Nicole Sheahan, President of the Global Colon Cancer Association, welcomes attendees to day 2 of the Biosimilars Training Program. Attendees will also meet Kathleen Arnsten, who shares her story as a patient and an advocate.
GCCA's Andrew Spiegel interviews Amgen's Leah Christl, former head of the U.S. FDA's biosimilar program. Dr. Christl recaps what biosimilars are, how they differ from traditional chemical drugs, and highlights key policy issues that affect patients. She also discusses the important role the global patient advocacy community needs to play as biosimilar policy continues to be developed worldwide.
In this presentation, Dr. Ralph McKibbin discusses the controversial practice of Non-Medical Switching and shares new survey data showing high confidence in biosimilars among physicians- and equally strong opposition to forced switching by third parties for non-medical reasons.
Pharmacovigilance (PV) is the post-marketing surveillance of the safety and efficacy of medicines. Biosimilars pose unique PV challenges that can impact patients. Learn why accurate product identification is critical for accurately monitoring adverse drug reactions, avoiding accidental or inappropriate substitution, and promoting manufacturer accountability for their products. Professor Philip Schneider will discuss the various PV systems regulators use to track biologics and biosimilars and discuss problems and potential improvements.
Julien Wiggins of Bowel Cancer Australia will share his perspectives on the Australian biosimilar experience. Learn about Australia's controversial biosimilar substitution policies and hear concerns raised by Australia's patient advocates and physicians.
GCCA President Nicole Sheahan describes the Biosimilars Patient Advocacy Toolkit that all program participants will receive. What’s in the toolkit? Definitions, questions for your doctor, sample position statements for your organization, sample letters to policy makers, and more. Share these materials with your patient advocacy organization in order to be more informed and more effective advocates for the patients you represent.
Four experienced patient advocates reflect on their advocacy successes and offer tips on how to collaborate with allies, identify champions, make clear policy asks, build long-term relationships with policymakers, stay informed and keep your members engaged.
Part 2 of the Biosimilar Training Program concludes with a panel discussion: Three expert advocates highlight several key biosimilars policy issues on which patients and advocacy organizations can engage right now. They also offer tips on how to stay informed about biosimilar policy developments, both in your country and globally.
GCCA President Nicole Sheahan will thank sponsors, speakers, and attendees, and tell participants how they may receive their Training Certificate.
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