Upcoming Event

workshop

Workshop Description:
This workshop will focus on how cell and gene therapies (advanced therapy medicinal products, “ATMPs”) should be prepared for clinical development to meet the requirements of regulatory authorities, particularly in the EU and US. We will provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. The content will include an overview of the applicable regulatory pathways and essential elements to address prior to application to perform clinical trials. This will include practical advice on “dos and don’ts” for product design and manufacturing platform selection. Attention to these factors is important in order to optimise product safety, avoid regulatory difficulties, and facilitate and expedite further development towards market authorisation. Some mistakes made at the beginning may be very costly to correct later in development, hence appropriate planning to avoid associated obstacles is critical for the credibility of programs with potential investors.

Topics:
For more information and to register, please visit the following links: