Course Description:

The cost of FDA non-compliance is significantly more than the cost of compliance. Are you in compliance with the FDA regulations for new drugs?

Charlene M. Jett is experienced in clinical research of pharmaceuticals. She will discuss drug development as a serious costly process and clinical research the most costly and critical aspect of the business. FDA's monitors the safety and efficacy of all drugs. Only the highest ethical standards are acceptable in this very serious business. Any and all results are documented and reported regardless of whether they are positive or negative. This is at a huge cost of time and money to the pharmaceutical companies. Examples of two successful drugs developed, approved by FDA and marketed will be used as examples.

Typical proactive steps to prevent problems and solving actual problems found in drug development will be discussed. Whether protocol problems, side effects in patients, computer or documentation problems, there are very strict guidelines to correct the problems. All the details must be reported to the FDA, medical monitors and directors in charge of the project. If the process is new to the company or a well established pharmaceutical company, all the problems must be solved. The intensity and level of scrutiny involved depends on the level of risk to the patient and amount of money involved.

In this two day workshop conference you will learn:

  • The basics of clinical research and how it is done by the pharmaceutical companies and impacted by FDA.
  • Methods of problem prevention and solving in order to develop and implement solutions that are accepted, effective, and efficient will be exemplified by using two example drugs that were approved by the FDA.
  • These discussions will provide thoughts and ideas to improve the performance of your current project.
  • Management practices can help or hurt your drug and project, ruin your reputation and stock price.

Learning Objectives:

Upon completing this course participants should:

  • Understand how pharmaceutical companies and FDA work together.
  • Learn how to utilize good management practices to identify and implement the main ingredients for problem prevention. Establish and comply with the highest ethical standards, necessary to create a successful project.
  • Create and establish good communications and problem prevention
  • Establish methods to track and monitor successes and problems
  • Develop successful marketing, research and project management plans
  • Perform financially viable assessments of clinical protocols

Who will Benefit:

This course is designed for people tasked with developing a new drug whether in a large or small company. Following personnel will benefit from the course:

  • Sponsors of pharmaceutical companies
  • Investigators and co- investigators
  • Clinical research professionals, study coordinators
  • New doctors, medical directors, scientists and health care workers
  • Quality, regulatory and compliance professionals
  • Production, manufacturing, design professionals
  • Document control and record retention specialists
  • Project managers, marketing professionals
  • Legal professionals

Topic Background:

The average cost for a new drug to be developed in the USA is 1-2 billion dollars, with a timeline of 5-7 years for approval. FDA inspections, site visits, patient and/or investigator problems all add to the cost and lengthen the time line. Correcting even the most minor problems usually requires 10 time the effort, that would normally have been required if no error had been made. In other words, an ounce of prevention is worth a pound of cure! Occasionally if the problems are new added resources for consultants, personnel, remediation of records, etc may be required. This cost estimate does not even include the ramifications of deaths, product recalls or holds, cost of not going to market with a new drug, or delays in FDA IND and NDA approvals as a result of their inspections and visits. Large pharmaceutical companies require 4-5 approvalable NDAs each year to stay in business.

Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

  1. Introduction and Thumbnail: Overview of Basic Clinical Research: On time and Under budget- Seminar
  2. Pharmaceutical Companies and FDA Structure and Functional Roles
  3. People and Project Management - Departments, Roles and Responsibilities
  4. Regulatory vs the FDA: Continuous Interactions: INDs and NDAs
    1. Main ingredients of a good research management system
    2. Details of a good clinical research plan and a good project plan
    3. Discovery, marketing and manufacturing plans

    NOON-LUNCH BREAK- 30 minutes

  5. Pushing the project team forward: Deadlines: On-time and Under budget, ROI
    1. Problems and solving problems
    2. People, process, tools
  6. How to handle the FDA - don't try!
  7. Legal and risks - risk benefit ratio, claims, patient protection, lawsuits

  1. Protocols, Consents, Contracts, Investigators, IRBs, Patients
    1. Clinical Trial Monitoring and Tracking
    2. Computers and data analysis
    3. Site reports, clinical and statistical reports, medical summaries
    4. Site Records and Master Files
    5. Proof of Safety and Effective
  2. Computers and Data Analysis: Security and Analysis
  3. Submission to FDA calls, site visits, discrepancies, submissions, approvals and findings.
  4. Conclusion : Review and Questions

Meet Your Instructor

Charlene M. Jett
President- 3R's Management Consulting and Therapeutics Inc.

