Understanding the Statistical Considerations for Quantitative ICH Guidelines: 2-Day Hands-on Workshop

By: Dr. Al Bartolucci Emeritus Professor of Biostatistics, University of Alabama
Location 1:- Tampa, FL
Thursday, March 17, 2016 | Friday, March 18, 2016
Location 1:- San Francisco, CA
Thursday, June 23, 2016 | Friday, June 24, 2016

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Course Description:

This course is designed to introduce to individuals the understanding and interpretation of the statistical concepts with reference to certain quantitative ICH Guidelines that apply across laboratory (drug development) and clinical development (drug/device) procedures such as analytical methods in validation and acceptance criteria in calibration procedures, risk management and process monitoring as well as dealing with uncertainties and other relevant issues. It is not a course in statistics but introduces the participant to a hands on approach to the statistical techniques one uses, how they are applied and reasonably interpreted and understood. One will address the various challenges facing pharmaceutical and biotechnology companies when it comes to quantifying results in a meaningful interpretable manner through tabulations and graphical presentations.

In this two day workshop seminar one will learn the different regulatory agencies expectations of the quantification and development of a sound statistical monitoring of process control that are accepted, effective, and efficient. Participants will become familiar with the important aspects of the statistical methods and learn how organizations are expected to apply these guidelines.

Learning Objective:

Upon completing this course participants should be able to:

  • Evaluate linear and other quantitative measurement procedures.
  • Distinguish the difference between confidence and tolerance intervals.
  • Evaluate the sensitivity of the sample size in given procedures.
  • Evaluate laboratory/clinical data results based on risk management and design space issues.
  • Interpret alternative approaches to statistical process control in reference to data distributional formats.
  • Discuss relevant FDA requirements and ICH guidelines.

Who will Benefit:

This course is designed for people responsible for developing, maintaining and/or improving clinical and laboratory monitoring programs and interpreting the results from such. This includes individuals that have data monitoring responsibilities. The following personnel will benefit from the course:

  • Quality Managers
  • Quality Professionals
  • Assay Development Scientists
  • Research Scientists
  • Clinical/Laboratory Data Analysts
  • Laboratory Data Managers

Course Outline

Day One (8:30 AM – 4:30 PM)
  • 8:30 – 9:00 AM: Registration
  • 9:00 AM: Session Start Time
  1. Course Motivation and Overview of ICH Methodology (Including Q2A, Q2B, Q8 and Q9)
  2. Introduction to the simple regression model
    • Interpreting the role of the slope and intercept in validation/risk procedures
    • Prediction and Residual analysis
  3. Outlier strategies using the linear model in calibration methods
    • Imputation techniques (parametric and Non parametric) for missing data
    • Strategies for non normal data
    • Consequences of outlier data elimination/substitution
    • Updated extreme variance detection strategies
    • Sample size and analysis issues
  4. Confidence and tolerance bounds on risk models
    • Parametric and non parametric (non normal data) procedures
Day Two (8:30 AM – 4:30 PM)
  1. Discussion of risk management in general
    • Risk Management in pre-analytical phase of laboratory testing
    • Traditional risk management strategies in laboratory and clinical settings
    • Discussion of the design space in design/analysis of experiments
    • Response surface and system suitability tests
    • Predictive models in risk assessment
  2. Introduction to validation of models in hazard assessment and risk management
    • Bivariate models and confusion matrices and derived statistics
    • ROC plots
  3. Alternatives to statistical process control and capability
    • Normal and non normal data procedures
    • Simple single variable evolutionary operations procedures
    • Introductory multivariable charting procedures

Meet Your Instructor

Alfred-Bartolucci-90X112
Dr. Al Bartolucci
Emeritus Professor of Biostatistics, University of Alabama

Dr. Al Bartolucci is Emeritus Professor of Biostatistics at the University of Alabama where he also serves as a Senior Scientist at the Center for Metabolic Bone Diseases, AIDS Research Center and Cancer Center.

He previously served as Chairman of the Department from 1984 through 1997. He has also taught Statistical Software courses involving Data Exploration, ANOVA/Regression and Design of Experiments. His teaching experience includes areas such as, Clinical Trials, Survival Analysis, Multivariate Analysis, Regression Techniques and Environmental/Industrial Hygiene Sampling and Analysis, Bayesian Statistics, and Longitudinal Data Analysis.

Dr. Bartolucci received his PhD in Statistics from the State University of New York at Buffalo and his MA in Mathematics from Catholic University, Washington DC, and his BA in Mathematics from Holy Cross.

Publications:

He is widely published with over 300 publications and some of his recent works include:

  • Bartolucci, Al: Bayesian modeling of pharmaceutical data addressing the average effect of bivariate parameters of interest in a bioequivalence framework, page 166, December 2011, Journal of International Modeling and Simulation, Vol
  • Bartolucci, Al: An application of EM algorithm in prostate carcinoma data, page 525, Epidemiology, Health and Medical Research
  • Bartolucci, Al: Meta-analysis of multiple primary prevention trials of cardiovascular events using aspirin, page, American Journal of Cardiology
Location 1:
Tampa, FL (Venue to be announced shortly)

March 17-18, 2016


Location 2:
San Francisco, CA (Venue to be announced shortly)

June 23-24, 2016


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The registration fee includes: the workshop; all related course materials; tea/coffee and lunch on both the days.
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Tampa, FL, Local Attractions

Museum of Science & Industry (MOSI)
More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology.At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.

Salvador Dali Museum
Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art.

Tampa Museum of Art
Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work.

Craftsman House
Craftsman House is a gallery that showcases contemporary art works. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.

San Francisco, CA, Local Attractions

Think Escape Party Bus
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport.

Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.

Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.

City Kayak
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.

Think Escape Casino Tour San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity