Regis Technologies, Inc.

Dr. Steven Baertschi delivered this talk in South San Francisco, CA on October 31, 2018. Development and implementation of impurity control strategies is a complicated, yet critical process necessary to ensure overall pharmaceutical product quality and patient safety.  Existing guidelines for control of new impurities in drug substances and new drug products (ICH Q3A/Q3B, USP Chapters 476 & 1086) apply to commercial products or products in late-stage clinical development (Phase 3). In addition, guidance for mutagenic impurities (ICH M7), which covers early clinical development through commercialization, is a relatively new guideline and questions regarding its implementation remain. The lack of regulatory guidance regarding impurity controls at early stages of clinical development (prior to Phase 3) provides both questions and opportunities for the development of effective control strategies. This talk focuses on risk-based, chemistry-driven approaches to speeding the development of organic impurity control strategies throughout clinical development. Relevant examples and references are provided.

Speeding Drug Development through Impurity Control Strategies

Filing an Investigational New Drug (IND) application with FDA is a milestone for emerging pharmaceutical companies seeking to gain approval for clinical testing of innovative new therapies. The IND application process must be thorough and by the book; collecting and reporting the supporting chemistry, manufacturing, and control (CMC) information can be stumbling blocks in the path to IND approval.

This webcast is designed to help guide small- and mid-size pharma companies through the steps required to prepare the chemistry and manufacturing process information expected by FDA in an IND application. While the focus is on novel small-molecule therapeutics, the elements discussed will be useful background for large-molecule programs as well.

Experts discuss the application process and communications with FDA; identify required information about the quality, purity, strength, preparation, and stability of the drug substance and drug product; and explain the crucial analytical methods and validation processes needed for a successful filing.

Presented by PharmTech. Sponsored by Regis Technologies. Speakers include Carol H. Danielson, MS, DrPH (President of Regulatory Advantage International LLC), Sharon W. Ayd, PhD, MBA (Chief Scientific Officer and Sr. VP Pharmaceuticals of Regulatory Compliance Associates, Inc.), and Daniel Weissmueller (Director of Quality of Regis Technologies).

Strategies for IND Filing Success

Jason J. Orloff, a chemical engineer and international consultant with over 15 years in the industry, gave a technical talk at Regis regarding pharmaceutical quality culture. The talk assesses quality initiatives in the pharmaceutical industry and answers the questions, "Where does process capability belong? As a compliance reportable? Or as a self-audit of performance done by manufacturing for senior management to prioritize continuous improvement?"

Regis Technologies, Inc.

Home

Videos

Playlists

About

Keep up to date with all your favourite videos and channels.

Get personalised notifications on new releases and channel content by subscribing to the LabTube eNewsletter.