The Biosimilars Global Congress 2020 Europe is dedicated to various aspects in the field of Biosimilars.
The Biosimilars Global Congress 2020 Europe covers topics such as:
- 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- The effect of FDAs draft guidance, impending patent expiration, and role of exclusivity in patents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
The Biosimilars Global Congress 2020 Europe brings together 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
