Nonclinical and Clinical Safety Assessment of Biosimilars:
Part 2 – Regulatory Perspective
About this webinar
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 guidelines on Biosimilar mAbs
- EMA vs. FDA regulation including a discussion of WHO guidance
- Current global regulatory environment
- Case studies and ongoing challenges
Who should attend
- Regulatory Affairs
- Scientific Affairs
- Patient Safety
- Economics
- R&D
- Drug and Safety Assessment
- Legislation and Policy Advice
- Business Development: EU, USA and Emerging Markets
- Market Strategy
- Manufacturing
- Bioequivalence
- APIs
- Intellectual Property
Featured Speakers
Joerg Bluemel
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 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.
Partner for this event
eCademy
Developed through ongoing research and in-depth dialog with your peers, Xtalks eCademy provides a unique, best-in-class virtual learning experience for companies and individuals who wish to stay informed about recent developments in the life science industry. Our interactive online training courses are delivered by pharmaceutical, biotech and medical device industry experts to equip you with the knowledge needed to excel in your field of interest