CMC Analytical Comparability Training 2012

Biologics, Biosimilars and Biobetters are considered the growth engine of the pharmaceutical industry. Currently the global market for biologics presents more than $ 130 billion. By 2016, the eight out of the ten blockbuster drugs will go off patent opening up the doors for generics and biosimilars. Becoming a steadily growing new field of biopharmaceutical development and bringing along safety and efficiency challenges, Fleming Europe has organized the CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters.

WHO WILL ATTEND
Vice Presidents, Directors, Heads, Managers and Scientists involved in:
Biologics, Biosimilars, Biobetters, Copy Biologics, Biopharmaceuticals, Biotechnology, Biotherapeutics, Analytical Science, Process Science, Research & Development, Regulatory Compliance, New Product Development, Quality Assurance, Quality Control, Intellectual Property, Clinical Immunology, Scientific Affairs, Business Development, Portfolio Planning, Commercial Affairs, Legal Affairs, Pharmacovigilance, Branded and Generic Drug, Pharmaceuticals & Biotechnology Companies, CROs/CMOs, Drug Regulators, Academic & Government Bodie

The 2-day MasterClass will
• Highlights the regulatory, scientific and technical challenges and opportunities involved
• Provides an opportunity to learn the dos and the don’ts from the experts in this field
• Represents a platform to discuss development challenges, technical hurdles, and regulatory expectations associated with Quality by Design and CMC characterization / comparability studies
• Introduces state-of-the art analytical methods and concepts (analytical characterization of biosimilars and reference product, quality target product profile, aceptable range of variability, justification of differences)
• Presents case studies of originator biologics and biosimilar products including examples addressing the develop