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Establishing Global Drug Substance And Drug Product 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 are available to assist applicants in setting appropriate specifications for a market application, the information in these guidance 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.
- 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,[link widoczny dla zalogowanych], primarily in regulatory affairs and project management. After completing his Bachelor of Science degree in Chemistry from Miami University,[link widoczny dla zalogowanych], Colin joined The Upjohn Company,[link widoczny dla zalogowanych], 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,[link widoczny dla zalogowanych], 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
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