The Workshop

Pre-conference workshop
The journey from initiative to submission
Date:	Tuesday 9 September 2008
Led by:	Dr. Ingrid Hanke Director Regulatory Affairs PHARMALEX
About the workshop:
Due to the complex nature of biosimilars products for which the benefit/risk profile must be carefully evaluated and monitored, a well defined and transparent regulatory framework covering development and approval procedures must be in place. In the last years, the first legal basis for this framework has been established by regulatory authorities in Europe, FDA in the United States is going through similar discussions on this topic too. In this workshop, Ingrid Hanke will analyse the key regulatory guidelines, importance of comparability, as well as how to assess the potential profitability of biosimilars. The audience will have the opportunity to take part in an interactive discussion, participate in smaller groups and share their experience and best practices.
Workshop agenda
13:30	Registration
14:00	Understanding the regulatory framework Legal provisions Development of the Biosimilar Guidelines and lessons learned so far Finding the correct regulatory pathways to follow - briefing meetings, scientific advice and centralised procedure Key elements of the dossier
15:30	Afternoon break
16:00	Key challenges in the development process Impact of changes in the manufacturing process Regulatory considerations for manufacturing and clinical trials How to do the comparability exercise Key players in the biosimilar market - in Europe and beyond Assessing the potential profitability of biosimilars Is interchangeability likely? Do’s and don’ts in drug development
17:30	Close of workshop
About your workshop leader:
Dr. Ingrid Hanke	Dr. Ingrid Hanke has an educational background in pharmacy and molecular biology. Dr Hanke received her doctorate from the University of Heidelberg. At PharmaLex International Dr Hanke holds the position of Director of Regulatory Affairs and has specialised in Biologics/Biosimilars and the strategic development of medicinal products. Dr Hanke is member of DIA, RAPS, BioDeutschland and DGRA.
PharmaLex International	PharmaLex International offers worldwide drug registration services to ensure trouble free processes. Depending upon the specific requirements, PharmaLex’s highly qualified registration experts evaluate the documentation in view of current guidelines, give strategic advice, compile a complete electronic dossier, and manage the entire registration process: Centralised Procedures (CP), MRP, DCP, national registrations, DMF and CEP processes, CTAs, Variations and Renewals.