Biosimilars and Follow-on Biologics 2015 Americas

Paradigm Global Events is proud to present our flagship event Biosimilars and follow on Biologics 2015.

23-25 Feb 2015 at Washington, Washington, United States

Biotechnology, Pharmaceuticals/Drug Discovery

Biosimilars and Follow-on Biologics 2015 Americas 23-25 Feb 2015 Washington, Washington, United States
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The two – day Congress will provide and interactive discussion and networking format led by key industry expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts surrounding biosimilars.

Day one topics will focus on:
• Global Regulatory Perspective
• Current Regulations and future Challenges for the development of Biosimilars in Europe & US
• Regulatory Strategies in the Emerging Markets
• Harmonization
• Global Commercialization & Reimbursement
• Clinical & Non-Clinical
• Impact of Healthcare system on Biosimilars
• Patients perspective on Biosimilars
• Scientific and Clinical Considerations for Biologics and Biosimilars
• Harmonization to ensure patient safety
• Global Strategic Collaboration
• Including two interactive panel discussion on:

Day two topics will focus on:
• Update on FDA Development for Biosimilars
• Interchangeability – Guidelines
• Preparing for U.S. Market entry – strategy consideration in view of BPCIA
• Key Regulatory aspects for development and approval of Monoclonal Antibodies
• Manufacturing & development process considerations of Biosimilars
• Substitution and Interchangeability
• Challenges & Obstacles in Conducting Clinical Trials
• CMC requirement s for Biosimilars Product Development / Manufacturing
• Mass Spectrometry for Characterization & Comparability

Who should attend?

Chief Executives, Executive Directors, Vice Presidents, Heads and Team Leaders and Managers working within:

• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Biopharmaceuticals/ Biotherapeutics
• Legal Affairs
• Intellectual property
• Pricing and Reimbursement
• Clinical Immunology
• Regulatory Compliance
• R & D
• Preclinical and Clinical Development
• New Product Development
• Quality Affairs/ Quality Control
• Principal Scientist
• Pharmacovigilance
• Chief Scientific Officer
• Drug Safety & Risk Management
• Health Economics
• Process Control and Analytical Technologies
• Business Development
• Commercial Affairs
• Marketing & sales
• Intellectual Property
• Legislation and Policy Advice
• Business Development
• Licensing
• Manufacturing
• APIs
• Bioequivalence
• Drug and Safety Assessment
• Market Strategy
• Regulatory Affairs

From: February 23, 2015 08:00
To: February 25, 2015 18:00

Washington, Washington, United States


Biotechnology, Pharmaceuticals/Drug Discovery

Contact email

Contact phone
+44 20 7193 3485

External link

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