Charlene M. Jett is currently President of 3R's Management Consulting and Therapeutics, Inc. She has provided clinical research, regulatory and quality services to the pharmaceutical, medical device, diagnostic and chemical industries. This has encompassed over 30 different companies in 20 years. Charlene was employed by G.D. Searle and Abbott Laboratories for about 17 years. She achieved the positions of Sr. Research Biochemist , Sr. Clinical Research Associate (CRA) and Project Manager. She has worked in the specialties of cardiology, anesthesiology and surgery, anti-infective, rheumatology and cancer, plus others. She has written numerous protocols, consents, monitored clinical trials, written literature reviews, and medical summaries. She has created several publications and presentations. She has also taught graduate statistics and ethics; was a caregiver for her mother. Charlene obtained her BS in Physiology(Pre-Med) from the University of Illinois, MS in Biology from Northeastern Illinois University and another MS from Lake Forest Graduate School of Management. She currently is a member of Sigma Xi and the American Chemical Society, where she enjoys their many webinars.

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Local Attractions

Jack London Square is a popular entertainment and business destination on the waterfront of Oakland, California. Named after the author Jack London and owned by the Port of Oakland, it is the home of stores, restaurants, hotels, an Amtrak station, a San Francisco Bay Ferry ferry dock, the historic Heinold’s First and Last Chance Saloon, the (re-located) cabin Jack London lived in the Klondike, and a movie theater.

The lake features grassy shores; several artificial islands intended as bird refuges; an interpretive center called the Rotary Nature Center; a boating center where sailboats, canoes and rowboats can be rented and classes are held; and a fairy tale themed amusement park called Children's Fairyland. The park is also a center for sporting activities, including sailing, canoeing, and jogging along the lakeshore.

In the vast hills outside town, this award-winning Oakland Zoo, features more than 300 types of animals living in carefully-recreated natural habitats, easily making it one of the premier Oakland attractions. The African savannah exhibit is particularly popular, with African plants and a waterfall providing a home for meerkats, monkeys, and hyenas.

The Oakland Museum of California or OMCA (formerly the Oakland Museum) is an interdisciplinary museum dedicated to the art, history, and natural science of California, located in Oakland, California. The museum contains more than 1.8 million objects dedicated to "telling the extraordinary story of California.

Volcanic debris has formed vast mountains in this Oakland park, which covers 660 acres in the Oakland Hills. One of the most famous peaks is Round Top, which is made up of lava and other materials from a volcano said to be 10 million years old.

The Paramount Theatre is a 3,040 seat Art Deco movie theater located at 2025 Broadway in downtown Oakland, California, USA. When it was built in 1931, it was the largest multi-purpose theater on the West Coast, seating 3476. Today, the Paramount is the home of the Oakland East Bay Symphony and the Oakland Ballet, it regularly plays host to R&B, jazz, blues, pop, rock, gospel, classical music, as well as ballets, plays, stand-up comedy, lecture series, special events, and screenings of classic movies from Hollywood's Golden Era.

The Cathedral of Christ the Light, also called Oakland Cathedral, is the cathedral of the Roman Catholic Diocese of Oakland in Oakland, California. It is the seat of the Bishop of Oakland. Christ the Light, the first cathedral built in the 21st century, replaces the Cathedral of Saint Francis de Sales, irreparably damaged in the Loma Prieta earthquake of 1989.

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