ICH Q3D: Elemental Impurities was approved in Dec 2014 with regulations implementing the recommendations taking effect in the ICH regions in June 2016 for new product submissions and Jan 2018 for existing marketed products. The guideline recommends a science and risk based approach to evaluating the potential for inclusion of elemental impurities in drug products. Many different strategies have been developed to comply with the health authority expectations but there still exists some lack of clarity and alignment in industry and regulators alike.
This webinar will provide an overview of the guideline, example approaches to develop product risk assessments and case studies to provide insight into the evolving nature of the implementation of elemental impurity regulations.
- Overview of ICH Q3D: Elemental Impurities
o Foundation in safety assessment of specified elemental impurities
o Elemental impurity product risk assessment
o Proposals for situations in which the PDE is exceeded
- Review of Health Authority guidance and regulations
- Elemental impurity product risk assessments
o Product vs component strategies
o Iterative nature of EI product assessments during the product lifecycle
o Sources of data/information on elemental impurity profiles
o Example EI product assessment formats
- Documentation approaches
o Internal vs submission
- Overview of potential elemental impurity control strategies
- Case studies
o Internally manufactured product
o Product manufactured by third party manufacturing
o Product for which the PDE is exceeded
- Open forum – Q&A
Speaker: Mark G. Schweitzer, Ph.D.
Dr. Schweitzer is the Global Head, Analytical Science & Technology, Novartis Technical Operations Quality In this role, he is responsible for the development and implementation of strategic initiatives in pharmaceutical analytical chemistry, technology development, and analytical process improvements across Novartis. During his career spanning over 30 years, Dr. Schweitzer has led analytical and formulation development groups for several major pharmaceutical (Abbott/AbbVie, Searle/Pharmacia/Pfizer) and private research organizations supporting pharmaceutical development. He has successfully delivered analytical support across the range of development programs, from early stage/FIH to technology transfer to manufacturing.
Dr. Schweitzer received his Ph.D. in chemistry from The Ohio State University in 1984 He is active in several external organizations including PhRMA, ICH, and USP. He served as the vice-chair and chair of the Analytical Technical Group within PhRMA; served as the rapporteur for ICH Q3D: Metal Impurities Expert Working Group through step 2b;is currently the PhRMA topic lead for the ICH Q3D(R1) Expert Working Group; and is the current Vice-Chair of the USP Chemical Analysis Expert Committee.
|Student Ticket:||$100.00||— Sold Out|
|Basic Member Ticket:||$180.00||— Sold Out|
|Pro/Pro Plus Member Ticket:||$150.00||— Sold Out|