Day 1 – 10th April, 2014
Meet :
Key note on Future of biosimilar industrySessions :
- Master class: Indian regulatory landscape
- Comparative study of regulatory guidelines between Developed and Emerging markets
- White Paper Submission: Examining the benefits of Product specific guidelines to have a single regulatory guideline across the globe
- Understanding Regulations and challenges in developing countries to device a proper entrance strategy
R&D Sessions:
- Face Off: R&D in India is not as per international levels, what is required to bring it to that level
- Understanding the future of QbD in biologics to make sure your companies processes and technologies are refined for Qbd implementation
- Case study: Approach of big companies in terms of R&D
- Understanding the aspects of tech transfer to develop a proper process for the same in your organisation.
Day 2 – 11th April, 2014
Meet:
Opening remarks from the ChairSessions:
- Panel Discussion: Ensuring the use of non infringing formulations to ease out the process of regulatory approval
- Studying the patent landscape carefully to get a better understanding of its effect on your organisation
- Panel Discussion: Changes required for a creating talent pool with university tie-ups for biosimilar R&D in India
Manufacturing Sessions:
- Understanding how to create a quality biosimilar at par with innovator molecules to build a strong product portfolio for your company.
- Learning about the outsourcing options available for manufacturing to choose the best fit for your organisation
- Panel discussion: Why is the manufacturing of biosimilars slow in India, Evaluating how to implement best practices to fast track drug production in India
- Building ways of tackling multiple product manufacturing to make sure your organisation has the right environment for each product
- Outsource it to us: 4 vendor presentation of 15 mins each from manufacturing facilities that do outsourced work
Who Should Attend!
R&D heads, Manufacturing Heads, Regulatory Heads, Biosimilar heads, VPs and General managers Chief Scientific officers
R&D heads, Manufacturing Heads, Regulatory Heads, Biosimilar heads, VPs and General managers Chief Scientific officers
