Nonclinical and Clinical Safety Assessment of Biosimilars
Part 2 : Regulatory Perspective

Thursday, February 20, 2014 |Archive Now AvailablePrescription drugs

This webinar will focus on EMA and FDA regulatory perspectives on nonclinical and clinical safety assessment in biosimilars..


Regulatory frameworks are evolving many countries to guide a path for biosimilar drug development, however the complex nature of biopharmaceuticals makes the demonstration of biosimilarity with regards to quality, safety and efficacy extremely challenging. Based on the specific aspects of biosimilar drug development and registration, development strategies differ significantly from the development of an innovator product that has to establish both the efficacy and safety independently from other products.

The webinar will review:

• EMA guideline on Biosimilar mAbs-Focussing on future biosimilars
• EMA VS FDA regulation -Including a discussion of WHO guidance
• Regulatory Environment
• Case studies and ongoing challenges


A live Q&A with the audience will follow the main presentation.

Webinar Speaker:









Joerg Bluemel

Director Toxicology within Biologics Safety Assessment / Translational Sciences
MedImmune, Gaithersburg MD

Joerg Bluemel is responsible for the nonclinical safety assessment and development strategy of bio-therapeutics in various indications. Dr. Bluemel is a board certified toxicologist and has more than 15 years of experience in nonclinical safety / nonclinical drug development for small molecules and bio-therapeutics. Prior to joining MedImmune, he was the Head of Nonclinical Safety / Drug Metabolism at Merz Pharmaceuticals GmbH, Germany.

Dr. Bluemel has an academic background in immunotoxicology and received his PhD from the University of Düsseldorf, Germany.



Date :February 20,2013

Professionals, Directors, VP, Managers involved in:

• Regulatory Affairs
• Scientific Affairs
• Patient Safety
• Economics
• R&D
• Legislation and Policy Advice
• Business Development: EU, USA and Emerging Markets
• Manufacturing
• Drug Development
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs
• APIs
• Intellectual Property   

Terms and Conditions

Registration provides individual access to live webinar and/or to the recording of the presentation. If a webinar is postponed due to unforeseen circumstances, the registrant is entitled to attend the rescheduled webinar or to receive a credit for a future webinar