CALL FOR PODIUM AND POSTER PRESENTATIONS 

Inaugural
Vaccine Quality throughout the Life Cycle
Managing the interface between process change implementation,
analytical characterization and regulatory strategy
August 13-14, 2012 

In depth research with experts and leaders in the field reveals a major concern with the impact of process change on vaccine quality over the long vaccine life cycle.  This event brings together specialists from Process Development, Analytical Characterization, CMC, and Regulatory Strategy amongst others, to examine the important interface between the process, vaccine characterization, and interaction with the regulatory authorities. Risk analysis of whether to undertake change, and means of increasing the pace of change once a decision has been made will be examined. Attendees will discover how the experts adapt the process and set up panels of characterization tests for robust potency assays, physicochemical characterization, and for release. In addition, advice and industry experiences on working with the regulatory authorities around the globe will be covered. We plan to cover all stages of development, a range of prophylactic areas, a selection of cell lines including bacterial, plant, yeast, algae and insect, and a variety of vaccines including VLPs, subunit vaccines, recombinant vaccines, and monoclonal antibodies. This event will appeal to those in Process Development, Analytical Characterization, CMC, Quality and Regulatory amongst others.

We are looking for speakers for in-depth case-driven talks on the following and related topics: 

Process Development

• Management of process change and its impact on the product / risk assessment for implementing process change
• Adaptation of the process
• Introducing flexibility into the process and into regulatory filing
• Means of enhancing the pace of development (process development, clinical development and change implementation)
• Application of Quality by Design and Design Space to minimize regulatory interaction
• Tech transfer of production

Regulatory Strategy

• Working with the regulatory authorities (Europe, USA, India, China etc)
• Accommodating differences in quality systems around the globe

Characterization and Comparability

• Analytical characterization of vaccines and characterization to support process change
• Development of robust potency assays
• Release testing
• Tech transfer of analytical methods
• Managing changes in analytical technology
• Relationship between and physicochemical properties and efficacy
• Means of enhancing stability of vaccines / stability testing

If you are interested in presenting, please submit a proposal for review. Please note that due to limited speaking slots, preference is given to abstracts from those within pharmaceutical and biotech companies, regulators and those from academic centers. 

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. 

Please click here to submit your proposal.

The deadline for submission is February 13, 2012. 

For more details on the conference, please contact:Nicole Lyscom, Conference Producer
Phone: +44 1483 826359 • E-mail:nlyscom@healthtech.com

For partnering and sponsorship information, please contact:Suzanne Carroll, Manager, Business Development
Phone: 781-972-5452 • E-mail: scarroll@healthtech.com 

For media partnership opportunities, please contact:Tracey Fielding, Marketing Manager
Phone: 781-972-5429 • E-mail: tfielding@healthtech.com