The Biosimilars Global Congress 2020 Europe is dedicated to various aspects in the field of Biosimilars.
Topics
- The non-clinical strategies and safety assessment to facilitate clinical and market entry efficiently Utilization of
- The effect of FDAs draft guidance, impending patent expiration, and role of exclusivity in patents
- CMC, mass spectrometry requirements to establish biosimilarity
- The strategies in place in developing and manufacturing biosimilars in emerging markets
- Challenges encountered with Extrapolations and inte changeability, assessing immunogenicity and Pharmacovigilance
- The pre-clinical and clinical challenges associated with the development of biosimilars and follow -on biologics
- The issues and implication of INNs
- Utilization of Clinical Pharmacology Data to Support a Demonstration of Biosimilarity
- The current global regulatory guidelines and considerations for developing and bringing the next generation of Biosimilars to circulation
Who should Attend
Senior attendees involved or interested in:
- Health Economics
- Bioequivalence
- Drug and Safety Assessment
- Legal Affairs
- Chief Scientific Officer
- Biologics/Biotechnology/ Biogenerics
- Pricing and Reimbursement
- Pharmacovigilance
- Regulatory Compliance
- Licensing
- Process Control and Analytical Technologies
- Manufacturing
- Intellectual property
- Market Strategy
- Commercial Affairs
- Preclinical and Clinical Development
- Drug Safety & Risk Management
- Marketing & sales
- Quality Affairs/ Quality Control
- Follow on Biologics/Follow on Proteins/Biosimilars
- Business Development
- Principal Scientist
- R & D
- Legislation and Policy Advice
- New Product Development
- APIs
- Clinical Immunology
- Regulatory Affairs
- Intellectual Property
- Business Development
- Biopharmaceuticals/ Biotherapeutics
