Meeting Regulatory and Technical Requirements for Organic Impurity Analysis:
Produced by Pharmaceutical Technology Magazine.
Organic impurities cover a wide spectrum of compounds that have varying structures, behaviours, and characteristics. Organic impurities can result from manufacturing, storage conditions, or degradation resulting from light, heat, and other external factors. Deciding what technology or analytical methods to use to detect and measure organic impurities is a challenge. This 60-minute webcast will provide insight on regulatory, compendial, and ICH requirements on organic impurity control and analysis. Learn from leading experts on best practices in analytical method development, method selection, and method validation for detecting and quantifying organic impurities in drug substances and drug products.
Tim Watson, PhD
GCMC Advisory Office
Mark Argentine, PhD
Senior Research Advisor
Analytical Sciences R&D
Hildegard Brümmer, PhD
Operational Laboratory Manager
SGS Life Science Services, Berlin
Biosimilars: Landmark Developments Point to the Future for Regulations and Analysis:
Produced by Outsourcing Pharma.
2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity.
This webinar will review the evolution of biosimilar regulations and their impact in the EU, US, and the rest of the world. Additionally, appropriate strategies for primary and higher order structure determination to demonstrate biosimilarity will be discussed, particularly for antibodies where their size and complexity requires LC/MS/MS approaches.
Dr. Fiona Greer
Global Director, BioPharma Services
SGS Life Science Services
Dr. Hoss A Dowlat
Vice President, Regulatory Affairs, Global Strategy