ComplianceOnline

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

Instructors: Suzanne Davis, Colin Davis
Product ID: 701842
  • Duration: 75 Min

recorded version

$299.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$499.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Learn how to establish global drug substance and drug product specifications that are appropriate to the phase of clinical development and market application, and understand the types of data that are needed to support these specifications.

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.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Pharmaceutical development project teams
  • Regulatory Affairs
  • Quality Assurance
  • Analytical and formulation development
  • Emerging pharmaceutical companies

Instructor Profile:

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.

Topic Background:

Drug substance and drug product specifications are key elements of the Chemistry, Manufacturing and Control (CMC) section of a clinical trial or market application, and are often a hot topic during a regulatory review cycle. The amount and types of data needed to support specifications have evolved over the years consistent with improvements in analytical methodology, advancements in toxicological information, availability of information technology tools, and changes to compendial and regulatory requirements. In addition, the ever increasing competition in the industry and need to be first to market has placed greater emphasis on shortened development timelines, while the need to control cost has created a need for more efficient and cost effective development programs. All of these factors have made an impact on the specification setting process. Pharmaceutical firms must keep up with current global regulatory issues, as well as come up with innovative ways to shorten the time to first in human while maximizing knowledge gained during their development program.

Each drug substance and pharmaceutical dosage form comes with its own unique set of attributes and specifications. In addition to the universal specifications set forth in ICH Q6A, additional controls are required that are important to ensuring the safety, functionality, and elegance of your particular pharmaceutical product. It is utmost important to learn what and how 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.

Finally, pharmaceutical scientists must understand the relevant regulatory and compendial requirements for drug substance and drug product specifications and what development studies may be needed to support establishing these specifications. A thorough understanding of ICH impurity thresholds, and knowing when and how to apply them, is a must for developing suitable analytical methodology, designing appropriate toxicology studies, and manufacturing drug substance and drug product for pre-clinical studies and clinical trials. Aside from batch data and stability data, information from pre-clinical and clinical development studies may be necessary to support limits for the drug substance and drug product. For example, toxicology studies may be used to support impurity limits, and bioavailability studies may be relevant to establishing appropriate drug release acceptance criteria. Knowing what types of data are needed to establish meaningful specifications, and knowing early enough in development so that sufficient data are available at time of filing, can prevent unnecessary delays in the overall pharmaceutical development program.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
ComplianceOnline Medical Device Summit 2017

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading