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Tuesday, June 28 • 2:00pm - 3:00pm
#253: Update from Health Canada

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-613-L04-P; CME 1.00; IACET 1.00; RN 1.00

This forum will provide attendees the opportunity to speak directly to regulators about the current and future state of regulation of biological drugs at Health Canada. The forum will focus on biotherapeutic products (monoclonal antibodies, hormones and enzymes, and cytokines) and will have both clinical and chemistry and manufacturing representation. Specific topics to be discussed will include: changes to the Guidance Document for Subsequent Entry Biologics (SEB), the SEB Scientific Advice Meeting Pilot, risk management considerations for biotherapeutic products, international harmonization, and Health Canada as a flat, flexible, and forward looking organization.

Learning Objectives

Summarize key issues discussed by Health Canada; Identify regulatory hot topics.


Jeffrey Skene, MSc


Jeffrey Skene, MSc

avatar for Agnes Klein

Agnes Klein

Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products, Health Canada
Agnes V. Klein MD is currently the Director, CERB in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in drug development and medical bioethics. SHe represents Canada at ICH and is member of several medical international... Read More →


Jeffrey Skene

Division Chief, Monoclonal Antibodies, Health Canada
Jeffrey Skene has been with Health Canada since 2003. He began his career at Health Canada in Regulatory Affairs and later joined the group responsible for the review of monoclonal antibodies as a CMC reviewer. Today, Mr. Skene is the Chief of the Monoclonal Antibodies Division that... Read More →

Tuesday June 28, 2016 2:00pm - 3:00pm EDT
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 18: Global Regulatory, Forum