What's On

Workshops on Cell and Gene Therapies: Preparing for International Clinical Development

02:00 PM - Tuesday 23 October, 2018
The Cell and Gene Therapies: Preparing for International Clinical Development workshops will be held in Melbourne on Tuesday, 23 October 2018 and in Sydney on Wednesday, 24 October 2018. 

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
Factors in the design of cell and gene therapies that impact acceptability to regulatory authorities in Aus, EU & US
Considerations in selection of the manufacturing platform
Essential product testing before entry into clinical trials
Pre-clinical studies that are relevant to the safety of cell and gene therapies
The value of regulatory strategies in the early development of cell and gene therapies

For more information and to register, please visit the following links:
Melbourne Workshop: Karstens, 123 Queen Street, Melbourne VIC 3000 
Sydney Workshop: The Kinghorn Cancer Centre, Level 11, 370 Victoria Street, Darlinghurst, NSW 2010