.
- Defining necessary operational and management activities.
Why should you attend:
- Clinical Researchers
- Lab Scientists
- Nursing Staff
- Information Technology (IT) personnel
- Quality Assurance
- Management and Laboratory System users
- Hospital Management Staff
- Suppliers of Computerized Systems for EMR/EHR
- Regulators
Industries:
- Pharmaceuticals
- Medical Practitioners
- Nursing Staff
- Medical Device
- Radiological Health
- Blood Products
- Food
- Cosmetics
- Tobacco
- Academia
Day 1 Schedule
Lecture 1:
What are Clinical Trials
- Introduction to a Clinical Trial
- Phase I, II, III, and IV
- Phase 0 and IV
- Key Concepts
- Electronic/Raw Data
Lecture 2:
Study Protocol, IRB and Other Committees
- Clinical Trial Protocol
- Institutional Review Boards
- Drug Safety Monitoring Committees
Lecture 3:
Laboratory, Pharmacy and other Groups
- Clinical Laboratories
- Procedures
- Pharmacies
- X-ray and Other Examinations Procedures, Documentation
Lecture 4:
Quality Assurance During the Trial
- What is QA?
- QA Responsibility
- Quality Management
- Procedures
- Processes
Day 2 Schedule
Lecture 1:
Managing the Trial
- Responsibilities
- Documentation
- Study Start
- Study Execution
- Study Close-out
- Reporting
Lecture 2:
Standard operating Procedures
- Role of SOPs
- Format of SOPs
- Contents
Lecture 3:
The FDA and Regulations
- Historical Formation
- Legal Role of FDA
- FDA Inspections
Lecture 4:
Using Excel to Forecast Costs and Dates
- Default Spreadsheet
- Estimating Resources
- Estimating Costs
- Annual and Monthly
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Group participations
Get fabulous discounts by participating in groups of two or more.| No | Attendees | Discount |
|---|---|---|
| 1 | 2 Attendees | 10% off |
| 2 | 3 to 6 Attendees | 20% off |
| 3 | 7 to 10 Attendees | 25% off |
| 4 | 10+ Attendees | 30% off |
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on 1800 447 9407 to have your seats confirmed!
Richard (Dick) Chamberlain
VP of Compliance, Touchstone Technologies Silicon ValleyRichard (Dick) Chamberlain has provided executive consulting services to numerous Pharmaceutical, Biotechnical, Medical Device companies, and international Contract Research Organizations in the areas of strategic planning project management for the development of computerized project management tools and Computer Systems Validation.
Richard managed large-scale clinical projects from the project planning phase until project closure. He has taught numerous public and in-house courses on various topics such as: Computer Systems Validation, Auditing Computer, Clinical Data Management, Managing Large Scale Clinical Trials, and Project Management. He has conducted and participated in numerous clinical audits for several large multi-national pharmaceutical companies that were conducted in accordance with ICH GCP standards and guidelines. Highly knowledgeable of the various aspects of Computerized Systems and CFR 21, Part 11, FDA Guidelines for Computers, ICH-GCP, and GxPs.
Richard has a Ph.D. and Msc. in Statistics from Iowa State University and a B.Sc.in Mathematics from Wisconsin State.