Offered by SSCI, A Division of AMRI, we are pleased to offer the 2017 Pharmaceutical Solids Short Courses
“Pharmaceutical Solids: Essential Knowledge and Advanced Concepts”
June 13-14, 2017
Santa Clara Marriott,
2700 Mission College Boulevard
Santa Clara, CA
September 6-7, 2017
The Grand Summit Hotel
570 Springfield Avenue
A Two-Day Learning Opportunity Awaits You
Whether you’re a seasoned drug development professional or a newcomer to the industry, SSCI continues its commitment to sharing its industry-leading knowledge and mastery of solid state chemistry with you. Process chemists, engineers, materials scientists, intellectual property attorneys and professionals in related fields all stand to gain benefits from this dynamic overview of solid state chemistry.
An all-inclusive, value-packed fee covers this two day course, where you will be learning from the experts, including our solid state chemistry scientist and, renowned IP specialist, Eyal Barash. They are among the knowledgeable SSCI professionals who will bring you up to date on the latest advances in solid state chemistry, with a focus on solid state chemistry ideas, issues, language and methodologies to enable faster drug development. Take advantage of this learning opportunity that will explain why it’s so important to design stable drug products early in the process.
During the short course, you will have the opportunity to meet with SSCI experts for brief discussions and free consultation. If you would like to arrange for a meeting before the short course to discuss your actual data, we can arrange a meeting with the assurance of a Confidential Disclosure Agreement. Send your request for a confidential meeting to David Engers (firstname.lastname@example.org).
Pharmaceutical Solids: Essential Knowledge and Advanced Concepts
with special emphasis on:
- Basic Concepts
- Advanced Analytical Issues — Mixtures
- Chemical and Physical Stability
- Regulatory Issues
(Subject to change)
-Patricia Andres, PhD – Director, Particle Engineering
-Steef Boerrigter, PhD – Senior Research Investigator
-Richard McClurg, PhD – Research Fellow
-Jon Selbo, PhD – Director, Preformulation
-Patrick Tishmack, PhD – Director, Analytical Method Development and Biochemical Analysis
-Eyal Barash, JD, Chief Patent Counsel to SSCI
-Professor Steve Byrn, SSCI Founder & Charles B. Jordan Professor of Medicinal Chemistry, Purdue University
This two-day course is aimed at professionals in the field of pharmaceutical solids who would like to expand their knowledge base. The course provides information which enables faster drug development and quality by design. Presenters will discuss strategic approaches to understanding and predicting the properties and pharmaceutical behavior of solids, as well as the important area of regulatory aspects of pharmaceutical solids including Process Analytical Technologies and risk-based GMPs. Participants will each receive Solid-State Chemistry of Drugs (Byrn, Pfeiffer & Stowell, 2nd Edition) as well as a course notebook.
The course will consist of two all-day presentations and will meet from 8 am to 5 pm.
The course will address the following questions:
- When are polymorphs important?
- What types of studies are required to characterize polymorphs?
- What information can be gained from single crystal X-ray structure determination?
- What should be done to characterize amorphous solids?
- How can stability and rates of transformation be analyzed and predicted?
- How is the polymorph or hydrate present related to stability?
- What specifications should be set and how can analytical procedures for mixtures of solids be developed and validated?
- What is required in a regulatory submission (Q6A) and how should it be approached?
- How can Process Analytical Technology (PAT) be integrated into a solid-state program?
This fundamental course on pharmaceutical solids provides a fast-paced, cutting-edge overview of the ideas, issues, language, and methodologies of pharmaceutical solid-state research. Professionals from many diverse backgrounds are being recruited into the pharmaceutical industry, including process chemists, engineers, materials scientists, pharmaceutical scientists, and many others. The course will help these professionals integrate more quickly into the pharmaceutical industry and work more effectively as colleagues and managers.
Pharmaceutical Solids: Introduction
Basic Definitions and Introduction
Polymorphs and Hydrates
Amorphous Forms and Water
Role of Solid-State Studies in the Drug Industry
Essential Knowledge: Basic principles, structures, space groups, unit cells, symmetry, crystal packing, computer programs, prediction and calculation of powder patterns
Chirality and Amorphous Structures: Space groups, structures, spontaneous resolution
Emerging Capabilities in Crystal Engineering
Crystallization and Control of Crystallization
Hydrates and Clathrates
Characterization of Hydrates/Solvates
Disorder of Solvent Molecules
Prediction of Hydrate Behavior Based on Structure
Structure, Thermodynamics, and Dynamics
Assessment of Disorder in Solids
Advanced Analytical Issues and Process Analytical Technology (PAT)
X-ray Powder Diffraction
Dissolution Testing and Stability
Advanced NMR, IR, and Raman Spectroscopy
Advanced Topics and Regulatory Aspects of Mixture Analysis
Water Sorption Isotherms
Process Analytical Technology and Its Applications in Solids Analysis
Strategic Approaches to Regulatory Considerations
Overviews of Q6A and BACPAC
Quality by Design – Risk-Based GMPs
Reducing Time to Market
Chemical and Physical Transformations
Mobility and Physical Transformations of Amorphous Forms
Rates of Water Uptake and Loss from Hydrates
Motion, Chemical Transformations, and Solid-Solid Reactions
Summary and Stability Prediction
To register, please use our registration form. You may also mail or fax in your registration form (see contact details below). Since registration at each session is limited to forty participants, please register early! A course outline and directions to your hotel will be mailed with confirmation of your registration.
The fee includes taxes, luncheons on all days, beverage breaks, books, and course notes. You may pay for the course using a credit card, check, purchase order. Government employees may contact SSCI to ask about discounted fees. Please note that the cost of your hotel room is not included in the course fee. You are responsible for making your own hotel reservations.