• From approval to clinical use – what are the differences between the US and Europe?
Speaker: Steinar Madsen, Medical Director, Norwegian Medicine Agency
• Clinical and regulatory strategies encompassing the needs of East and West: What are the key features of a truly global development programme?
Speaker: Gerry McGettigan, CEO, Kinesys Consulting Ltd and COO, amp Biosimilars AG (Germany)
• Where are we now and how will we develop? Lessons learned from the first European & US biosimilars
Speaker: Carsten Brockmeyer, CEO, Formycon AG, (Germany)
• Understanding the blurred lines between traditional innovators and generics
Speaker: Andrea Laslop, Austrian Agency for Health & Food Safety
Event speakers 2015 also include top decision makers from Merck Serono SA, Harvest Moon Pharmaceuticals USA, IMS Health, Dr. Reddy's Laboratories, Selecta Biosciences, MedImmune and many more.
Attendees 2015 include confirmed representatives from: Boehringer Ingelheim, Hospira, Janssen, Merck, Samsung Bioepis, Sandoz, Teva Pharmaceuticals, BioOutsource, Fairleigh Dickinson University, FFF Enterprise, Publicis Healthcare Communications Group, Maxcess Managed Markets, Abzena, Wyatt Health Management, Vince & Associates Clinical Research and many more.
Event programme 2015 includes 2 Opening Addresses, 1 Spotlight Presentation, 15 Hand-Picked Case Study Based Presentations, 1 Panel Debate and 2 Exclusive Interactive Workshops. Register today to network with leading biosimilar experts and hear the latest on the evolving regulatory biosimilar landscape, gain understanding on the barriers being faced for market access and commercialization of products through case-study led presentations plus much more.
The event programme also includes 2 interactive half-day post-conference workshops: “A Regulatory Perspective on Biosimilars” (Hosted by Ravi S. Harapanhalli, Ph.D. Principal, FDAPharma Consulting)
and “Development, Regulatory & Commercial Needs for Global Biosimilars “(Hosted by Gerry McGettigan, CEO & Regulatory Expert, and Graeme Deuchar, Product Development Expert, Kinesys Consulting Ltd, and Liz Yamashita, VP, Regulatory & Clinical Affairs, Oncobiologics.)
Places are strictly limited to ensure an interactive dialogue and optimal learning outcome.