Establishing Global Drug Substance and Drug Product Specifications - What the Guidelines Don't Tell You

Why Should You Attend:

Establishing appropriate specifications for the drug substance and drug product at the various phases of clinical development can be a challenging task. While regional and ICH guidance’s are available to assist applicants in setting appropriate specifications for a market application, the information in these guidance’s do not necessarily reflect the appropriate level of control needed for early phase clinical studies. Too many or too tight controls established early in development can create unnecessary problems or delays and increase development costs, while insufficient controls may result in clinical holds.

This session will provide instruction on knowing what to file with the regulatory agencies and when in order to maximize the success of your drug development program. You will learn how important it is to have a thorough understanding of the critical quality attributes of the drug substance and drug product to not only improve your ability to make meaningful decisions during development, but also to be able to establish and justify suitable specifications for your dosage form. This presentation will cover the relevant ICH and compendial requirements and what data is needed to support your drug substance and drug product specifications.

Areas Covered in the Seminar:

• ICH guidelines and other relevant sources for setting specifications.
• Recent changes in compendial requirements.
• Minimum requirements for drug substances from Phase 1 through market application.
• Minimum requirement for drug products from Phase 1 through market application.
• Specifications specific to various types of dosage forms.
• Regional differences in specifications.
• Data requirements for setting meaningful acceptance criteria.
• ICH thresholds.
• Impurity qualification.
• Potential pitfalls due to insufficient or inappropriate specifications.

Colin Davis, has over 30 years of experience in the pharmaceutical industry, primarily in regulatory affairs and project management. After completing his Bachelor of Science degree in Chemistry from Miami University, Colin joined The Upjohn Company, where he remained employed with Pharmacia and Upjohn, Pharmacia Corporation, and Pfizer, Inc. After leaving Pfizer, Inc. in 2005, he gained additional experience in the generic pharmaceutical industry working as an Associate Director of Regulatory Affairs for Hospira, Inc. and The Perrigo Co. Throughout his career Colin has held positions in analytical methods development, cGMP compliance, project management, and CMC regulatory affairs. In his position as Director of CMC Regulatory Affairs for Pfizer, Inc., Colin managed regulatory scientists in the preparation of CMC registration documentation, participated on global development teams, and spearheaded various initiatives for improving organizational performance and global quality standards. Colin has authored various internal documents on specifications and provided numerous presentations on this topic throughout his career in industry

Suzanne Davis, has over 20 years of experience in the pharmaceutical industry. After obtaining a Bachelor of Science in Chemistry degree from the University of Michigan, she began her work in Kalamazoo, Michigan at The Upjohn Co., where she remained employed with Pharmacia and Upjohn, Pharmacia Corporation, and Pfizer, Inc. until leaving in 2005 to utilize her regulatory affairs expertise in consulting. Suzanne has held positions in analytical methods development, project management, and CMC regulatory affairs. She has considerable experience in both consumer and animal health CMC requirements in addition to her expertise on new chemical entities and in recent years have gained experience in CMC requirements for biologics. Her years of experience in regulatory affairs also include human health clinical trial and market applications, management of a global CTD template change control team, and participation in process improvement teams and regulatory affairs infrastructure initiatives.