Due to the high costs for product development, it is difficult for small and medium-sized pharmaceutical companies to take their product to the market on their own. By integrating project-specific development strategies and deliverables in the overall product development objectives can help develop a strategic roadmap to add value during product development which in turn can optimise exit strategies.
Join us on 16th May at 15:00 BST, 16:00 CEST, 10:00 EDT for this engaging webinar where Dr Niamh Kinsella, Biologics Expert, VP, Early Stage Development, NDA Group will cover the following strategies:
- See how to implement a stage-gate approach for the early development of your product
- See how a global regulatory strategy can be implemented
- Determine your strategy for agency interactions.
This webinar will enable you to reflect on how well your own plans are progressing and what more needs to be done.
The webinar will be followed by a Q&A session for you to receive direct feedback on key areas of uncertainty.
Click here to book your place today!
Dr Niamh Kinsella, Biologics Expert, VP, Early Stage Development, NDA Group.
Niamh has worked in regulatory affairs for over 15 years and has 5 years’ experience in biopharma industry prior to entering regulatory affairs. Niamh joined NDA in January 2010 and specialises in CMC / quality aspects of biological products, including recombinant proteins, monoclonal antibodies, vaccines and advanced therapy medicinal products. Niamh has strategic experience in CMC/quality and regulatory development throughout the product lifecycle and also has experience in regulatory operations in the preparation of documentation for regulatory submissions (Agency meetings, IMDS/INDs and MAAs/BLAs).