Program:
THE CONFERENCE MAIN TOPICS
Day 1: Regulatory and Ethical issues
Regulation related to the production of clinical-grade vectors: GMP, GLP,
Biosafety and certification of the facility, the process and the product
Regulation and review of gene therapy experiments and clinical trials
- in Europe: at the national level, at the European level
- in USA: FDA and NIH (RAC, ORDA, GTPC)
- harmonisation between Europe and USA: ICH
Requirements for early clinical trials
- relative degree of compliance to cGMPs
- risk-benefit evaluation in experimental therapies
Relation with Cell Therapy
Intellectual property
Ethical issues and public perception
Day 2: Scientific issues
Limitations of current vectors, their improvement
Design of new viral and non viral vectors
Targeting and integration of vectors
Animal models for the evaluation of vectors
Scientific issues driving development of the regulatory process
- testing
- detection of replication-competent virus
Scientific issues related to manufacturing
- scaling up
- downstream processing
Day 3: Technical issues
General design of a GMP facility
Clean room technology
Containment of GMOs
Specifications of facilities producing clinical-grade vectors
Technical issues related to manufacturing
- scaling up
- downstream processing
Validation
- process
- product
The Scientific Committee is finalizing the programme which will include lectures
given by prominent European and American scientists and experts, as well as by
key authorities of the European Commission (EC) and of the Food and Drug
Administration (FDA).
Registration :
Deadline for Abstracts: January 15th, 1998
Email for Requests and Registration: d.shanni@ecco-congress.be