2018 DIA China MASTER CLASS ON BIOSIMILARS: Executive Perspectives on Development, Regulatory and Commercial Aspects

Overview

This course focuses on the RA of biosimilars in Europe and US. International experts are invited to share rich experiences on the RA of biosimilars in Europe and US and give the case studies. The intensive cases will make students understand Europe and US the latest trend and clinical/non clinical requirements, etc., help local companies on international RA strategies and learn detailed practices.

Who should attend?

Managers, Directors, Vice Presidents interested planning or actively working on biosimilars, also, and/or biologics/biotech medicines
Business development
Business Strategy and Operations
Regulatory affairs; EMA, FDA and international
Commercial Affairs
Portfolio Management
Pricing and Reimbursement
Heads of R&D
Scientific Affairs
Drug Safety and pharmacovigilance
Marketing and Sales
Intellectual property
Product development
Chemistry, manufacturing and control, development, QC & QA
Quality and pharmaceutical development
Clinical development/Medical Affairs
Nonclinical development

Learning objectives

An overview of the biosimilars ad biologics progress in the EU and USA, and certain “rest of the world” countries
Examine change of mindset in the US (since 2012) or EU (since 2006)
Insights into EMA and FDA Biosimilars, also new Biologics, development and regulatory framework;
also, approval requirements will be compared and contrasted
Gain understanding of scope of comparability vs. similarity requirements, equivalence from clinical and nonclinical standpoints, significance of bioequivalence studies, circumstances of clinical waivers and reliance on bridging studies
Compare and contrast mindsets, guidelines and experience
Acquire knowledge of general progress and penetration of biosimilars

Program Committee

Hoss A Dowlat, PhD Vice President, Regulatory Affairs EU-USA, Global Strategy
PharmaBio Consulting (Life Sciences), Germany
Weining HU VP of Global Regulatory Affairs
Gan & Lee Pharmaceuticals, China
Joe Zhang Co-founder and CEO
BJ Bioscience Inc., China
Carol Zhu, MBA Vice President, Portfolio and Project Management
JW Therapeutics, China

Digital Learning Catalog

Download